Highlights, Milestones and Challenges Report

Transcription

1 Highlights, Milestones and Challenges Report B1: What are the Major Goals? The major overall goals for this 5 year cycle of the Colorado Clinical and Translational Sciences Institute (CCTSI), as described in our grant application of 2013, are: Goal 1: Further enrich and expand our integrated statewide academic home for clinical and translational sciences across the entire translational research spectrum. Goal 2: Institute new Clinical Research Management strategies to strengthen quality, safety, efficiency, cost-effectiveness and innovative team science throughout our research enterprise Goal 3: Centralize and enhance the delivery of our resources, services and technologies to promote innovation and quality science. Goal 4: Infuse key concepts of community engagement into the full spectrum of translational research Goal 5: Increase the translational research workforce capacity through a broad curriculum of education and training opportunities. B2. What was accomplished under these goals? Highlights, Milestones and Challenges Report B2.1. Accomplishments of Colorado Clinical and Translational Sciences Institute (CCTSI) in Year 2 (7) ( ) B Program Integration, Innovation, Significance and Impact. Year 2 of this cycle was devoted to continue to transform the CCTSI 1.0 into CCTSI 2.0 at UC Denver and its partner institutions/affiliates. The growing recognition of the value of the CCTSI resources at all four campus and hospital affiliate sites and in the collaborative communities continued to bring increased visibility, increased productivity and increased importance of the CCTSI to clinical and translational research programs at UC Denver. The major change that affected all CCTSI institutions was the mandated annual NIH funding reductions to meet the new total budget target for year 5, which was based on institutional (including partners) total NIH funding in 2012 x 3%. This resulted in reduction of our NIH UL1, TL1 and KL2 funding from approximately $15.1 million in year 1 to $8.4 million in year 2. Fortunately, increased institutional support from UC Denver, the School of Medicine (SOM), University of Colorado Hospital (UCH), Children s Hospital Colorado (CHCO) and the other affiliates combined with our phased-in program income system, MicroGrants (voucher) and BERD Seeds programs made up most of this reduction for year 2. In year 2, Colorado State University (CSU), our newest CCTSI partner institution, was fully integrated into the CCTSI, evidenced by a substantial increase in the number of CCTSI members from CSU, the number of pilot grant applications submitted by CSU investigators, incorporation and development of two new Translational Technology Cores at CSU, new collaborations between CSU and CU faculty, and the success of the CU-CSU CCTSI Summits. We are also in the process of installing several new software systems that will greatly enhance our efficiency in conducting and monitoring clinical and translational research, including ilabs Solutions (Core Laboratories Management System), OnCore (Clinical Trials Management System), and Health Data Compass (our new Enterprise Data Warehouse). Thus, transitions initiated in grant year 1 are well on their way to being completely integrated into the functioning of CCTSI activities. Several new programs initiated in year 1-2 have taken off, including our Research Studio program, the Pragmatic Trials/Dissemination-Implementation Core, and the integration of CSU into the CCTSI. The restructured CCTSI organization is functioning well, the program income system is being phased in without major difficulties, and our pilot grant programs, informatics core, community engagement program, regulatory support program (Enhanced Research Environment), and other Cores and programs are proceeding according to the plans outlined in our funded CTSA grant application. New innovative programs that continue to grow in importance to our investigator community include the CO-Mentor program, the K to R Transition grant review program, the Clinical Faculty Scholar training program, our Clinical Sciences Master s and PhD graduate programs, our Biomedical Informatics initiatives, and our Child Maternal Health and pregnancy research support services. A new Pre-K award grant review program (study section that reviews new K-grants prior to NIH submission) was initiated in year 2 and is currently being evaluated. The CCSTI programs are well integrated with each other through the efforts of the Executive Committee, which meets for minutes twice per month. The centralized and shared administrative support of the 5 CCTSI Page -1-

2 Pillar Programs ensures integration of operations and excellent communication among programs. Our ETCD programs, BERD program, Evaluation and Tracking Core and Informatics Program activities permeate throughout all Cores and Programs. The implementation of our MicroGrants and BERD Seeds to balance the effects of our Program Income System and charge-backs to investigators are among the new innovative, novel initiatives continuing in Year 2. Our Community Engagement and Research Program continues to set the pace for innovation in this area (see individual Component report) including our BootCamp Translation program, Immersion programs, and Pilot grants program. Importantly, our Community Engagement Pilot Grant Program has become the template for the PCORI community pipeline pilot grant program. Moreover, our Community Engagement Core, through our partnership with the Colorado Foundation for Public Health and the Environment, is managing the review and awarding of the PCORI Pipeline to the Community grants for the Western United States. One of the most significant accomplishments continues to be the CCTSI installation and upgrades to our highly utilized Website (6,000 visits per month) and the very successful Colorado Profiles faculty information database (6,000-8,000 visits per month). These CCTSI resources have transformed how investigators, inventors, private industry, and trainees find expertise, collaboration or mentors, and how they approach obtaining assistance and training for their research. Impact of new Organizational Structure. The overall organizational structure of the CCTSI has been reengineered as proposed and now includes five Pillar Programs and an Administrative Core (see Figure 1). This streamlined structure has allowed the CCTSI to align optimally with the CTSA FOA to which our grant application responded and the IOM report on the CTSA program. The CCTSI is composed of operational units, each under the direction of an Associate CCTSI Director. Thus, the five Pillar Programs include 1) Translational Pilot Program, 2) Enhanced Research Environment Program, 3) Clinical and Translational Resources & Services (R&S), 4) Education, Training and Career Development (ETCD), and 5) Translational Informatics. Each Pillar Program includes defined Cores and smaller Programs (see Figure 1). Many of the former independent Cores are now included in these larger Pillar Programs and will report to the Associate CCTSI Directors for each of these Programs. The Administrative Core is overseen by the CCTSI P.I. and Director; Dr. Sokol, and Mr. Tim Lockie, the finance and administrative director. In addition, two new administrative positions have been added. Because of the new Program Income System requirements and substantial operational and budgetary changes that will be essential over the 5 years of this grant cycle, a new Operations Director position was created and Janine Higgins, PhD was appointed to this position in February, 2014 after an internal search. Dr. Higgins has been instrumental in implementing the new re-organization of the Cores and Programs, identifying new efficiencies in operations, implementing and tracking metrics for productivity of each Core, and has worked with Dr. Sokol and Mr. Lockie to determine appropriate funding levels for each Core. Dr. Higgins remains the Director of Bionutrition (20-30% effort) and will dedicate 50-60% of her effort to the new Operations Director position. A new Business Operations Manager is working with Mr. Lockie to develop and oversee the financial operations of the Program Income System and oversee the implementation of the new ilabs System for tracking of CCTSI Core Resources and Programs (see component report on CTR Resources and Services). The new Quality and Process Improvement Program (QPIP; which reports to the Administrative Core) became very active during year 2. In an effort to improve the efficiency and coordination of research protocol review and approval, and shorten the time to IRB, Hospital and SARC approval, the QPIP team engaged with Alison Page -2-

3 Lakin and her staff in the Enhanced Research Environment Pillar Program in a comprehensive review and redesign of the Pre-IRB Review Process utilized for research conducted on the Anschutz campus, with specific emphasis upon non-industry (e.g., NIH-funded) research. The effort had a goal of producing a unified Pre-IRB review process for CHCO, UCH, SARC, and UCD; a single port of entry for all investigators; a single approval letter for all protocols; and a tracking system (automated), and the use of metrics to identify performance of each partner, and sub process. The result of these efforts in Year 1-2 is a re-engineered process (entitled the Human Subjects Research Portal went live 8/14/2014 ( which has dramatically changed the work flow for research protocol submission and review at UC Denver. The QPIP team has now begun work with Nichole Carlson, Director of the BERD Core Program, to analyze and redesign key processes associated with the use of the BERD for biostatistical support by CCTSI member faculty and trainees, with the goal of further improving efficiency, financial sustainability and user satisfaction of BERD services and collaborations. Many new processes have been put in place to assist investigators with better study design, IRB protocol submission, enrollment and recruitment, and completion and monitoring of studies (see Component report for Enhanced Research Environment for details). Program Governance. No changes in program governance were made in year 2. However, leadership at UC Denver is undergoing changes. The Vice Chancellor for Health Affairs, Richard Krugman, MD, will be stepping down in April 2015 and John Reilly, Jr., MD from the University of Pittsburgh has been chosen as the next VCHA, to whom the CCTSI Director, Dr. Ronald Sokol reports. Dr. Sokol also reports to the Vice Chancellor of Research (VCR), Richard Traystman, PhD. In addition, there has been a change in leadership for the UC Denver Anschutz Medical Center campus. Mr. Donald Elliman has assumed the position of Chancellor of this campus and will replace Lilly Marks as the institutional official responsible for AMC. Our External Advisory Committee (EAC) met in January 2015 and provided its report that is included in this RPPR. Two new members were added to the EAC, James Heubi, MD from University of Cincinnati and Steven Dubinett, MD from UCLA. Jennifer Puck, MD was retired from the EAC. Programs and Cores. Highlights, restructuring and accomplishments of each of the CCTSI Pillar Programs that are directly funded by the NIH CTSA grant funds are provided as individual Component reports. NOTE THAT CCTSI COMPONENTS THAT RECEIVE NO DIRECT NIH SUPPORT DID NOT PROVIDE REPORTS, AS PER THE NCATS INSTRUCTIONS WE HAVE RECEIVED. Achievement of Last Year s Milestones. Implementation of the CCTSI plans are on track according to the milestones outlined in our CTSA renewal grant application, with continuous monitoring of progress being performed by the Tracking, Assessment & Evaluation Core. Each program/core is running according to the projected milestones with few exceptions. See the Evaluation Core component report for details. B Challenges and Their Management. Implementation: The implementation of the restructuring and re-engineering of the CCTSI has been conducted on schedule and without unexpected challenges. For example, the QPIP is far ahead in its mission to streamline and improve efficiency in our research processes at UCD, CHCO and UCH. In addition, the Operations Director and Operations Business Manager positions have been filled and have contributed to improve operations and efficiency. The new Pragmatic Trials/ Dissemination- Implementation Core is fully operational. Two critical infrastructure electronic systems, that underwent delayed approval by UCH and UC Denver in Year 1, are now on track for implementation during Years 2-3 of the grant cycle. OnCore has been purchased as the Clinical Research Management System for UCH and UC Denver and is live with new protocols being transitioned to OnCore for three research groups as well as the Cancer Center. The ILabs Solutions core lab management system is now live and being rolled out at a rate of 3-4 CCTSI or Cancer Center Core Labs each 2-4 months. All major Programs and Cores are operational and either meeting defined metrics for each objective or the reasons for delay in implementation are being addressed by the Program or Core Director with Dr. Sokol and Mr. Lockie. Objectives and metrics have been finalized for year 3 and are being collected by the Tracking, Assessment and Evaluation Core or by our new infrastructure systems. We have also developed new methods for collecting metrics for year 2 and beyond, particularly regarding Page -3-

4 publications derived from CCTSI support, follow-on grant funding for pilot awards, career development, patents and INDs/IDEs. Adjustments to Budget Reductions: The major challenge for the CCTSI during this five year cycle will be addressing our annual reduction in NIH funding for Years 2-5 of about $1.5M per year. Although our institutional support has increased, it will not completely offset the 42% decrease in NIH funding by Year 5. Program support will be reduced annually for certain programs, while critical programs (e.g., the Clinical Sciences Graduate Programs) will maintain full funding. The roll out of charge-backs for Research Nursing services in the CTRCs will begin in July We have already heard from some major CTRC research user groups that may have to find alternative sites for conducting their research since their NIH grant budgets do not allow for additional research nursing charges. We believe this problem may become more frequent with the new NCATS policy to shift all clinical research unit procedure, nursing and facility costs (except for KL2 and Pilot awardees) from CTSA budgets to the NIH Institutes /Centers budgets. In the experience of our investigators, their project officers at I/Cs did not know about this change in NCATS policy and do not have additional funds in their budgets to account for these expenses. This has led us to begin to re-examine expanding our MicroGrants program eligibility to more senior investigators that have NIH or other extramural grant support, although our MicroGrants budget is also finite. We have not yet developed a solution for this very important consequence of requiring investigators to pay for use of CTRC units. Currently, we do not charge for space use of CTRC rooms, nor do we plan to institute this charge during this funding period. With continued reduction of our NIH budget annually during coming years, the CCTSI leadership will need to continue to develop business plans for Year 2-5 and make decisions on eliminating those programs which are least utilized in order to continue to support the most important programs. This planning process is outlined in our funded CTSA grant application.b Plans for Shift in Activities Plans for year 3 do not include a major shift in activities as outlined by our funded Grant Application. However there are a number of changes in systems and operations that will results in a change in our work flows. A Program Income System has been implemented in a phased-in sequence. We will still maintain robust programs, but must look at increasing ways to be more cost-effective. For this reason, a new Quality and Process Improvement Program (QPIP) was created to generate new efficiencies. Institutional support has also been increased to offset some of the NIH funding reductions. We will engage in continuous improvements in the CCTSI website portal. We will continue to expand our clinical trials capabilities by partnering with the UC Comprehensive Cancer Center and leveraging their resources. Under Alison Lakin s direction, efforts have been initiated and will be continued to streamline and integrate CTRC SARC, IRB and Hospital Research Committee reviews and approval of research protocols in order to reduce time from submission to implementation. UCH and UC Denver will be implementing OnCore, a clinical research management system which will eventually being required for all clinical trials at UCH. This is being overseen by Dr. Lakin, our Associate Director. The CCTSI is also implementing the ILabs Solutions software to allow more efficient tracking, invoicing and reporting of our NeTT and CTRC Core laboratory activities. In Year 3 of the current 5-year grant cycle, we are not planning to make major changes other than those outlined and approved in our grant application. We are not requesting the shifting of funds between the linked CTSA grant awards for Year 3. New programs being developed in Year 3 (which are all contained in our funded Grant Application) are: 1. Initiate a Natural Animal Models Core and a PK/PD/PG Core for the NeTT at CSU. 2. Continue a new CSU-CU Collaborative Pilot Grant program that requires a co-pi at CU and CSU for eligibility of these $60,000 one year pilot grant awards. 3. Work with the Department of Medicine, the UC Cancer Center, the VC for Research and the Dean of the School of Medicine in further developing the new Center for Biomedical Informatics and Personalized Medicine at UC Denver. 4. Implement OnCore as the new CRMS for UCH and UC Denver clinical trials and other clinical research 5. Institute a Program Income System (including the implementation of ILabs Solutions software) to inform investigators and sponsors of the value that the CCTSI provides in support of research, and to implement charge-backs and fee-for-service models for CCTSI Resources and Services. 6. Work with CHCO, UCH, UPI and UC Denver to develop research data warehousing capabilities within the Enterprise Data Warehouse (Compass), under the direction of Michael Kahn, MD, PhD 7. Examine our administrative structure of key programs for improved efficiencies using the QPIP program. Page -4-

5 B Institutional Commitments and Support and Institutional Commitment for the Coming Year. Institutional support has been received as planned for the Administrative Core, Tracking, Assessment and Evaluation Core, Enhanced Research Environment (Regulatory Knowledge and Support) Pillar Program, $500,000 from the SOM for the CO-Pilot and Community engagement pilot grant programs, and 25% of each faculty member s CTSI effort (provided by the faculty s home school/college). Each of the Affiliates have outlined institutional commitment and in-kind support for facilities related costs, nursing related costs, and (in some cases) exemption from institutional F&A charges. Children s Hospital Colorado has also committed funds for Year 3 to continue to support two Translational Scientist Research Scholars (KL2-like) and funding of $100,000 per year for Child-Maternal Health pilot awards, support for the CHCO CCRO, and does not charge the CCTSI rent for the Core Lab or the outpatient research clinic. CHCO also supports the CTRC cost center with $1.2 million per year to support research nursing, core laboratory and biostatistician salaries, MicroGrants for CHCO CTRC, core laboratory expenses and bionutrition. UCH will continue to support the CCTSI with $1.175 million of funds to be used under the discretion of the CCTSI. UCH and NJH have reduced rent charges for outpatient and inpatient CCTSI research facilities. In addition, each KL2 Research Scholar receives $25,000 per year support and each Clinical Faculty Scholar receives $10,000 support from their academic division. The Dean of the SOM SIRC program will continue to supply an additional $600,000 per year to support Translational Technology Core program development in the area of research imaging (C-TRIC) and the Genomics and Personalized Medicine Core. The total Institutional support for year 3 will be approximately $7.2 million. B Impact of the academic home on partner institutions and how the program facilitates multisite research of investigators in the academic home. Academic Home and Multisite Studies. The relationships between UC Denver, the six Hospital Affiliates and CU Boulder and CSU, are very much enhanced by the CCTSI programs. Faculty at each of our affiliates and UC Denver derive many benefits from being a Member of the CCTSI, including access to the CO- Mentor program, the K to R Transition program, and many training and career development opportunities. The CCTSI enhances multi-site studies in many ways, including the availability of CTRCs at four institutions, which include space, expert research nursing, specimen processing and Core Laboratories, as well as unique equipment and services (e.g., PET-CT scanner, vascular ultrasonography, ECHOcardiography, and DXA scanning). Many NIH funded Research Networks use these services to facilitate multi-site studies in pregnant women, infants, children, adolescents and adults. In addition, the many activities (see Component report) of our Enhanced Research Environment Pillar Program are being instituted to assist investigators with more rapid IRB, Hospital and SARC committee approval of newly proposed research protocols; assistance with recruiting and enrolling subjects; improved and more rapid UC Denver contracting with research sponsors. The CCTSI is involved in several NACTS/CTSA consortium projects designed to facilitate multi-site research, including the Accrual in Clinical Trials project, Good Clinical Practice training program, IRB reliance agreement program, and the Contracting Template project. B Shift in Funds between Linked CCTSI Grants. No request is being made to shift funds between the CTSA UL1, TL1 and KL2 grant awards provided to the CCTSI by NCATS. Page -5-

6 Self-Evaluation Report A and B. Conceptual Framework and Objectives: CCTSI has established five Strategic Goals, which serve as guideposts for the Evaluation Center s (TEC) external evaluation. By catalyzing quality and process improvement and ascertaining key program impacts through responsive tracking, assessment and evaluation, TEC helps inform and assess progress toward achieving these goals, as well as the specific aims of pillar programs. Key evaluation questions that guide the external evaluation of the CCTSI, and their alignment with these strategic goals and specific aims, are presented in Exhibit 1. Exhibit 1: Key Evaluation Questions and Alignment with CCTSI Strategic Goals, Pillar Specific Aims Key Evaluation Question Strategic Goal Pillar Specific Aim 1. How are quality and process improvements enhancing the environment for CTR at CCTSI affiliated organizations? How are changes to the regulatory processes of CCTSI affiliated organizations affecting investigator satisfaction and cycle times as they relate to the three CTSA supported metrics: a) time from institutional review board (IRB) submission to approval; b) studies meeting accrual goals, and c) time from NOGA to first accrual? 2. What is the evidence that the CCTSI is addressing the research support/service needs of CTR investigators across CCTSI affiliated institutions and the translational research spectrum? 3. What is the evidence that key concepts of community engagement are being integrated into the full spectrum of CTR studies? [primary question for Community Consult and Research Studio Programs] What evidence exists that community campus partnerships are established and sustained? [one of two metrics used to operationalize social return on investment ] 4. What is the financial and social return on investment of CCTSI supported research? What is the evidence that CCTSI resources and services are actively supporting the translation (i.e., dissemination and implementation) of results/products emanating from CCTSIsupported studies? [translation or application of results/products is the second metric used to operationalize social return on investment 5. What is the evidence that the ETCD pillar: a. Effectively recruits and supports the retention of a diverse CTR workforce? b. Addresses the workforce development needs of diverse investigator communities? c. Adequately prepares trainees, scholars for productive CTR careers? d. Is promoting a culture of effective mentorship? #2: Institute new clinical research management strategies to strengthen quality, safety, efficiency, cost effectiveness and innovative team science, #2: Institute new clinical research management strategies to strengthen quality, safety, efficiency, cost effectiveness and innovative team science, #3: Centralize and enhance the cost effective delivery of CTR resources and services #4: Infuse key concepts of community engagement into the full spectrum of translational research #1: Enrich and expand the integrated statewide academic home for clinical and translational research #5: Increase translational research workforce capacity through a broad curriculum of education, training and career development opportunities Research Environment: Catalyze quality and process improvement and ascertain key program impacts through responsive tracking, assessment and evaluation. (SA4) Resources and Services: Develop and implement a Program Income System and an evaluative process for costeffective allocation of resources that supports the planning, conduct, analysis, and dissemination of research results. (SA1) Resources and Services: Optimize the infrastructure for implementing and tracking research and support services. (SA2) Research Environment: Ascertain key program impacts through responsive tracking, assessment and evaluation. (SA4) Resources and Services: Develop and implement an evaluative process for cost effective allocation of resources that supports the planning, conduct, analysis, and dissemination of research results. (SA1) The questions included here are the key questions that framed the ETCD evaluation plan and design as presented in the CCTSI grant. C, D and G. Milestones, Variables Measured, Type of Data Collected and Timeline: See Exhibit 2. Exhibit 2: Evaluation Year 2 Scope of Work (prioritized with the CCTSI Executive Committee) Pillar Metrics (Variables Measured) Data Collection Methods Timeline (progress) 1 Page -6-

7 Research Environment Pilot program tracking (CO Pilot including CSU/CU Collaborative awards, CMH, CE, NCTMD) Standard research productivity metrics: followon funding, publications, patents Social return on investment (expanded network of academicians and communities engaged in CTR; translation of findings/products into practice) Cycle time metrics associated with scientific and regulatory review/approval for investigator initiated studies: 1. Time from institutional review board (IRB) submission to approval 2. Studies meeting accrual goals 3. Time from notice of grant award (NOGA) to first accrual Workflow analyses of scientific and regulatory review of investigator initiated studies 6 and 12 month progress reports Annual follow up surveys thereafter ROI calculations Longitudinal follow up interviews with Community Engagement pilot awardees to track same productivity metrics, as well as sustainability and expansion of community campus partnership efforts Quantitative trend analysis of institutional data Examine temporal associations between changes in cycle times with process improvements Key informant interviews with key administrators Triangulate with process flow diagrams and needs assessment data In progress (ongoing) In progress (ongoing) Annually Longitudinal follow up with Cohort 1 complete; additional interviews with Cohorts 2 and 3 to be conducted this spring (stories featured in CCTSI newsletter, on website) The Research Environment Pillar began using OnCore for protocol tracking in Spring However, not all of the data needed to track these metrics is currently being entered. Specifically, a link between award and IRB number is not yet in place. Year 3 Resources and Services Recruitment and retention of research study subjects: Studies meeting accrual goals Time from notice of grant award (NOGA) to first accrual Needs Assessment Utilization Satisfaction Need (access/availability, importance to research) Balanced scorecard approach Consolidate multiple types of information to create a holistic assessment of resources & services provided through the CCTSI Research Studios (facilitate research across the life cycle of projects by providing strategic direction, support and guidance to overcome stumbling blocks) Specific outcomes tracked depend on the stage of research addressed and the specific issue that serves as the focus of the studio Quantitative data analysis of trends in institutional data across cross section of CCTSI supported studies (e.g., CTRC studies) Needs assessment survey administered to CCTSI members and non members at Anschutz Medical Campus, as well as members at affiliated organizations Client satisfaction survey (recently launched) Utilization data (collected quarterly based on standardized process and data points established with R&S steering committee) Needs assessment data Application data provide demographic information on participants, as well as information on studio type Program monitoring information (includes information on expert panelists organizational affiliation, sector, etc.) Formative feedback from investigator participants and expert panelists (collected immediately following each studio) 6 month follow up form designed to track outcomes (shortened version to be used at 12 months) To be initiated with the establishment of centralized data systems for collecting institutional data Year 1 (completed; evaluators provided a comprehensive summary of findings to CCTSI leadership, as well as detailed, tailored reports of relevant findings to each pillar leader/steering committee; results helped surface need for QPIP intervention related to BERD) Year 4 Data will be compiled annually to inform decision making around allocation of funds Comprehensive evaluation plan developed and approved by senior leadership Evaluation instruments developed No evaluation data collected with these instruments have yet been provided by the program for analysis by the evaluation team 2 Page -7-

8 ETCD Community Consults Distribution of consults to support research across the translational spectrum, including in the conceptualization and planning stages of T1 research studies Types of issues addressed during consults Investigator demographics Community representation (as consultants) Spin offs that expand the infrastructure and capacity to support community engagement in CTR research (sustained relationships, establishment of community advisory boards, etc.) Community immersion program Increased knowledge/ understanding of: CBPR (e.g., principles, philosophy) Steps to take in the early stages of a CBPR project Social and cultural determinants of health (e.g., issues facing a particular community; the cultural and historical context of a particular community) Self awareness about implicit bias, and How to present yourself and behave in community settings Establishment of relationships with individuals and entities in community based settings as a foundational aspect of CBPR Intentions to pursue CBPR projects KL2 TL1 KTR Transition to independent (R) funding (compare success rates to national and institutional benchmarks) Persistence in CTR careers Motivation (intrinsic and extrinsic) Effective mentorship support CTR competencies (including leadership development) Pursuit of education/training and careers related to CTR (compared to doctoral student peers) Successful transition to independent R level funding (compare success rates to national and institutional benchmarks) Pre K Mock Study Section Career development award rates Application data to track demographic information on participants, as well as information on consult type (issue, type of research, etc.) Program monitoring information (includes information on consultants organizational affiliation, background, etc.) Formative feedback from investigators Secondary data analysis of associated reports produced by program administrators and investigators as part of the formal documentation of process (guidance and response) 6 month follow up designed to track outcomes (shortened version to be used at 12 months) Secondary data analysis of threaded discussions and participant reflections Thematic summary of content analysis provided in a formal report that presents emergent evidence of desired outcomes (as per program logic model) and recommendations Evaluation findings are presented and discussed annually at planning meetings and informs program refinement Longitudinal tracking/follow up (key informant interviews with scholars who completed the program 2+ yrs ago to track the achievement of career milestones and explore context of persistence decisions) Key informant interviews Review of transcripts, CVs and/or institutional data Feedback survey administered one month following program participation (focus: formative feedback and impact on grant refinement/submission) 6 month and 12 month follow up surveys thereafter to track outcomes *KTR mock study sections occur three times annually: September, January, May Feedback survey administered one month following program participation (focus: formative feedback and impact on grant refinement/submission) 6 month and 12 month follow up surveys thereafter to track outcomes *Pre K mock study sections occur three times annually: September, January, May Comprehensive evaluation plan developed and approved by senior leadership Developed comprehensive matrix to help stakeholders understand the distinction between the Research Studio and Community Consult programs, as well as other CCTSI supported consults to clarify goals, roles Instruments have not been developed, but will likely be modeled off of Research Studio forms Formal report of the 2014 program provided to planning committee Oct 2014 Findings, recommendations discussed and used to plan 2015 program Logic model and evaluation plan refined based on 2014 report and findings 7 KL2 scholar interviews were conducted in 2014 Preliminary analysis conducted Summer 2014 Exploring a more robust theoretical framework than Self Determination Theory to interpret these data (SDT was used for a similar national study) 4 more interviews to be completed Fall 2015 To be initiated Spring 2015 In progress (ongoing) Formal feedback reports were provided following each session 6 month and 12 month outcomes reports also provided semiannually Created a longitudinal tracking database to support the tracking of grant submissions and awards Comprehensive evaluation plan developed and approved by senior leadership Evaluation instruments developed Formal report of the 2014 program provided to planning committee Oct 2014 Findings, recommendations discussed and used to plan 2015 program 3 Page -8-

9 CO Mentor Goal: Enhance environment for mentorship by providing specific training on how to be an effective mentor and mentee Metrics: Mentors and mentees develop expanded mentorship support networks and report effective mentorship support LITeS Enhanced management of self and others Changes in practices, policies and built environment to promote team science Initial program assessment Final program assessment (matched pre/post comparisons to assess outcomes) 6 month follow up interviews with mentee participants Key informant interviews with mentors to document impact of program on their professional development and skills as a mentor Final program assessment Key informant interviews with institutional leaders to learn about institutional response to team projects and recommendations Identification of artifacts to use to document response by institutional officials Annually (October) for incoming cohort (associated report for current cohort was produced Nov 2014; included recommendations re: tailoring the training based on findings) Annually (April) immediately following final session; associated report for last year s produced in May 2014 Conducted Oct 2014; report disseminated Dec 2014 To be initiated Spring 2015 April 2014 Ongoing E. Human Subjects Protection: Those who contribute data to evaluation efforts are apprised of the voluntary nature of their participation, who can access the data they provide, as well as how data will be stored and reported, and for what purpose(s). The role of TEC as the CCTSI external evaluator is carefully explained prior to initiating data collection efforts. Furthermore, TEC often engages those who contribute data for evaluation studies in members checks to verify the validity of interpretations/findings prior to finalizing reports/products for dissemination. Colorado Multiple Institutional Review Board (COMIRB) approval is sought for any evaluation study that is intended to yield generalizable findings. F. Summary of Findings: Here, we present key findings related to the overarching evaluation questions. Key Evaluation Question Key Findings 1. How are quality and process improvements enhancing the environment for CTR at CCTSI affiliated organizations? To be reported in subsequent years after quality and process improvement efforts related to the regulatory approval process and allocation of BERD resources have gained more traction and have longer to take effect. With regard to the former, more institutional data is needed at this time to assess trends. 2. What is the evidence that the CCTSI is addressing the research support/service needs of CTR investigators across CCTSIaffiliated institutions and the translational research spectrum? 3. What is the evidence that key concepts of community engagement are integrated into the full spectrum of CTR studies? 4. What is the financial and social return on investment of CCTSI supported research? What is the evidence that CCTSI Evaluators conducted an institute and campus wide needs assessment in 2014 to determine to what degree the research needs of the investigator community were being met. Key findings included: Resources and Services Pillar Level Findings: The 3 most needed and/or utilized resources and services were CCTSI Translational Bioinformatics Support (53%), CCTSI Biostatistical Support (48%), and the services provided through the Clinical Research Support Center (38%). CTRCs: The most important CTRC sites to respondents were the UCH Outpatient CTRC (75%), CHCO Outpatient CTRC (68%), UCH Inpatient CTRC (63%), and CHCO Inpatient CTRC (63%). These are the percentages of respondents who indicated that a given CTRC was somewhat or very important to their research. 27% of respondents planned to use the UCH Outpatient CTRC more frequently in the future, 26% planned to use the CHCO Outpatient CTRC more frequently, and 24% planned on using the CHCO Inpatient CTRC more frequently. 86% of respondents planned to use the UCH Outpatient CTRC about the same or more in the future. 84% of planned to use the UCH Inpatient CTRC with about the same or more frequency in the future. To be reported in subsequent years, after more data are available on Research Studio and Community Consult programs. Initial summative reports are scheduled to be developed July Financial return on investment (ROI) values are calculated for each of the CCTSI pilot programs, by cohort. The ROI values shown below represent the number of follow on dollars awarded per dollar of CCTSI pilot award funding. Pilot Cohort Total CCTSI awards ($) Total Follow on Funding ($) ROI 2009 CMH 170,756 1,614, Page -9-

10 resources and services are actively supporting the translation (i.e., dissemination and implementation) of results/products emanating from CCTSI supported studies? 5. What is the evidence that the ETCD pillar: a. Effectively recruits and supports the retention of a diverse CTR workforce? b. Addresses the workforce development needs of diverse investigator communities? c. Adequately prepares trainees, scholars for productive CTR careers? d. Is promoting a culture of effective mentorship? 2010 CMH 159, , CMH 179, , CMH 179, , CO Pilot 553,500 7,351, CO Pilot 1,081,870 6,660, CO Pilot 410,000 1,538, CO Pilot 400,000 1,547, CE 292,742 5,903, CE 202,531 1,680, CE 206, , CE 190, a and c. TEC developed a comprehensive database to track the demographics and academic and career milestones of ETCD participants, including mentors. This work surfaced gaps in information that is needed to address this evaluation question. Efforts are currently being undertaken to establish processes and tools for ensuring that these types of information are collected systematically for each ETCD program. b and c. The comprehensive needs assessment (described above) surfaced the following as the ETCD priorities of CTR investigators: Biostatistics, Leadership Development, Career Development Award Education and Review, Mentorship and Biomedical Informatics. In response, the ETCD steering committee has devoted time during several meetings to strategize ways to respond. For example, ETCD program directors have brainstormed ways to enhance biostatistical support and training within the context of their programs. d. Through longitudinal follow up interviews, mentee participants of the CO Mentor training program reported gaining skills that corresponded with each of the domains of Self Determination Theory. SDT elucidates a causal pathway by which effective mentorship is linked to persistence vis à vis motivation. H. Participation in the National CTSA Evaluation: In October 2014, TEC presented a paper and poster at the American Evaluation Association annual meeting that showcased our approaches to evaluating the Enhanced Research Environment and Resources and Services pillars: Implementing an Evaluation using a Balanced Scorecard: Assessing the Value of Resources and Services for Long-Term Sustainability and Evaluation and Quality and Process Improvement: Aligning Complementary Expertise and Methods to Achieve Systems-level Change. A lead evaluator for the CCTSI (Nearing) is serving as the lead author on an overview article for an education series to be featured in Clinical and Translational Science: Diversifying the Clinical and Translational Research Workforce: Best Practices for Expanding the Pipeline; multiple staff in the Evaluation Center are co-authoring this paper. The second lead evaluator (Proctor) and TEC colleague (Buckley) supported the development of the following paper that was submitted to Implementation Science and is currently under review: Bringing it Home: Expanding the Reach and Spread of Dissemination and Implementation Training via a University-Based Training Workshop and Accompanying Online Resources. 5 Page -10-

11 Overview of Resources and Services Pillar B1: What are the Major Goals? The Clinical and Translational Research Resources and Services Pillar program (CTR R&S) includes the following components for which separate reports will be submitted: Clinical and Translational Research Centers (CTRCs) Biostatistics, Epidemiology, and Research Design (BERD) Community Engagement and Research Child and Maternal Health Research The CTR R&S included the following overarching goals that involve multiple components and were, therefore, not addressed by individual components: 1. Develop and implement a Program Income System and an evaluative process for cost-effective allocation of resources that supports planning, conduct, analysis, and dissemination of research results. 2. Optimize the infrastructure for implementing and tracking research and support services. 3. Strengthen our integrated Network of Translational Technologies (NeTT) and laboratories that provide stateof-the-science services for comprehensive clinical and translational research. B1a: Have the Major Goals changed? No B2: What was accomplished? Program Income System: The specific goal of the Program Income System is to transition to a fee-for-service model for the components of the CTR R&S that provide services to investigators. The plan was to undergo a gradual transition to fee-forservice over the first 3 years of the CTSA and we are on track to meet this goal. All of the involved CTR R&S units at CU-AMC and the affiliate institutions have developed Service Centers, which enable them to charge for services in a manner that is compliant with institutional regulations. As part of this process, costs analyses were conducted to establish tiered fee structures for federally sponsored and privately sponsored projects. It was expected that the implementation of a fee-for-service model would introduce financial barriers to conducting pilot and feasibility studies, particularly for junior investigators, which are often necessary to advance innovative research ideas. To address this we established a MicroGrants Program that is supported by institutional funds Investigators can apply for awards (up to $10,000 per year for 3 years) that can be used to cover the cost of CTRC services. Because the funds for this program were provided by Children s Hospital Colorado (CHCO) and University of Colorado Hospital (UCH), these awards are limited to investigators who utilize the CTRC units at these institutions. As of January 2015, a total of 36 MicroGrants had been awarded. A second program, BERD Seeds, was also established in the last grant year to subsidize the cost of biostatistical consulting support. Junior investigators can apply for up to 40 hours of support at no cost; additional support is available at a highly subsidized reduced rate to all investigators ($35/h). Because the funds for this program were provided by the School of Medicine, these awards are limited to junior faculty within the School of Medicine. As of January 2015, a total of 45 BERD Seeds had been awarded. Infrastructure for implementing and tracking research and services: OnCore, an electronic Clinical Trials Management System, was purchased in The plan is to gradually phase in the use of OnCore for new research protocols by different academic units or centers, starting with the Renal Division in the Department of Medicine and the Department of Orthopedics. The University of Colorado Comprehensive Cancer Center (UCCCC) is in the process of converting all active protocols to OnCore. The integration of OnCore with the UCH electronic medical record, the Institutional Review Board informatics system, and the university finance system is underway. As of January 2015, 5 new protocols were implemented under OnCore. Strengthen the NeTT: One goal for the NeTT was to implement a Core Laboratory Management System that would enhance efficiencies of operation for core laboratories and improve access to labs by investigators. We sought a webbased software platform that supports: management of facility details (e.g., description of resources), search Page -11-

12 capabilities (e.g., to help users find services), scheduling of services (e.g., reserve equipment or consultation time), management of workflow (e.g., tracking equipment usage), automated billing and invoicing (e.g., through direct link with institutional finance system), and reporting. In April 2014, the CCTSI and the UCCCC purchased a Core Laboratory Management System from ilab Solutions. The training and development phase for the first wave of 3 core laboratories started in September 2014 and they went live in January The second wave of 4 core laboratories is currently in the training and development phase. Over the next 1.5 years, there are plans to extend this to 18 to 20 core labs of the CCTSI and UCCC. The cost for the ongoing maintenance of ILab Solutions will be built into the service center per test charges to investigators. B3: What opportunities for training and professional development has the project provided? Such opportunities were not directly part of the overarching goals of the CTR R&S program. However, the MicroGrants and BERD Seed Programs foster the professional development of junior investigators by providing a source of funding for clinical research activities and biostatistics support early in their career. B4: How have results been disseminated to communities of interest? Nothing to report. B5: What is planned for the next reporting period to accomplish goals? Program Income System: We have one remaining critical step in the transition to a fee-for-service model and that is the implementation of charges for research nursing services. This is scheduled to start July 1, Charge masters have been developed for all of the CTRC units. This step represents a pivotal time for the CTRC Network because of the longstanding practice (40+ years of GCRC and CTRC units) of providing research nursing support for clinical investigations. This plan may have the unintended consequence of driving investigators to conduct their research outside of the CTRCs with personnel who may not necessarily have the same level of oversight for training and competencies. A goal of the CCTSI is to continue to develop a mechanism to subsidize research nursing support to make utilization of a central resource for conducting clinical research (the CTRC Network) cost-effective and attractive to investigators. The new FOA from NCATS challenges this notion for the future, such that we will be need to determine our best options as we approach our CTSA grant renewal in One potential plan for subsidizing CTRC nursing support is to expand the MicroGrants Program so that it is available not only to junior investigators but also to investigators who have federally sponsored projects that did not build the cost of nursing support into their grant budgets. Whether this can be carried out successfully will depend on the level of institutional support. Infrastructure for implementing and tracking research and services: The use of OnCore will be expanded to additional academic units and centers in the next grant year. A goal is to start using OnCore to define protocol recruitment targets and track the success of meeting the targets, as a means of identifying protocols that are in jeopardy of failing. Strengthen the NeTT: A major goal for the next grant period is to implement the ilab Core Laboratory Management System in more Network of Translational Technology laboratories, as outlined above. Another goal is to develop an Omics Working Group comprised of the directors and managers of the 5 genomics, proteomics, and metabolomics core laboratories supported by the NeTT. The short-term goal of the Working Group will be to facilitate the coordinated delivery of services to investigators. Longer-term goals are to match the capacities of the laboratories with the needs of investigators, capitalize on the unique strengths of each laboratory, minimize any duplication of services across laboratories unless there is sufficient demand, and maximize the utilization of current vs older generation technologies. Page -12-

13 Enhanced Research Environment (Regulatory Knowledge and Support Core): B1: What are the Major Goals: Promote a responsible and safe research environment across the lifespan of each study and improve the research enterprise to ensure a streamline, efficient and cost-effective system B1a: Have the Major Goals changed? No B2: What was accomplished? 1) Major Activities A single research web portal was established in late 2012 to serve as a centralized resource for researchers to connect to all the research administration resources on campus and within the affiliated institutions. It also is an easy point of contact for people in the community to access information about research at the university. The Clinical Research Support Center is now active and has been heavily utilized. The support center has worked to ensure compliance rate with CT.gov. The office has also facilitated applications to the FDA for IND and IDE applications. The education continues to be successful with RCR training and 13 other courses in human subject research on various topics from basic to advanced. The CCTSI Scientific Advisory Committee (SARC) has expanded its mandate and now serves as the scientific review committee for the institution. So that all protocols that meet the NIH definition of a clinical trial that have not been externally peer reviewed for scientific merit are now reviewed by SARC. As of August 4 th 2014, not only protocols using the CTRC units but all protocols that meet the criteria now undergo scientific review by SARC prior to submission to the IRB. A single portal for pre-irb submission to hospitals (Children s Hospital Colorado and University of Colorado Hospital) as well as all the CTRC units has been established and active since August This project is the first major initiative across the partner institutions relating to process consolidation for human subject research since the Colorado Multiple Institutional Review Board was established in 2000 to be the IRB of record for each of the partner institutions. The portal provides a single entry point into the pre-irb review process. It enables the institutions to evaluate the budget and feasibility of protocols while also reducing redundancy and improving efficiency. The process continues to be fine-tuned to further streamline and each institution has committed to further IT system integrations to further reduce duplication. Electronic protocol submission to IRB has been refined and structural changes within the office have led to an improvement in timelines. These process changes have led to further reductions in IRB approval times even with a consist increase in the number of research protocols being submitted for review. An electronic clinical trials management system (CTMS), OnCore has been purchased and configured. Limited integration has already been established between the CTMS and the electronic medical record system at University of Colorado Hospital. Further broader integration is scheduled for In addition, planning is in progress to integrate the CTMS with the IRB IT system and the university financial system, PeopleSoft. The main functionality of the system is now live and supporting protocols managed by the Department of Orthopedics and the Renal Division. The Cancer Center is scheduled to do a data conversion of all currently active studies in May At the same time as the Cancer Center goes live then the biospecimen module will be active. The plan to roll-out the system more broadly on the enterprise side is currently in development. Page -13-

14 The Research Ethics Core of the enhanced research environment component of the CCTSI held its annual Research Ethics Conference in October The conference was entitled Protecting Research Participatns Privacy: Is it possible? Should we care? The ethics consulting service now works closely with the Clinical Research Support Center and this relationship has led to more ethics consults as well as close collaboration on the RCR course. PACT Ethics Committee: This committee was established in 2013 but in the last year, it has increased its interaction with the clinical research community and proved to be a valuable resource assisting researchers to put together a community sensitive consultation plan for when consent is not viable in emergency settings. It is also working with researchers to develop recruitment material and facilitate recruitment outreach. 2) Specific Objectives The focus of the enhanced research arm of the CCTSI in 2014 has been on improving process to enhance efficiency and quality of all human subject research protocols developed and active at the University of Colorado Anschutz Medical Campus, the partner hospitals and the satellite CTRCs. 3) Significant results, including major findings, developments, or conclusions (both positive and negative) A single research web portal was established in late 2012 and is currently the 23 rd most visited page in the university web system. Clinical Research Support Center has worked to ensure that 98% compliance rate with CT.gov. The office has also facilitated applications to the FDA for IND and IDE applications. The education continues to be successful with over 100 post -doctoral students and faculty completing the RCR training. The support center offers 13 other courses in human subject research on various topics from basic to advanced. Each year there have been more than 300 employees who have participated in these classes. The CCTSI Scientific Advisory Committee (SARC) has reviewed 24 protocols since the change in process in August 2014 and of those protocols reviewed only 9 required scientific review that were not using CTRC resources. The single portal for pre-irb submission to hospitals (Children s Hospital Colorado and University of Colorado Hospital) as well as all the CTRC units has been established. Since the portal went live in August 2014, 362 protocols have been submitted and the average time to approval is 30 days. The process continues to be fine-tuned to further streamline and each institution has committed to further IT system integrations to further reduce duplication. Electronic protocol submission to IRB has led to a continued improvement in IRB timelines even with a consist increase in the number of research protocols being submitted for review. The number of protocols that require more than 2 reviews at committee remains high at approximately 30%. The aim of the revised pre-review process is to try to reduce that metric with a robust scientific review. OnCore, the electronic clinical trials management system (CTMS) currently has 5 protocols live in the system with a plan for broader implementation over the next year. The Research Ethics Core of the Enhanced Research Environment component of the CCTSI held its annual Research Ethics Conference in October The conference had 60 attendees which is consistent with previous years and the evaluation was that the conference was valuable. The ethics consulting service now works closely with the Clinical Research Support Center and this relationship has led to 6 ethics consults in the past year. Page -14-

15 PACT Ethics Committee: This committee has to date provided one consultation relating to waiver of consent in an emergency setting and reviewed the recruitment plan for 2 clinical trials. Metrics: The CCTSI continues to be challenged to collect metrics on the overall review process to approval for clinical trials. This is because various aspects of the approval process are contained in separate legal entities or separate IT systems that are not integrated. This is an important issue that remains to be addressed as it limits our ability to effectively use metrics to drive process improvement across the whole system. 4) Key outcomes or other achievements The first goal was to better integrate systems and processes that are involved in the evaluation of human subject research. This challenge was considerable given that the majority of research connects to a variety of institutions. The human subject portal is the first step towards integration. It currently focuses on the pre-irb review of protocols utilizing the CHCO, UCH, UCD and /or the CCTI CTRC units but the plan is to continue to broaden the scope to include the Denver VA and Denver Health and Hospital Authority in the next year. Already the integrated metrics indicate that there continues to be refinements necessary to the pre-review process across the institutions currently involved to further improve efficiency and reduce duplication. Feasibility and budget review is now possible due to the data that is provided by the research team as part of the pre-irb review process. SARC is providing feasibility and budget review for protocols seeking to use one of the CTRC units but also other protocols that have not received a scientific reviewed by an external body. Children s Hospital conducts a feasibility review of protocols using their facility and other research is evaluated by the university as part of its macro review. As the clinical trials management system is more broadly utilized then the integration of these protocols will be more easily facilitated. Tracking failing studies: Tracking of recruitment on the CCTSI research units is overseen by the Study Monitoring Committees (SMC). Now that the pre-review portal has been established and data is now readily available on the recruiting plan for each study then next step is to broaden the tracking of potentially failing studies. This process will be difficult until the CTMS system is more broadly implemented. Other plans to facilitate recruitment need to be developed over the next few years. The total time from submission to final approval and recruitment of first subject remains too long. Discussions continue to try to identify ways to reduce these broader timelines consistently for all research. B4: What opportunities for training and professional development has the project provided? An important component of the Research Environment focus is training on all aspects of human subject research. The Responsible Conduct of Research training course brings together clinical, animal and basic science researchers to discuss ethical and regulatory issues concerning research. The Clinical Research Support Center offers 13 different courses to train mainly research coordinators on the various complexities of conducting human subject research. The CCTSI has also participated in the grant supplemental to standardize the GCP training and develop management of competency training. B5: How have results been disseminated to communities of interest? Nothing to Report Page -15-

16 B6: What is planned for the next reporting period to accomplish goals? The Office of Grants and Contracts (OGC) has just instigated, in early 2015, a quality improvement evaluation using the QPIP resources of the CCTSI. This evaluation seeks to improve the internal efficiency and effectiveness of the office as well as strategically address integration with the pre-irb review process and CTMS implementation. The University continues to work towards closer integration of OGC, TTO and Regulatory Compliance Offices to provide more cohesive resources for investigators under the umbrella of Research Administration. Establishment of a single pre-irb review process facilitating coordination across the primary partner institutions is an important first step but now there needs to be a more robust integration of IT systems to reduce duplication and improve efficiencies. NCATS has established requirements for broader GCP training. In early 2015, the university will refine its existing policy relating to training requirements to comply with these broader GCP training requirements for all clinical trial personnel on campus. The broader adoption of OnCore as the CTMS across the research enterprise is necessary in order for the CCTSI and university to develop a standardized approach to identify failing studies on campus and develop a targeted approach to supporting struggling studies. The University in collaboration with its hospital affiliates is in the process of establishing a robust data warehouse. The Enhance Research Environment pillar is heavily involved in facilitating the regulatory components to enable this database to be developed and has begun to work with the business owners to establish an honest broker resource to enable access of de-identified and limited data set data for research purposes. Connected to the development of the Enterprise Data Warehouse (Health Data Compass) is an initiative at University of Colorado Hospital to establish a central DNA repository. This will be the first initiative at this hospital to try to facilitate a general research protocol across its organization. The plan is to assist in the development of this biobank and use the infrastructure developed to then facilitate a general recruitment registry for clinical research. Page -16-

17 NOTE: This summary is provided for EAC purposes only. The Research Studio Program will not have its own progress report in the CCTSI annual report. Highlights of this program are provided in the overall CCTSI Highlights & Milestones report. Research Studio Program Summary The Research Studio Program was established in the current CCTSI award, with leadership from Jane Reusch, MD and David West, PhD and programmatic responsibilities handled by Dan Holtrop. During the past year, the following has been accomplished: 1. Creation of program identity and development of marketing material. 2. Web enablement of key functions for the Research Studio program. 3. Evaluation methods and tools established. 4. Nine Studios sessions were held. 5. Two Studios recipients received external grant funding based on results from the Studio. (Armstrong and Linberg). 6. Upon Evaluation of the program, both experts and panelists rate their experience in participating in the Studios as being satisfied or highly satisfied and reported the experience was valuable. 7. Three Studio sessions are pending and or scheduled for January/February The Colorado School of Public Health and CSU have requested informational presentations regarding the program and several others units/divisions have expressed potential interest as well. Dr. Sokol will add description of this program to his Town Hall meetings to be scheduled in spring Over the next 12 months efforts will focus on expansion of Studios across all CCTSI partners, marketing the program more broadly, thorough evaluation of results of the program, and determining alternative funding sources for sustainability of the program. We will also address any of the following questions that did not receive strongly agree or agree from all participants. Studio Session Evaluations Composite Responses A. Investigator Evaluations: (n=6) For questions 1-8 Strongly Agree = 37, Agree=6, Neutral = 0, Disagree=2, Strongly Disagree = 0 1. Scheduling and communications handled efficiently 2. Moderator managed time effectively 3. Studio was adequate length 4. Experts were relevant 5. I was satisfied with the session 6. Studio process was worth my time 7. Feedback was appropriately conveyed 8. Studio improved the quality of my project Page -17-

18 For Questions 9-12 Yes = 21, No =3 9. Recommend session to others? 10. Would you request a future Studio? 11. Would you be an expert in a Studio? 12. Would you request services again from individual participating in this Studio? B. Expert Panelist Evaluations: (n=18) For Question 1-8 Strongly Agree = 96, Agree = 47, Neutral =1, Disagree =1, Strongly Disagree=0 1. I had relevant experience 2. Moderator managed time 3. Process was worth my time 4. Scheduling was handled in a timely manner 5. Studio improved the science of the project 6. Length of the Studio was adequate 7. Investigator was prepared 8. I was able to provide substantive contribution For Question 9 and 10 Yes = 35, No = 1 9. Would expert be willing to provide additional consultation to investigator? 10. Would expert be willing to participate in future Studios? Page -18-

19 Quality and Process Improvement Program (QPIP) B1: What are the Major Goals: Aim 1: Identify and remove obstacles to efficiency and process improvement in priority areas Aim 2: Form clearly identified and empowered process improvement teams Aim 3: Link with evaluators to ensure efforts are complementary rather than redundant Aim 4: Integrate quality and process improvement into CCTSI governance and decision-making structures B1a: Have the Major Goals changed?: No B2: What was accomplished? In an effort to improve the efficiency and coordination of research protocol review and approval and shorten the time to approval, the QPIP team engaged with Alison Lakin and her staff in the Enhanced Research Environment Pillar Program in a comprehensive review and redesign of the Pre-IRB Review Process utilized for research conducted on the Anschutz campus, with specific emphasis upon non-industry (e.g., NIHfunded) research. The effort had a goal of producing a: Unified Pre-IRB review process for CHCO, UCH, SARC, and UCD Single port of entry for all investigators Single approval letter for all protocols Tracking system (automated), and the use of metrics to identify performance of each partner, and sub process The revised process (entitled the Human Subjects Research Portal went live 8/14/2014 ( and has dramatically changed the process for research protocol submission and review at UC Denver. The QPIP team has now begun work with Nichole Carlson, Director of the BERD Core Program, to analyze and redesign key processes associated with the use of the BERD for biostatistical support by CCTSI member faculty and trainees, with the goal of improving efficiency, financial sustainability and user satisfaction of BERD services and collaborations. B4: What opportunities for training and professional development has the project provided? Nothing to Report B5: How have results been disseminated to communities of interest? Nothing to Report B6: What is planned for the next reporting period to accomplish goals? The QPIP team will continue to work with Nichole Carlson, Director of the BERD Core Program, and her team to analyze and redesign key processes associated with the use of the BERD for biostatistical support by CCTSI member faculty and trainees, with the goal of improving efficiency, financial sustainability and user satisfaction of BERD services and collaborations. If this is completed during the next grant period, then the QPIP team will begin to examine some of our educational programs. Page -19-

20 Pragmatic Trials and Dissemination/Implementation Research Unit Section B: B1: What are the Major Goals: 1. To foster a learning community and serve as a conduit for active dissemination of resources from NIH and other national organizations engaged in implementation science and pragmatic research. 2. To catalyze and centrally support the CCTSI community in the development of pragmatic trials, comparative effectiveness research methods, and implementation science to achieve increased efficiency and economies of scale. B1a: Have the Major Goals changed? No B2: What was accomplished? To foster a learning community, a Pragmatic Trial Training Workshop was developed in partnership with the UC Denver Center for Research in Implementation Science and Prevention (CRISP) (AHRQ grant number P01 HS021138, PI=Kempe). Outside guest experts from PCORI and the University of Maryland, and the University of Illinois Chicago CTSAs contributed to the instruction. Eighty-three faculty, research staff, and students attended; 91% of participants strongly agreed/agreed that they were satisfied with workshop. In addition, a monthly seminar series on implementation science and pragmatic trial research was directed averaging participants per month. To catalyze and centrally support the CCTSI community a new Pragmatic Trials and D/I webpage of national resources were developed and launched. B4: What opportunities for training and professional development has the project provided? A new graduate course (Dissemination and Implementation Research in Health, CLSC 7653) was developed for the CCTSI Clinical Science Graduate Program using resources and expertise from the Pragmatic Trial and D/I unit. In addition, professional consultation on individual dissemination and implementation science projects was also provided via the CCTSI K-to-R program and other interactions.. B5: How have results been disseminated to communities of interest? Training materials were archived on an open-access web portal ( An on-line interactive ebook website was also developed (see: and disseminated to the former CTSA Comparative Effectiveness Research Key Function Committee membership and nationally through the Implementation Network Newsletter, the NCI Cancer Control and Population Sciences Newsletter, and the KT (Knowledge Transfer) Canada Newsletter. Findings were presented scientifically at the NIH-Academy Health 7 th Annual Conference on the Science of Dissemination and Implementation. B6: What is planned for the next reporting period to accomplish goals? Training materials from the Pragmatic Trials Training Workshop will be published as an interactive ebook website. A training workshop is being planned for academic year 2015/2016 on the topic of pragmatic research methods using electronic health data. A conference to establish a national implementation science research agenda on the appropriate use of clinical preventive services will be co-hosted by the CCTSI (AHRQ grant number R13 HS , PI=Morrato). Page -20-

21 Clinical and Translational Research Center (CTRC) Network B1. What are the Major Goals? The goal of the CTRC Network is to integrate, transform, and expand services, both within and across CTRC units, and to provide a maximally supportive environment for expanded and advanced clinical translational research. Overarching goals of the R&S pillar program that guide the activities of the CTRC Network include: Develop and implement a Program Income System and an evaluative process for cost-effective allocation of resources that support planning, conduct, analysis, and dissemination of research results. Optimize the infrastructure for implementing and tracking R&S services. Provide a network of services to support investigators in designing, conducting and disseminating the highest quality research. B1a. Have the Major Goals changed? No B2. What was accomplished? B2.1. Major Activities The organizational structure of the CTRC Network includes a Scientific Advisory & Review Committee (SARC). The SARC panels review the science of studies desiring access to any of the services of the five CTRCs (CHCO, UCH, NJH, Perinatal, and CU-B), and also provide scientific reviews for any clinical protocol that has not undergone peer review of scientific merit. In the last grant year (year 6), a total of 136 new protocol applications were reviewed. It is projected that a total of 113 new protocols will be reviewed in grant year 7. Research Subject Advocates and Navigators review protocols for safety and assist with IRB submissions. In the past grant year, the Research Nursing Cores at UCH, CHCO, Perinatal, and NJH collaborated to develop comprehensive charge master templates (Section B2.3). These will be used for the final transition to a fee-for-service model for research nursing services, which will occur July B2.2. Specific Objectives: Specific goals of the current grant year included: Carry out the 2 nd phase of the transition to a fee-for-service model (i.e., for Nutrition services) for the CTRC Network that was planned for year 2 Initiate the implementation of a Core Laboratory Management System (ilabs) for the CTRCs Streamline and integrate with the hospitals and COMIRB the process for reviewing CTRC protocol submissions Continue to support a broad spectrum of clinical and translational research B2.3. Key achievements: Program Income System: A program income system (PIS) was fully implemented for the Pediatric and adult core labs in The PIS for the Nutrition Core is complete and will be implemented as soon as integration into UCD financial processes is achieved (expected implementation date 3/1/15). The Nursing Cores at UCH, CHCO, NJH, and UCB have developed complete charge masters which will be implemented on July 1, Investigators at UCH and CHCO (including Perinatal) can currently plan budgets for future studies based on pricing available on the CCTSI website. Previously, these budgets were prepared by CCTSI administrative staff for each investigator who requested services for a protocol or grant application via . Providing real time, transparent pricing information expedites the process of budget planning for new protocols and grant applications, thereby increasing efficiency, and expands the visibility of our services to other, non-ctrc investigators who might benefit from use of these resources. Tracking R&S services/streamlining the process for reviewing CTRC protocols: In 2014, UCD implemented the Human Subject Research Portal (HSRPortal). The HSRPortal is the one point of entry for all non-exempt IRB protocols on the UCB Anschutz Medical Campus, including all CTRC protocols. Protocols are automatically routed by the Portal through the correct process regardless of where the work will be conducted and insures that all review committees are viewing and approving the same version of the protocol. This system prevents protocols from entering the scientific/irb processes at different stages and increases efficiency for investigators and reviewers. In addition, as part of the Portal workflow, all new non-exempt protocols that have not received external peer review are reviewed by SARC prior to IRB review/approval. SARC has provided review and feed-back for nine such non-ctrc studies to date. To effectively and efficiently handle this increased demand for review, SARC added two new co-chairs in 2014 to expand the expertise of the Chairs and add Pediatric Chairs. Page -21-

22 The IT and workflow processes for the HSRPortal application were developed in a joint operation by UCD Regulatory and Compliance, the CCTSI Regulatory Knowledge and Support Core, the CCTSI Translational Informatics Core, and CCTSI QPIP with site-specific workflow information and processes provided by CHCO and UCH. Implementation of a Core Laboratory Management System: The adult and Pediatric Core laboratories were in the first wave of Cores to implement ilab Solutions for tracking and automated billing of services. ilab Solutions software was obtained and implemented by the CCTSI and UCCC. The CTRC Core Laboratories went live on the platform on January 5, This software is expected to increase the efficiency of billing of services and will allow for more automated tracking and provision of metrics. Provide a network of services to support investigators in designing, conducting and disseminating the highest quality research: All CTRC services including RSA, Navigator, Nursing, Nutrition, and Core Laboratory have been well utilized in the current grant year as evidenced by the metrics shown below. Figures 1-4 generally show decreasing utilization over course of this grant cycle with stabilization over the last two years. To accommodate this decline in activity both the UCH Core Laboratory and nutrition Core have halved their FTEs over the last 2.5 years. Staffing of these Cores is now at a level that should be sustainable if utilization has stabilized, as expected. Figure 1. Total outpatient visits at each CTRC site per grant year. All 7 years of the grant period are shown. CTO, Clinical Trials Organization studies (industry funding). Utilization has decreased at UCH overall with a nadir in year 5. Utilization in years 6 and 7 has stabilized and is still robust. Figure 2. Total inpatient visits at UCH and CHCO CTRCs site per grant year. Only the UCH and CHCO sites offer inpatient facilities. All 7 years of the grant period are shown. Over the last 2-3 years, inpatient operations at both sites have changed to accommodate lower utilization of this resource. At UCH, in response to utilization, the inpatient unit was decreased in size which resulted in an overall decrease in rent. At CHCO, the inpatient unit changed from a dedicated CTRC unit to flex space within a clinical unit. This model facilitates more efficient staffing as the CTRC does not need to staff an inpatient unit full time and those staff can be reassigned to outpatient activities in real time. CHCO utilization has increased the last two years. Page -22-

23 Figure 3. Total number of assays performed at CTRC Core Laboratories. There is no duplication in services provided between labs so these numbers represent unique assays performed. These assays supported a total of 194 protocols in year 6 and 203 protocols in year 7. Similar to inpatient and outpatient activity, the Core labs have observed a decrease in utilization over time which has stabilized in years 6 and 7. This is most likely a result of switching to a fee-for-service model. Figure 4. Nutrition Core utilization. Nutrition Core services are available at UCH and CHCO CTRCs. Total hours provided indicates the total number of staff hours provided for all Core activities, including metabolic diet design, weighing, and dispensation, food weigh-backs, data entry, anthropometric measurements, dietary intake questionnaires, food design for new studies, etc. Although utilization decreased from year 4 to 5, it has stabilized the last two years. B4: What opportunities for training and professional development has the project provided? Although this is not a specific goal of this Program, several of the CTRC Cores and staff are involved in training future clinical researchers. The Nutrition Core oversees an approved rotation for Dietetic Interns who are part of accredited Academy of Nutrition and Dietetics (AND) Internship programs. Completion of an AND Dietetic Internship is required to obtain an RD qualification. Thus, the Nutrition Core is involved in the training of future health care and research professionals. In addition, the RSA and navigator provide regulatory support and training to junior investigators. The UCH Nursing Director teaches at monthly campus-wide Clinical Research Training events that are organized by UCD Clinical Research Support Services. B5: How have results been disseminated to communities of interest? Nothing to report B6: What is planned for the next reporting period to accomplish goals? Program Income System: The nursing core will implement charge-backs for services beginning July 1, We will be examining the effect of this closely on utilization and investigator usage of CTRCs, as well as utilization of the MicroGrants by junior investigators to offset these costs. ilab Solutions: The Nutrition Core will implement ilab Solutions as its tracking and billing platform in Summer, HSR Portal: CTRC and SARC staff will continue to work with other CCTSI Cores, UCD Regulatory Compliance, and UCH and CHCO management to further streamline the process of protocol review and approval with a view to reducing the total time taken from protocol submission to approval. Page -23-

24 Biostatistics, Epidemiology and Research Design (BERD) B.1: What are the major goals? Aim 1: Biostatistics Consultation and Collaboration with Clinical and Translational Scientists Aim 2: Develop a reproducible research platform Aim 3: Advance biostatistics and epidemiological methods for translational research. Education and Training B.1a: Have the Major Goals changed? No B.2: What was accomplished? B.2a: Consultation/collaboration (Aim 1) The BERD has fully implemented a program income system and diversified its expertise to include microbiome and genomics. The program income system is implemented through the Colorado Biostatistics Consortium (CBC) and the Children s Hospital Colorado Research Institute Biostatistics Core (CHCO). We can now account for what portion of the hourly cost of biostatistics support is supported by the BERD grant. For example, the BERD contribution to the director and administrative assistant s FTE covers approximately 17% of the hourly cost of biostatistics for the entire campus. Additional FTE directly supported by the BERD covers an additional 75% of the cost of biostatistics for CCTSI members such that the hourly rate for charging for biostatistical consult services is approximately $35/hr. To further facilitate the development of junior researchers, the School of Medicine provides an additional $25K of matching funds to subsidize the $35/hr rate (BERDSeeds). In summary, in the past year we have successfully implemented a cost effective and transparent program income system to maintain a robust collaborative biostatistics infrastructure for CCTSI members. We responded to user requests to have more expertise in new translational analysis methods. We have 0.1FTE of a PhD biostatistician who is an expert in analysis of microbiome and omics and have 0.25FTE of a graduate student apprentice receiving training to perform small RNA-seq analyses along with other omics methods. B.2b: Reproducible Research (Aim 2) We have implemented a consistent and secure file storage system for BERD projects and the CCTSI Informatics program is creating a web portal for secure transfer of data to the BERD program and sharing of analysis reports and publications. B.2c: Biostatistics methods research (Aim 3) The BERD biostatisticians have research expertise in Bayesian methods, microbiome, imaging methods, and structure equation modeling among others. We continue to develop new statistical methods for problems arising out of BERD requests. B.2d: Organizational characteristics The BERD leadership is tightly integrated with the Department of Biostatistics and Informatics and the CBC, the other major campus wide biostatistics resource. All CBC and CHCO-RI biostatisticians also are part of the BERD. Between the CBC and RI there are ~6.8 faculty and student FTE dedicated to meeting CCTSI member and campus biostatistics needs (3.6 FTE CCTSI grant support and additional cost sharing). The BERD also supports 0.5 FTE for protocol review and education offerings. The BERD director receives 0.4 FTE. B.2e: Progress, Opportunities, Challenges, Strengths, Weaknesses and Modifications Opportunities The University of Colorado School of Medicine has just recruited a new Dean. This is an opportunity to further clarify the role institutional support plays in maintaining a robust and comprehensive biostatistics resource that will be sustainable for clinical and translational Page -24-

25 researchers. We are in the process of adopting ilabs for project registration and billing. This gives us an opportunity to develop more efficient administrative and collaborative processes. Challenges Maintaining and growing collaborative support as the BERD CCTSI budget declines is a challenge. We will need to cost shift to School, Depts and individuals in the right balance to not become cost prohibitive. We are creating a new business model for campus wide biostatistics to help justify the need for Dept and School resources. Strengths The BERD in collaboration with the CBC and RI has developed a strong and visible biostatistics infrastructure for the AMC campus. This will aid in being able to implement the program income system and to maintain investigator access to a wide range of biostatistics expertise. Weaknesses The additional institutional resources for biostatistics and the BERD are under financial pressure. Thus the BERD cannot provide unlimited support for all investigators. Modifications The focus of Aim 1 (consultation and collaboration) in the application was on new multicenter trial resources. This goal for AMC has since been assumed by the Colorado Prevention Center. Thus, we are focusing our Aim 1 on developing capacity and streamlining data processes for big data methods needed extensively in translational research. B.2f: Major Accomplishments and Impact (related to one or more goals) The CBC initiated 137 projects (78 of them received the direct CCTSI subsidy). We continue to be a broad resource collaborating with over 22 departments and all schools on our campus. Approximately 70% of our users are junior faculty and were awarded all of the SOM matching money. SOM is considering adding additional resources to further support free CCTSI support for junior faculty. 41% involved study design and sample size calculations. The rest were data analysis for abstracts and publications. The CHCO biostatistics group initiated 82 projects for 22 divisions in the Department of Pediatrics. All users are CCTSI members. A similar proportion of projects were for junior faculty. B4: What opportunities for training and professional development has the project provided? We continue to offer a 6 week biostatistics short course for non-biostatisticians to approximately 30 AMC employees (Oct 2014). We completed our monthly STATS101 seminar series. We have developed a new biostatistics boot camp course where registrants attend 4-2 hour hands on sessions focused on analyzing different sets of data. B5: How have results been disseminated to communities of interest? Nothing to report B6: What is planned for the next reporting period to accomplish goals? To continue to develop a comprehensive biostatistics support model to maintain a high quality and low cost (to the individual) focused on developing new collaborative teams. We have started a Quality Process Improvement plan with the CCTSI QPIP core. We are focused on improvement in project initiation and completion, more efficient marketing of our resources and prioritization of our resource, and improving the biostatistician-investigator matching to increase the formation of collaborative research teams involving biostatistics. To transition all BERD users to the new ilabs system and portal. Page -25-

26 Community Engagement & Research (CE&R) B1: What are the Major Goals: (list component Specific Aims 1) The Community Engagement Core (CE Core) elevates patient-centered, practice-based and communityengaged research throughout the translational research spectrum from T1 to T4; strengthening the bidirectional links between the academic medical center, healthcare providers, and community members to provide the right care, to the right patient, at the right time. 2) Through a robust resource portfolio, the CE Core provides a multitude of services including: training, community liaison services, pilot funding, consultation, technical assistance, and mentoring to increase the workforce and build the capacity of Colorado researchers, community organizations and practices to conduct mutually beneficial, community-engaged research, 3) The CE Core works with communities and providers to transform evidence-based recommendations into language and programs that are accessible to the diverse communities in Colorado, thereby increasing uptake of those recommendations and improving patient outcomes. B1a: Have the Major Goals changed? No B2: What was accomplished? 1) Major Activities: 1. Supporting and strengthening strategic community-academic partnerships to facilitate quality community-engaged research: PACT: The Partnership of Academicians and Communities for Translation (PACT) is a statewide collaborative of academic researchers, communitybased organizations and individuals, and healthcare provider networks working together to provide a platform for guiding our innovation and excellence in community engagement. Community Research Liaisons (CRLs): The CE&R Core currently provides funding and support for 11 CRLs (4 FTE) working in diverse communities in urban and rural Colorado. CRLs cultivate relationships between academic researchers and individuals within a population, identifying community health priorities and helping to design locally relevant studies and programs that address community, patient and provider needs. CRLs are also heavily involved in developing and delivering core programming. Colorado Foundation for Public Health and the Environment (CFPHE). CFPHE is a strategic community partner and integral component of the CE&R Core, working in tandem with the university and CCTSI to surmount the social, ethical and administrative challenges inherent in operationalizing community-engaged research and programmatic partnerships. CFPHE serves as an administrative and programmatic liaison between the University, Community and funding agencies to create efficiencies in the distribution of funding, technical assistance and other resources to community-based partners. 2. Improving the institutional environment to support community engaged research: The CE Core provides community engagement expertise in training, community research liaison services, pilot grant funding, consultation, technical assistance, and mentoring to increase the research workforce and build the capacity of researchers, community organizations and clinical practices to conduct communityengaged research studies. Improving Research Through Community-Academic Partnerships: Pilot Grant Program i : The CE Core Pilot Grant Program supports community-academic partnerships to perform pilot studies that will strengthen relationships and produce preliminary data for future competitive translational research grant applications. Funded projects encompass partnership development, project planning, capacity building (i.e., data collection and management, recruitment and outreach, etc.) as well as implementation of research projects within specified areas of emphasis (cardiovascular disease, childhood chronic conditions, social emotional health). The development of innovative interventions or the adaptation and implementation of existing advances within the community setting is the expected long-term outcome. Let s Get Started Training for Community-Academic Research Partnerships: The CE Core provides in-depth training for pilot awardees and others in the principles of CBPR. The training includes a 4-hour didactic seminar followed by an additional 4 hours of one-on-one CBPR coaching support throughout 12-month pilot award. The Colorado Immersion Training in Community Engagement (CIT). CIT is a unique community-campus educational initiative that aims to introduce an expanded pool of researchers to community-based participatory research (CBPR) and community engagement. The program occurs annually on campus and in six community settings: urban African American, urban Asian and Refugee, urban Latino, urban American Indian/Alaska Native, rural northeast Colorado, and rural San Luis Valley. Components include a four-week Directed Reading, Seminar on CBPR, four-day immersion experience living in the target community, structured mentoring, and follow-up. Page -26-

27 Academic Immersion brings community members to the biomedical research complex for a one-week intensive that includes meetings with investigators, research staff, faculty and administrators, and tours of University labs and research facilities. This experience increases understanding about the research process and helps to build trust between the University and the Community. One-day Immersion field experience. The field experience was designed as an introduction to CBPR and community engagement for masters-level students in the School of Public Health. Community Liaisons accompany groups of students into the community to expose them to local customs, events and community leaders. Research through Community-Academic Partnerships: Lessons Learned is a seminar series that provides practical training for engaging in community-academic research partnerships. Community and academic investigators conduct the seminars and present their own experiences as case studies in CBPR. Community Liaison Curriculum: The CE Core is currently developing a comprehensive training program designed for our Community Research Liaisons, which includes courses on clinical trials participation, research ethics in community engaged research and qualitative research methods. These courses are intended to provide Liaisons with the skills and information necessary to participate in research and to educate their constituents about the benefits of research. 3. Translating and disseminating scientific discoveries into practical, community-relevant language and interventions: Boot Camp Translation for Patient Centered Outcomes. The CE Core provides an innovative tool for communities to translate evidence-based recommendations into language and programs accessible by the diverse communities in Colorado to increase the uptake and implementation of evidence-based recommendations and improve patient outcomes. Boot Camp Translation (BCT) for Patient Centered Outcomes was successfully pilot tested in rural Colorado and now is being used in additional PACT communities throughout the region. Boot Camp Translation addresses the core concepts of the CTSA by translating medical evidence into communities for rapid and efficient implementation and dissemination. 4. Strengthening the bidirectional links between the academic medical center, healthcare providers, and community members: Practice-Based Research Networks (PBRN s). The CE&R Core has spent the past year working to build relationships with Colorado s robust PBRN s. PBRNs support clinicians and practices working together with academic researchers to develop research questions and design and conduct studies in pragmatic, real-life clinical practice settings, giving practitioners experience in clinical and health services research, while at the same time enhancing the research topics through local relevance and innovation. Engaging Communities in Education & Research. Engaging Communities in Education and Research (ECER) is a two and a half day conference held in Vail, Colorado aimed at bringing rural and urban underserved community members and inter-professional health care providers together with academic educators and researchers and community-based organizations committed to improving the health of all Colorado. ECER is a successful collaboration with over 500 attendees among the CCTSI CE Core, Colorado Area Health Education Center (AHEC), and the Shared Network of Collaborative Ambulatory Practices and Partners (SNOCAP) Colorado s practice-based research collaborative and the Schools on the Anschutz Medical Campus. The PACT Council holds its annual retreat on the day prior to the conference. 5. Infusing community engagement throughout the translational research spectrum: Community Consults: This new initiative was launched in year 1 in an effort to infuse community input into the early design of T1-T2 clinical research. The CTRC medical directors will identify and invite participation of PIs (including KL2 awardees) who are proposing investigator-initiated CTRC projects. The CE&R Director, PACT Council, and Community Liaisons will assemble 6 to 10 community members or patients whose interests are aligned with the proposed research. The PI will provide an overview of the research field and community members will provide feedback about the value of the research to their community, suggestions about patient-centered outcomes that would have meaning to them, comments on study design, ways to make the study more attractive to participants, and ethical concerns. We have piloted this program with several investigators and are moving to advertise it s availability more broadly. 2) Specific Objectives: a) Support and strengthening strategic community-academic partnerships to facilitate quality community-engaged research; b) Improve the institutional environment to support community engaged research; c) Facilitate the translation and dissemination of scientific discoveries into practical, community-relevant language and interventions; d) Strengthen the bidirectional links between the academic medical center, healthcare providers, and community members; e) Infuse community engagement throughout the translational research spectrum. Page -27-

28 3) Significant results, including major findings, developments, or conclusions (both positive and negative) For the first time since the program s inception, we have had to decrease the size of the PACT Council due to budgetary constraints. We are actively working with the Council to develop a plan to deal with future funding reductions. The Community Consults program has been challenging to implement in the T1-T2 space. However, we have received many inquiries from investigators who are eager for consults related to conducting patient centered outcomes research. We are exploring the viability of creating a consultation service for this purpose. 4) Key outcomes or other achievements: Throughout the funding period, the CE&R Core has continued to support the PACT and its governing board, the PACT Council, evaluating our work, refining our aims, developing metrics, strengthening our infrastructure and improving the programs and services we provide. The PACT Council meets as a group bi-monthly. Additionally, PACT Council members participate in a variety of workgroups that support the CE&R Core s projects, programs and resources. We have conducted two community consults that were well received by investigators and community members alike. More than 1500 people have participated in the ECER Conference the past four years representing all regions of Colorado and new and strengthened collaborations have grown and developed into significant programs and research projects in rural and urban underserved communities throughout Colorado. ECER is an example of how several separate, but related groups, can provide a new venue for increasing community engagement and collaboration to improve the health of the state through education, training, research, partnership, and communication. Our innovative partnership with CFPHE has greatly improved the CE&R Core s ability to respond to community administrative needs and has been presented at several national conferences. It has also gained the recognition of PCORI as a model for their own community pipeline awards program. The Shared Network of Colorado Ambulatory Practices & Partners (SNOCAP), which is directed by the CE&R Engagement Director, has become a close collaborator in the CE&R Core s efforts to reach the provider population and to examine the benefit of community engagement in practice-based research. We have begun to link the infrastructure of the two programs, investing in two shared staff positions and submitting a $15 Million grant proposal to AHRQ. Fernando Pineda-Reyes, the Vice Chair of the PACT Council and CEO and Founder of CREA Results (Community Research Education & Awareness), was appointed to the National Center for Advancing Translational Sciences (NCATS) Advisory Council Working Group on the Institute of Medicine's (IOM) Clinical & Translational Science Award Program Report. He was the only community representative on this NIH advisory council. Fernando has served on the planning committee for all three National Community Partner Forums on Community-Engaged Research and has served on the PACT council for the Community Engagement Core of the CCTSI since its inception. We have started a discussion with our IRB regarding barriers to community members participating in research (i.e., community advisory council of the High Plains Research Network) having to go through the same research group training as academic researchers. COMIRB is considering relaxing some of their requirements for community members in the near future, and sharing with other IRBs as a model. Our pilot grant program continues to yield valuable community engaged research projects that go on to procure national recognition in publications and large grants from extramural funders. For example, a pilot grant project on Hands-Free CPR was recently published in the Annals of Emergency Medicine ii and launched a website in partnership with the American Heart Association. This is the first paper ever written on this topic, in a journal that RARELY publishes qualitative work. This foundational work will provide the framework for a national program targeting decreasing health inequities in cardiac arrest. B4: What opportunities for training and professional development has the project provided? Introduction to CBPR for Community-Academic Partnerships Colorado Immersion Training in Community Engagement Research through Community-Academic Partnerships: Lessons Learned Boot Camp Translation for Patient-Centered Outcomes: Facilitator Training Engaging Communities in Education and Research (ECER) Annual Conference Page -28-

29 Boot Camp Translation for Patient-Centered Outcomes: Facilitator Training B5: How have results been disseminated to communities of interest? We have disseminated program and pilot grant results through normal academic channels (i.e. presentations at local, regional and national meetings, publications). We have also supported community-based dissemination efforts for our pilot awardees. We send out a bi-weekly newsletter to our community and academic partners with key results and relevant information. We reach out to communities around the state through our PACT partnerships and assist CBO s in their efforts to apply for grant funding related to translation and dissemination activities. B6: What is planned for the next reporting period to accomplish goals? We plan to continue our efforts in the areas described above with an emphasis on improving the Community Consults program and developing the community research liaison curriculum. We are also working closely with the PACT Council to examine opportunities for diversified funding streams, program income and sustainability. i Main, DS, Feltzien MC, Magid DJ, Calonge BN, O'Brien RA, Kempe A, Nearing K. A community translational research pilot grants program to facilitate community-academic partnerships: Lessons from Colorado's CTSA. (In Press). In forthcoming special issue, Science of Community Engagement: Progress in Community Health Partnerships: Research, Education, and Action. ii Only-CPR-Program_UCM_470204_SubHomePage.jsp Page -29-

30 Child and Maternal Health (CMH) Research Program Section B: B1: What are the Major Goals: The goals of the CMH Research Program remain unchanged: The CMH program raises awareness of: CMH investigators within the CCTSI of ongoing CMH research; Mechanisms for assistance to participate and succeed; Pilot grant opportunities; Potential collaborations with on-going research programs and CMH Working Group initiatives. The CMH Research Program emphasizes the maternal-infant dyad, but all aspects of child health (pediatric) and pregnancy-related research are included, encouraging expansion into life course research. B1a: Have the Major Goals changed? No B2: What was accomplished? 1) Pilot Projects: The CMH Pediatric Oversight Committee reviewed 24 pilot grant applications for 2015; as of now, 5 will be funded for a total of $100,000: 2) Pregnancy Research a) The Perinatal CTRC Triage Committee (PCTC) and the Perinatal CTRC Research Facilitation Committee (PRFC) assist investigators in accessing perinatal research populations of pregnant mothers, early and late preterm infants, and cord blood for immediate assays and biobanking. The PRFC established policies and priorities for accessing these scarce populations and for adjudicating conflicts. The Triage Committee, chaired for now by John Kinsella MD, reviews new projects and recommends ways to accommodate them amidst research currently underway. The PRFC adjudicates project activation when complex issues are involved, as well as recommending policies and practices for review by the CMH POC. The Triage Committee continues its work; the PRFC, as noted, will be reconfigured to reflect needs of all investigators (faculty and trainees) who are members of the CCTSI. 3) Neonatology Clinical Translational Research Task Force and Working Group a) Dr. John Kinsella (Neonatologist) continues as Director of the Neonatology Working Group and Co- Director of the CMH Program. He also is active in the PCTRC and PRFC. b) Dr. Kinsella continues to lead the Neonatology Working Group of neonatologists involved in C-T, QI, and translational science research (Theresa Grover, Jim Barry, Laura Brown, Regina Reynolds, Susan Niermeyer, Clyde Wright, Jason Gien) to assist with study design and resource allocation. 4) Perinatal Clinical Translational Research Center Activity: a) The Perinatal CTRC (W Hay, Figure 1: Perinatal unit activity by year Director) provides perinatal research nurse support for 27 protocols in seven units at three hospitals. b) Neonatal intensive care unit (NICU) and Labor & Delivery experienced nurses provide expert clinical research support during protocol development, implementation, and data collection c) Provide specialized NICU research nursing care (UCH, CHCO, St. Joseph s Hospital NICU) a. Study recruitment Visits Hour Page -30-

31 b. PeaPod (including weekends!), Bayley evaluations, NICU nursing care, medication administration c. Study implementation with follow-up in the neonatal population 1-2 times/week up to discharge d. Data collection & data entry e. Screen Labor & Delivery for pre-consented patients from clinic i. collect and process cord bloods and placentas f. Approach families at extremely vulnerable times for study enrolment very skilled at this difficult task! d) Use of non-nurse Professional Research Assistants (PRAs) to assist with protocol implementation a. Increased responsibility of PRAs within their scope of practice e) Liaisons to PIs (functioning as Co-Is or Research Coordinators on certain studies) a. Set up protocols b. Write guidelines & orders c. Assist with COMIRB renewals/approvals d. Troubleshoot nearly all problems e. Provide education to clinical staff f. Monitor patients enrolled in long term studies f) The staffing increased to 7.1 from 5.4 FTEs. A Program Coordinator was added to support the business of the Perinatal CTRC unit in anticipation of the subsidized fee for service model. a. The Perinatal CTRC is fully staffed with five Registered Nurses (RNs) including the Clinical Lead, two PRAs, and one Program Coordinator. b. RNs maintain clinical acumen by staffing in the NICU. c. Increase PRA FTEs to offset non RN tasks g) Multiple protocols recruiting from a limited but highly sought after population are successfully managed. Activity levels have recently trended downward from peak in 2011 as a result of less time intensive L&D studies, changes in enrollment criteria, and completion of NICU protocols. Decreased activity also is a result of protocol overlap (MFMRU competition). h) Of major note, Perinatal CTRC activity is not always captured as a visit; a large part of the work is in the form of indirect nursing activities that support studies, i.e., protocol development, facilitation, and management, as well as education of and coordination among clinical and research staff. i) Cord blood and placental/cord collections are among the most difficult of L&D protocols. Of all L&D admissions, 24% are eligible and 34% of those are enrolled with a collection rate of 80%. Overall, the Perinatal CTRC had contact with 60% of all eligible patients on L&D. 5) Development of Colorado Institute for Maternal and Fetal Medicine (CIMFM) at CHCO, UCH, and UCD: From its inception, the CMH research program has supported the development of a Maternal-Fetal- Neonatal Care clinical service at CHCO (in collaboration with UC Hospital [UCH] and UCD) to provide new research opportunities in pregnancy, fetal, L&D, and neonatal patients. This has come to fruition with the CIMFM, created as a joint venture between UCH and CHC. Recruitment of more MFM faculty is underway to expand fetal research. 6) New COMIRB Panel: New COMIRB panel continues to help address growing interest in child and pregnancy health research. Current efforts are underway to ensure that all child-maternal health protocols are reviewed by one committee, whose membership includes individuals with significant expertise and experience in this area of research. B4: What opportunities for training and professional development has the project provided?: Trainees continue to be involved in CMH research protocols, and thus benefit from the facilitation and services offered by the research nursing personnel. B5: How have results been disseminated to communities of interest?: Nothing to Report Page -31-

32 B6: What is planned for the next reporting period to accomplish goals? Fill vacancies: administrative/leadership roles: L&D Co-Director, Research Advocate, Perinatal CTRC Research Manager. Expand CMH POC to include representatives from School Public Health (Dana Dabelea, past member), College of Nursing (Nancy Lowe and Bonnie Ganz-Cleveland, current members), School of Dentistry (currently no members), School of Pharmaceutical Sciences and Pharmacy (currently no members). Establish adequate Perinatal CTRC office and lab space within the UCH and CHCO NICUs. Expand/Stabilize Perinatal CTRC Research Nursing Support; include more PRAs and other sites; shift burdensome night/weekend call to others. Under the new Perinatal CTRC management, develop new organization and rewards that will help increase recruitment and retention of RNs and PRAs. CMH Pilot Grant Program develop new approaches to encourage larger breadth of applications and expand funding. Develop new campus-wide and CCTSI approaches to ensure that pregnant women and their offspring are fairly available to all (including how to reduce conflict with the NIH-supported MFMU network research protocols). Continue efforts to maintain the Perinatal Research Triage and Facilitation Committees. Develop a campus-wide program that replaces the former Baby Blanket Program, to include an on-going research database that is linked to clinical data, ultrasound data, laboratory data, and biobank samples of women (and offspring) who initiate their prenatal care at the UCH and plan to deliver their babies at UCH. Continue recruitment in the Pregnancy Clinic on a basis fair to all investigators, using the HIPPA Consent Form that allows contact of patients who sign the form to be approached for consent to participate in individual projects. Continue liaison with the previous Baby Blanket Director, Dr. Anne Lynch, who maintains a committee to review applications (all sources) for use of stored perinatal data and biosamples. Approximately 25,000 records are in the database, as well as ~20,000 longitudinal plasma samples and ~4,000 longitudinal DNA samples, all paired with data. Charges for use of this data base and paired samples will be applied to investigators approved for this service. The CMH POC will advertise this service through the CMH- CCTSI website. Page -32-

33 Network of Translational Technologies (NeTT) B1: What are the Major Goals: The NeTT program s primary goal is to fund the technologies that are transforming biomedical research. Specifically, the NeTT program exists to: Specific Aim 5: Strengthen our integrated Network of Translational Technologies (NeTT) and laboratories that provide state-of-the-science services for comprehensive clinical and translational research. We will implement a Core Laboratories Tracking & Management System to centralize tracking of the broad range of translational technology resources available to CCTSI members. A major focus is to accurately track utilization to improve cost-efficiencies and prioritization of resource allocation. B1a: Have the Major Goals changed?: No B2: What was accomplished? The NeTT is designed for optimum utility of translational research in four aligned programs. The programs consist of selected cores with similar missions, and utilize lecture forums within each program to educate CCTSI members about technology updates, applications and the potential for cross-disciplinary research. Biomarker Development Program: This program includes the following resources: - Biobank Consortium: A critical interface between basic researchers and translational researchers can occur with the application of defined investigative techniques utilizing human samples. Biorepositories are essential for the discovery and validation of biomarkers as medicine moves toward personalizing diagnosis and treatment for individuals. We established a Biobank consortium through the CCTSI, which processed and stores samples using the most up-to-date NIH guidelines. Acquisition of tissues and products by investigators would be facilitated by the establishment of an honest broker service. - Genomics: Technologies for high throughput sequencing, gene expression platforms, mutation detection, and platforms enabling whole genome assays for genetic variation are highly developed and mature within the NeTT. They have been used to aid in the development of biomarkers, define new causes of genetic diseases, and potentially develop new therapeutic targets. - Proteomics: The Proteomics Core offers investigators access to analytical capabilities and the expertise to perform high-quality proteomic studies. It assists with the identification of therapeutic targets, the elaboration of underlying mechanisms, and the identification of markers of cancer and anti-cancer therapies. Methods for protein and peptide isolation, separations, quantification, identification and bioinformatics analysis, together with expert guidance in study design, are integrated into the service offered by the Core. - Metabolomics: This core supports technologies that enable investigators to perform high throughput analysis of metabolites to inform physiology and pathophysiologic processes. In cancer science, magnetic resonance (MR) is a proven technique for early diagnosis, for pre-clinical and clinical trials with new drugs, and to select or stratify patients. In this context MR measurements are biomarkers. Colorado Translational Research Imaging Center: C-TRIC is a new comprehensive research imaging center that was established in 2010 with the support of institutional funds. The goal of C-TRIC is to create a research imaging environment that will facilitate collaborations of researchers from a broad array of disciplines with imaging scientists, and to provide the organizational structure and state-of-the art imaging facility that maximizes creative translational discovery. - Human Imaging: The expansion of human imaging capabilities has been remarkable. With institutional and CCTSI support, a new PET/CT scanner dedicated to research use was installed in 2012 in the same facility that houses a research MRI instrument. The institution has committed more than $2.5M in infrastructure support for C-TRIC. - Animal Imaging: We have recently instituted a comprehensive Small Animal Imaging Program (SAIP), under the direction of Dr. Natalie Serkova. The goal of the SAIP is to develop a variety of imagingbased techniques in animal rodent models that provide reliable anatomic, physiologic, metabolic and molecular end. The animal imaging techniques (MRI, CT, PET, and bioluminescence) are highly Page -33-

34 complementary and provide both anatomic and mechanistic end points and can be translated into human medicine. - Advanced Microscopy: The Advanced Light Microscopy Core, under the direction of Mark Dell Acqua, PhD, has a number of imaging instruments that deliver a range of important capabilities to users. On a functional level these include: Confocal Imaging, Label Free Imaging, Real Time Imaging, 3D Imaging, Spectral Imaging, Membrane Imaging, Diffusion and Binding Studies, Co-localization Analysis, Molecular Interaction Studies, Fluorescence Lifetime Imaging, and Molecular Photo-manipulation - Radiochemistry: Under the direction of Peter Smith-Jones, MSc, PhD, radiochemistry has been instituted with a comprehensive array of services and research to include: cgmp and GLP compliant synthesis facilities licensed for radioactive laboratory work; Cell harvester receptor binding studies; and Radio HPLC metabolite analysis. The Director search is underway. Translational Therapeutics and Modeling Program: Molecular technologies for vector design, cloning, gene silencing and mutation have evolved to a highly refined state. Moreover, murine modeling has progressed to a point of conditional, organ specific, inducible or repressible systems. Through these advancements, pre-clinical testing of potential drug targets is possible. Moreover, complex animal modeling of human disease or potential therapeutic interventions can be performed. - Functional Genomics: Functional Genomics is a field with enormous potential to advance biomedical research by investigating gene function on a genome-wide scale. RNAi, deep-sequencing and related technologies can be used to find out how entire families of genes function, leading to new ideas for treatment. Based out of the University of Colorado Boulder, this shared resource aims to promote scientific research in the area of Functional Genomics. Ultimately, the goal of our program is to catalyze discoveries that will positively impact the quality of human life. Translational Pharmacology Program: The drug discovery pipeline is well established within pharmaceutical companies. The ability to perform comprehensive drug discovery on a smaller and more focused scale is less prevalent among academic medical institutions. The Translational Pharmacology Program is under the directions of Dr. David Ross, Professor and Chairman of the Department of Pharmaceutical Sciences. Traditional biochemistry approaches are combined with genomic and proteomic analysis for target identification. By the development of computational algorithms, virtual High Throughput screening can be performed based on structural relationships for identified targets. Furthermore, the ability to access libraries of molecular scaffolds enables investigators to identify scaffolds most appropriate for modification as molecular targets. - Computational Modeling and Chemistry: The Computational Chemistry and Biology (CCB) Core Facility, under the direction of Donald Backos, MPH., PhD, provides a wide array of advanced tools and services for computational-based simulations and modeling of chemical and biological systems. - High-Throughput Screening (HTS) and High-Content Screening (HCS): Under the direction of Brian G. Reid, PhD, the HTS/HCS Core specializes in chemical biology as it relates to drug discovery, biological probe discovery, and phenotypic characterization of small-molecule effects on cellular systems. In addition to housing the instrumentation and robotics required for traditional HTS, the Core houses a cutting-edge High Content image-based system for next-generation small-molecule discovery research and analysis in fixed or live cells and cellular systems. - Medicinal Chemistry: The Medicinal Chemistry Core is under the direction of Dr. Michael Wempe and serves to validate proof-of-principle target discovery and assist in preclinical evaluation of compounds by: 1) chemical synthesis; 2) assistance in lead compound identification and optimization; 3) structureactivity relationship (SAR) analysis; 4) improvement of chemical properties associated with ADME and/or toxicity issues; and 5) literature searching 1) Specific Objectives Progress: We have begun the progress of integrating the new Cores at CSU (including the PK/PD core and also the T0.5 Natural Animal Models Core). These cores have been advertised on the web site and explained in presentations. In addition, we have purchased and have begun implementing ilabs Solutions as a Core Lab Management System. Opportunities and Challenges: Defining the overall structure of the Natural Animal Modeling Core and its implementation and focus is ongoing at Colorado State University. Page -34-

35 2) Significant results, including major findings, developments, or conclusions The major results focus on the tighter integration of the cores into thematic groups, the implementation and roll out of the ilabs system and the institution of cross-disciplinary meetings between the Core directors. 3) Key outcomes or other achievements 1. Regular meetings of the NeTT Core leaders with Dr. Kohrt and Dr. Geraci. 2. Institution of 2 new cores at CSU 3. Beginning the acquisition of the Core Management system. B4: What opportunities for training and professional development has the project provided? All of the Cores have a functionality to provide education and technology development to the members of the CCTSI through the utilization of specific seminar series in their related disciplines. B5: How have results been disseminated to communities of interest? All CCTSI users of the Technology Cores disseminate their results widely through the use of publications. In addition, the annual CCTSI Research forum allows individuals to present their results locally and regionally through oral and poster presentations. B6: What is planned for the next reporting period to accomplish goals? 1. Integration and full implementation of the two new cores at CSU: The PK / PD Core and the T0.5 Natural Animal Modeling Core. 2. Implementation of the Core Lab Management System (ilabs) to approximately 9-12 of the Cores. 3. Re-configuring the oversight of the NeTT to include the leadership of Dr. Kohrt and the institution of regular meetings for the group (already accomplished). 4. Completion of a needs assessment for NeTT cores and usage by the CCTSI membership. Over the next 3 years we anticipate that we may need to adjust funding levels to the NeTT Core Labs with our annual NIH budget reductions. Page -35-

36 Novel Clinical Translational Methods Development Program B1: What are the Major Goals: The NCTM intends to transform methodological needs from the CCTSI community into functioning methodology through a selective, two-stage grant process. The NCTM has organized a process to identify research questions requiring novel methodology, develop RFAs for the development of method(s) most likely to have translational impact, and fund the most promising proposals. B1a: Have the Major Goals changed? No B2: What was accomplished? 1) Major Activities Our major activities are to (a) solicit novel methods development requests from researchers within the CCTSI, (b) review requests for scientific quality and novelty, (c) solicit proposals to meet the methods development needs, and (d) review methods development proposals, and (d) encourage new collaborations. 2) Specific Objectives Support new collaborations designed to meet novel methods development needs of CCTSI investigators. 3) Significant results, including major findings, developments, or conclusions (both positive and negative) The process developed 4 new interdisciplinary collaborations between investigators in: OB/GYN and Mechanical Engineering, Anesthesiology and Pharmacology; Medicine and Bioengineering; and Medicine and Neurology. Two of the four collaborations are also inter-institutional with faculty from both the University of Colorado Boulder and the Anschutz Medical Campus participating. After 8 months of each collaboration, all four collaborations are working well together with method development progressing. These are similar results from previous years. Previously reported longer-term follow-up of this approach suggests this as an effective method for developing new collaborations as a means of meeting novel development needs. The primary limitation with this small grant approach is that, with its focus on new collaborations, it differs from most other small grant programs creating some confusion in the CCTSI community and limiting applications. 4) Key outcomes or other achievements Accomplishments include assembling and seating the NCTM standing committee and completing the request for, the evaluation of and the funding of NCTM method development grants. For the recent year, we received 14 letters of intent which led to 13 Phase I applications. The committee chose 6 of the Phase I applications to release as Phase II RFAs. 6 Phase II applications were received. 4 Phase II proposals were funded. B4: What opportunities for training and professional development has the project provided? Nothing to Report B5: How have results been disseminated to communities of interest? Nothing to Report B6: What is planned for the next reporting period to accomplish goals? More frequent dissemination of information concerning the Novel Clinical and Translational Methods Development small grant program is being used in an attempt to further increase the number of applications. Page -36-

37 Research Ethics B1: What are the Major Goals: (list component Specific Aims) The CCTIS Research Ethics is structured to: 1) inform the manner in which research is conducted; capture and disseminate best practices for the responsible conduct of research; 2) involve multiple programs and cores within the CCTSI; and 3) provide ready access for investigators and trainees to a wide range of bioethics services and expertise. The following Specific Aims direct the work of the Core: Aim 1: Integrate ethics learning into regulatory training activities and the CCTSI Clinical Science Program. Aim 2: Create an ethics consultation service to provide expertise and input into research design and conduct. Aim 3: Conduct research to identify best practices to enhance public trust in the research enterprise. We are accomplishing these specific aims through close collaboration with the leadership of Resources and Services, RSAs, and the Community Engagement Core as well as the expansion of ongoing research projects related to research ethics. B1a: Have the Major Goals changed? No B2: What was accomplished? 1) 5 th Annual Research Ethics Conference: a. Title: Protecting Research Participants Privacy: Is It Possible? Should We Care? b. Date: October 9, 2014; Time: 10-2; c. Attendees: 60; d. Evaluations Summary: 11 Questions, mean= ) Research Ethics Consultations: a. 6 Consults b. 1 publication: Chin et al Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience. Surgery 157: ) Hospital Wide Ethics Grand Rounds: a. May, 2014: Ethics on the Borderland: Research or QI? 4) Responsible Conduct of Research Class a. 8 monthly sessions b. 1 comprehensive daylong session 5) Members of PACT Community Consult and Ethics Committee a. Participated in Community Based Participatory Research (CBPR) Consults B4: What opportunities for training and professional development has the project provided? Research Ethics partnered with the Dean of the Graduate School to create a model orientation course for incoming students, which is now in its fifth year. Research Ethics planned and presented the 5th Annual Research Ethics Conference on October, Approximately 60 persons attended. Members of Research Ethics planned and presented Hospital Wide Ethics Grand Rounds in May 9, Approximately 40 persons attended. Members of Research Ethics direct and participate in the Responsible Conduct of Research Course that was ongoing once a month throughout the school year of It culminated with a daylong Page -37-

38 class in June 2014 that offered all eight sessions in one day for those who needed to make up a session or complete all sessions in one day. B5: How have results been disseminated to communities of interest? 1) Publication: Chin et al Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience. Surgery 157: ) 5 th Annual Research Ethics Conference, October 2015 (attendee breakdown n=60) B6: What is planned for the next reporting period to accomplish goals? 1) 6 th Annual Research Ethics Conference, October ) Expanded Research Ethics Consultation 3) Hospital Wide Ethics Grand Rounds, March ) Responsible Conduct of Research Class 5) Joint Grant Proposal to Center for Biomedical Informatics and Personalized Medicine (BIPM), January 2015 a. Title: Bootcamp for Personalized Medicine Biobank b. Joint application: Research Ethics and Community Engagement Page -38-

39 Translational Informatics B1: What are the Major Goals: Translational Informatics has Specific Aims within two CCTSI Grant Sections: Resources & Services (R&S) and Integrated Home for Translational Research (IHTR) From R&S: Specific Aim 4: Provide a network of services to support investigators in designing, conducting and disseminating the highest quality research. One component of Aim 4 is research data management and integration services. From IHTR: Specific Aim 3: Implement systems to coordinate the access, delivery, and sharing of data resources in a secure and compliant environment for translational researchers and communities. Collectively, the Translational Informatics Aims focus on data integration, data management (including data security), and improved access to clinical and research data for sharing across institutions. These objectives remain unchanged and have been the area of most informatics activities. However, as highlighted in Section B2, substantial Informatics resources are devoted to improving investigator access to CCTSI services, improving the underlying CCTSI IT infrastructure, and to improving internal CCTSI administrative workflows and processes as part of the objective to reduce barriers and lower costs for performing translational research. B2: What was accomplished? 1) Major Activities During the past grant year, activities for Data Management and Integration Services included: Expanding existing relationships with the CCTSI Regulatory Core (Enhanced Research Environment Pillar Program) and COMIRB to remove technical and regulatory barriers to creating compliant and secure research. (e.g., for REDCap and Health Data Compass [ institutional wide Enterprise Data Warehouse under development]) Engaging with regulatory and legal representatives to establish the appropriate framework for data sharing policies, procedures, and technologies that encourage data sharing among local, regional, and national research collaborators. (Health Data Compass) Enhancing research data security and regulatory compliance to ensure compliance with HIPAA regulations while promoting data sharing. (REDCap, Health Data Compass) Promoting use of bioinformatics analytic consultative services in experimental design and data analysis for Next Generation Sequencing and Microarray technologies. (Bioinformatics Consultative Services) Expanding research informatics and bioinformatics support services to Colorado State University (new CCTSI partner/affiliate institution). Activities related to Informatics Coordination and Research Data Security included: Implementing a redesigned CCTSI public-facing web site to improve visibility and access to CCTSI services and personnel. Implementing Human Subject Research Protocol Submission web portal that manages document workflows for protocol review across UCH, CHCO, CTRC, and UC Denver. Implementing a web-based employee help desk ticketing system to improve Translational Informatics service requests Implementing new Research Studio Consultation public website for requesting services and managing expert consultants scheduling and workflow. Implementing academic plan review for CCTSI-sponsored Clinical Sciences Graduate Program Initiating a campus-wide enterprise clinical and research data warehouse (Health Data Compass) that will include a comprehensive honest broker data access service linked to IRB approval, de-identification procedures, and secure data management/distribution. Migrating current CCTSI VM server farm into a more secure data center and upgraded hardware. Developing new technologies that promote the use of standard terminologies, leveraging the extensive use of REDCap for data collection. 2) Significant results: Successfully navigated numerous administrative and technical hurdles to finalize and implement a data sharing policy for the use of CCTSI REDCap data management services for Veterans Administration Page -39-

40 patients who are seen by both VA and UCD clinicians. This enormous accomplishment credits the dogged determination of the CCTSI VA liaison, Dr. Pete Watson. Expansion of REDCap personnel in response to continued growth of use of this CCTSI-funded resource across campus and affiliates. Funding approval, initial staffing, Phase 1 RPF development, release, evaluation and award to kick-off systems procurement and software deployment of Health Data Compass, a multi-institutional campuswide integrated clinical, translational and research data warehouse to support clinical innovation and discovery, one of the core CCTSI Translational Informatics objective. The delivery of the first installment of institutional data (UCHealth System, Children s Hospital Colorado, University Physician Inc) containing clear-text PHI occurred 12/23/2014. New policies from CU Office of Information Technology Office of IT Security policies that allow CCTSI REDCap developers to use and create new RC plug-ins. The lack of these policies and approvals has stymied implementing innovative extensions to REDCap deployed at other CTSA locations. The initial CU CCTSI-development plug-in auto-creates the Colorado IRB-required annual recruitment report using standardized demographic forms. A second RC plug-in supports a unique investigator s need to export RC data to SAS, perform a complex calculation, and then return the results that provides graphical comparisons of adult GI residents growing technical expertise with endoscopy-based procedures over time. This tool may be adopted nationally. Plans to populate REDCap data fields directly from the EPIC EHRs have been placed on hold until a stronger use case has been established. Initial discussions with Clinical Coordinators did not elicit strong support for auto-population, and the OHSU DTS program for REDCap is no longer supported. 3) Plans to develop standardized forms tied to national terminologies such as LOINC or RXNorm have been modified. The original vision was to develop large forms with long lists for each data domain that contained pre-configured standardized terms and code sets and to ask REDCap form designers to remove those items that were not relevant to their study. Our new strategy is to encourage the use of standardized terminologies via new features or capabilities enabled by these terminologies. The autogeneration of the annual Colorado Multiple Institution IRB recruitment form is such an example. Key outcomes or other achievements REDCap metrics ( ): active projects; active users; training; Data Management Basics Workshop (4 sessions); Survey Workshop (2 sessions) Bioinformatics metrics:120 consultations resulting in 19 grant applications Web site/profiles monthly hit rates in 2014: 5170 (avg) / 6800 (avg) Bioinformatics Journal Club: participants per monthly seminar Participation in NCATS Accrual in Clinical Trials (ACT) Phase 1 as the only pediatric data partner within this project. B4: What opportunities for training and professional development has the project provided? Translational Informatics Pillar Program provides training via biweekly REDCap tutorials, ad-hoc one-onone consultations, and online recorded video tutorials ( B5: How have results been disseminated to communities of interest? Translational Informatics hosts data management workshops (see B3.4), local REDCap user group sessions, UCHealth Research Advisory Council and contributes to multiple activities with the larger Clinical Research Informatics (CRI) community via participation in REDCap online and annual meeting activities, AMIA CRI presentations and posters. B6: What is planned for the next reporting period to accomplish goals? TI has no plans to significantly alter its current operational foci or plans to achieve the goals. As Health Data Compass (the campus-wide clinical and research data warehouse) becomes operational, multiple CCTSI cores will collaborate to develop research data access policies and to support an Honest Broker service to facilitate data availability. We will emphasize developing data sets that conform to national data sharing platforms, such as i2b2, OMOP, VDW, and PCORnet, to promote broad data sharing within CCTSI and across CTSA institutions. Page -40-

41 Translational Pilot Grant Program B1: What are the Major Goals: The Program provides the infrastructure to organize funding opportunities, prioritize funding opportunities for collaborative efforts in translational medicine, and broaden the reach of the funding opportunities to facilitate integration across Discovery (T1-T2) and Community-Population (T3-T4) Translational Research. To achieve this goal, the Pilot Program seeks to identify areas for potential collaboration, and supply both targeted and open funding opportunities to address specific CCTSI priorities and to open routes for new ideas. AIM 5. EXPAND OUR COMPREHENSIVE PILOT GRANT PROGRAM TO CATALYZE AND PROMOTE NEW, HIGH QUALITY, COLLABORATIVE T1 - T4 INVESTIGATION THROUGHOUT THE CCTSI. A: ORGANIZATION AND CENTRALIZATION OF PILOT GRANT FUNDING OPPORTUNITIES B: EVALUATE GRANT OUTCOMES AND FUNDING OPPORTUNITY PRIORITIES B1a: Have the Major Goals changed?: No B2: What was accomplished? Organizational Characteristics of the CO-Pilot Grant Program: The Colorado (CO)-Pilot Program encompasses funding for trainees through senior investigators, prioritizing interdisciplinary team collaboration on innovative or high risk T1 through T2 research questions, in a disease-agnostic manner. The CO-Pilot Program represents the broadest category of Pilot funding, as well as the highest number of grants funded. This program includes four levels of funding: Mentored Pilot Awards ($30,000) are for beginning investigators (including post-docs and assistant professors in tenure or research tracks) who will partner with two senior mentor investigators. The award is made to the Mentee as the PI of a Mentored Pilot application. Junior Faculty Pilot Awards ($30,000) are for junior faculty who have not attained associate professor rank or above. Independent Investigator / Career Transition Awards ($60,000) are for independent investigators (usually associate or senior assistant professors with independent funding) looking to incorporate a new clinical translational direction into their research. The Team Science Award ($100,000) is for groups of researchers proposing an efficient plan for crossdisciplinary collaboration. A total of $400,000 of annual funding (supported by the CU SOM) is devoted to this program. Newly added to the CO-Pilot program in 2013 are the CSU Pilot Grants. These will have the same criteria, application and review procedure as the CO-Pilot program, up to $30,000 per award (total of $130,000 per year) and be conducted primarily on the CSU campus. In addition, a new CSU-CU Collaboration Pilot Grant will require a co-investigator/collaborator from each university, and will fund up to $60,000 per grant. These grants will encourage CSU-CU collaboration and use of Natural Animal Models of Human Disease as well as other unique CSU resources. Process: Solicitation of applications. Solicitation of applications to all Translational Pilot Award categories will be synchronized to occur at the same time on an annual basis. This synchronization serves to standardize a timeframe for applications, review and awards for all of the award types. The solicitation for new applications will occur each June (Table) and be widely advertised on the CCTSI web site, as well Timeline for Annual Translational Pilot Grant Mechanism Anticipated Annual Timeframe RFA Posting date for all Translational Pilot Programs and Focus Areas June, current year Letter of Intent (mandatory) Due Date August, current year Application Submission Date September, current year Face-to-face Review Panel December, current year Earliest Anticipated Start Date January 1, subsequent year as through numerous announcements to all faculty and trainees at CUD, CU-B, CSU and all partner hospitals, as well as the community organizations associated with PACT. A Letter of Intent by August is mandatory and serves two purposes: choose the appropriate expertise for the review panels, and enable leadership of the Pilot Program to contact individuals for clarification prior to submission of a full application. The prolonged lag time (four months) between release of the RFA and the due date in September is intentional and designed to enable applicants to engage in a thoughtful and collaborative effort toward the application. Page -41-

42 Review of Applications and decision process. The CO-Pilot, Child and Maternal Health Research Pilot, and NCTM focus areas have identical criteria for review and evaluation. Each application is scored by the appropriate Review Panel and ranked according to overall impact score. The scores and ranking are then transmitted to the Executive Committee for consideration for funding. Factors that will be considered in the scoring of the applications are: Innovation Scientific merit of approach Cross-disciplinary or collaborative focus Significance to the CCTSI - Will the results further our understanding / diagnosis / prevention/ or treatment of human diseases? Making use of CCTSI resources is encouraged and will be taken into account in review, but is not mandatory. Investigator integration - Have the investigators made use of new collaborations? Are attempts made to integrate basic and translational researchers in discovery translation? Are efforts made to collaborate with community researchers or community members, if relevant? Environment Major Accomplishments For the current cycle in , 193 applications were received and reviewed, with 24 awards made during this period. Due to the exceptionally high quality of the CU-CSU collaborative pilot project applications (with two very clear standouts and only enough funds to support one project), both Dr. Krugman (Dean, University of Colorado Denver School of Medicine) and Leadership of Colorado State University have each committed an additional $30,000 in order to a support the second $60,000 collaborative pilot project for this year. B4: What opportunities for training and professional development has the project provided? This project is tightly integrated with the objectives of career development in that Mentored and Junior Faculty Pilot awards are designed to assist initial investigators and Independent and Team awards are directed at the professional development of more experienced researchers. B5: How have results been disseminated to communities of interest? The awardees regularly publish the results of their findings. B6: What is planned for the next reporting period to accomplish goals? 1) Continue the excellence of the Pilot Programs 2) Coordinate the RFA dissemination and Review 3) Align the electronic submission and review criteria and scoring systems Page -42-

43 Education, Training and Career Development (ETCD) B. 1. What are the Major Goals?: Specific Aim 1: To enrich the PhD and Masters Clinical Science program and augment the content and outreach of our clinical research education and responsible conduct of research programs. Specific Aim 2: To improve the impact and effectiveness of our KL2 and career development programs. Specific Aim 3: To enhance our pre-doctoral TL1 training and pipeline programs and ultimately build a diverse clinical and translational workforce throughout the Rocky Mountain region. B. 1a: Have Major Goals changed? No. B.2. What was accomplished?: Clinical Science Program (CLSC)- Currently, the CLSC has 103 students (65 Masters of Science in Clinical Sciences (MSCS) students and 38 PhD students), and remains the largest non-professional degree granting program in the UCD Anschutz Medical Campus Graduate School. The collaborative program, between the CLSC and the Colorado School of Public Health, for the MS in Health Services Research degree started this Fall 2015 with four students. Two of the four newly proposed courses were reviewed and approved by the Graduate School and were offered starting the Fall 2014 term, CLSC 7653 Dissemination and Implementation Research in Health (2 credit hours) and CLSC 6590 Navigating the Clinical Research Regulatory Maze (1 credit hour). The course objectives for CLSC 6590 Navigating the Clinical Research Regulatory Maze include: 1. Describing regulatory considerations in clinical research 2. Distinguishing and explain a quality improvement project versus a research project 3. Detailing the preparation, process, and follow-up of an FDA audit 4. Preparing effectively for an FDA audit 5. Determining which items and services are potentially billable to third-party payers 6. Explaining the approval processes for medical devices 7. Describing the various regulatory and contractual considerations when conducting research collaboratively within and outside one s institution. The course objectives for CLSC 7653 Dissemination and Implementation Research in Health include: 1. Describing the importance and language of Dissemination and Implementation science and practice. 2. Detailing the theories and frameworks that are commonly used in Dissemination and Implementation research and practice. 3. Describing various study designs and measure that support Dissemination and Implementation science and practice. 4. Detailing Dissemination and Implementation methods and challenges across various settings and populations. 5. Designing for Dissemination and Implementation 6. Developing a Dissemination and Implementation plan. In addition, two new surgery fellowship training programs have incorporated our coursework into their programs and bring eight students to the MSCS degree program. KL2 Mentored Career Development - The Career Development award provides up to three years of funding to investigators involved in clinical translational research. The 3 vacancies in our KL2 program were filled in October 2014 by Mehdi Fini, PhD, Mark Jeong, MD, and Brian Berman, MD. Each of the 8 scholars in this year s program plan to attend the National KL2 Meeting in Washington, DC this April and present on their research. The new Pre-K Grant review program directed by Dr. Cara Wilson has completed its 1 st round of reviews. This program provides an internal review of first time career development awards to improve funding and build on the success of the K to R. Six participants attended the inaugural session, along with a variety of mentors and ad hoc reviewers. A second round is currently underway with letters of intent due in early February. A new reviewer, Paul MacLean, PhD was added to this program in December Clinical Faculty Scholars Program (CFSP) This tuition supported program prepares junior faculty for careers in community translational research and helps them apply for (and receive) their first career development or independent investigator awards. Ongoing mentorship is provided, along with a guarantee of 50% protected time for research. The application process is currently underway to select the 2015 cohort. K To R grant review Page -43-

44 program (KTR) Program goals include: improving success rates in the transition from mentored career development (K) to independent investigator (R) funding, increased mentoring of junior faculty in regard to successful research proposals, and insight into the process of the grant review panel. This year a new core reviewer was added, Mary Weiser-Evans, PhD. Leadership in Innovative Team Science (LITeS) This program is designed to provide leadership and career development skills to participants, as well as to build cross-school social networks. A new cohort of 28 senior faculty and administrators (including representatives from University Hospital, Children s Hospital Colorado, Colorado State University) began in September A full series of 8, day-long workshops is planned for the coming year with sessions on Managing Difficult Communications, Peer Coaching, Emotional Intelligence, and Working in Teams. A team project focused on tackling a particular problem in UCD policy or process is the culmination of the program. And, the final meeting provides an opportunity for participants to share their policy improvement recommendations to University leadership. Colorado Mentor Training Program (CO-Mentor) A fifth cohort of mentor/mentee pairs has commenced 4, day-long workshops with the initial session occurring in October Topics include: Money Mentoring, Goal Setting, and Meeting Management. This program includes many senior level graduates of the LITeS who have come with their mentees and will ultimately serve as a pipeline back into LITeS. TL1 Predoctoral Program- A new Clinical Experience Director, Marion Sills, MD, was selected in August She will attend monthly workshops and revamp the clinical experience reporting process. In addition, the seventh round of CCTSI TL1 fellowships was reviewed in May Eight trainees were awarded 1 year of stipend support, tuition, research & travel funds in July All of these trainees will attend and present posters at the National Pre-doctoral Clinical Research program meeting which is now combined with the KL2 meeting in Washington, DC in April Summer Undergraduate Minority Mentoring in Translational Science (SUMMiT) SUMMiT was started in 2010 and brings together underrepresented students from a variety of existing programs to enhance research experiences in translational science. The CCTSI expanded the size of many existing research programs at UCD by funding additional slots for underrepresented minority students; and matched students with research labs to provide relevant work study experience to individuals pursuing undergraduate science degrees. Denver Student Training in Research Science (STaRS) This pipeline program was begun in the spring of 2011 and includes underrepresented high school students from several metro Denver schools. A series of lectures, training and mentoring opportunities designed to give students positive exposure to the Anschutz Medical Campus is ongoing. B.4. What opportunities for training and professional development has the project provided?: A new series providing professional training opportunities to CCTSI staff is underway. This program, developed by Emily Warren, ETCD Programs Manager, will provide resources and training opportunities to CCTSI personnel and affiliates with the goal of building and sustaining a more cohesive team environment. This series of events will take place approximately quarterly and begins mid- February. Topics include: Building a Respectful Workplace, Generations at Work, Stress Management, and Communication Skills. B. 5. How have results been disseminated to communities of interest?: A series of ETCD-related articles are in progress to be submitted for publication in the journal, Clinical and Translational Science in These articles examine current challenges in the educational pipeline spanning the continuum from high school students pondering a career in biomedical research to senior investigators in academic leadership positions. Collaborators at CTSAs from University of Pittsburgh and Columbia University are already on onboard with the project and the first article will be ready for submission early January B.6. What is planned for the next reporting period to accomplish goals? We will continue to closely monitor all of the active ETCD programs for their outcomes and feedback received, and make modifications suggested by the Tracking, Assessment and Evaluation Core. We will seek alternative funding sources for the LITeS program, the funding for which is planned to end after year 3 from the CTSA NIH grant, because of the annual reductions in our NIH CTSA budget. We will work with the Biostatistics (BERD) Core to improve integrating biostatical training with the Education programs. Page -44-

45 KL2 Mentored Career Development Program B. 1. What are the Major Goals?: Specific Aim : To improve the impact and effectiveness of our KL2 and career development programs. B. 1a: Have Major Goals changed? No. B.2. What was Accomplished: The 3 vacancies in our KL2 program were competitively filled in October 2014 by Mehdi Fini, PhD, Mark Jeong, MD, and Brian Berman, MD. B.4. What opportunities for training and professional development has the project provided?: A new collaboration has begun between internal K12/Career Development programs at the University of Colorado and the CCTSI sponsored KL2 program. The aim of this partnership is to enhance existing programs with additional opportunities for didactic training and to encourage interaction and collegiality amongst all K scholars on campus. K scholars met with Jennifer Kemp, PhD regarding grant writing in September 2014 and approximately 20 K scholars attended. A second training, Managing Difficult Communications presented by Eva Aagaard, MD, is planned for January, KL2 scholars and their mentors are required to attend the CCTSI sponsored CO-Mentor training program. In addition, many of the mentors have completed the Leadership for Innovative Team Science (LITeS) program including all of our program directors. The K to R grant review program provides advanced comments and pre-review of R and other independent investigator awards 3 times per year. Many K scholars have participated in this program and have successfully transitioned to R awards by the end of their 3 year of K funding. All current scholars are encouraged to take advantage of this CCTSI funded program now in its 5 th year. Four KL2 scholars attended a local course in Denver, CO in August 2014 by Edward Tufte, PhD, regarding data presentation skills. Costs for the course were underwritten by the CCTSI. All scholars and their mentors completed mentor-mentee contracts delineating roles and expectations, along with goals and timelines, for mentees and their mentors. B. 5. How have results been disseminated to communities of interest?: A series of articles are in progress to be submitted for publishing to the journal, Clinical and Translational Science in These articles examine current challenges in the educational pipeline spanning the continuum from high school students pondering a career in biomedical research to senior investigators in academic leadership positions. Collaborators at CTSAs from University of Pittsburgh and Columbia University are already on onboard with the project and the first article will be ready for submission early January B.6. What is planned for the next reporting period to accomplish goals? All of the scholars in this year s program plan to attend the National KL2 Meeting in Washington, DC this April and present on their research. Several KL2 scholars have agreed to mentor Master s level internship students in a Biomedical Sciences Program at a partner institution. Page -45-

46 TL1 Pre-Doctoral Training Program B. 1. What are the Major Goals?: Specific Aim 3: To enhance our pre-doctoral TL1 training and pipeline programs and ultimately build a diverse clinical and translational workforce throughout the Rocky Mountain region. B. 1a: Have Major Goals changed? No. B.2. What was Accomplished?: A new Clinical Experience Director, Marion Sills, MD, was selected in August She will attend monthly workshops and revamp the clinical experience reporting process. A new instructor for the Tissue Biology and Disease course was also selected, Roger Bannister, PhD. In addition, the seventh round of CCTSI TL1 fellowships was reviewed in May Eight trainees, all from different PhD programs, were awarded 1 year of stipend support, tuition, research & travel funds in July B.4. What opportunities for training and professional development has the project provided?: An integral part of the TL1 program is the TClub, a monthly training and professional development series. The series begins with a required New Trainee Orientation and Clinical Experience Training which outlines the program and expectations throughout the year. Other scheduled topics include: Networking & Professionalism, Understanding Technology Transfer, How to Write a Grant Proposal, Introduction to Clinical Trials, How to Present a Poster, Understanding Diversity and Healthcare Delivery, and How to Give a ResearchTalk. In addition to these didactic trainings, students in the TL1 program choose a book (relevant to translational research) to read and discuss as a group. This year s selection was Mountains Beyond Mountains by Tracy Kidder the story of Paul Farmer, an AIDS and TB doctor and researcher in Haiti. Feedback from students regarding these trainings has been excellent. Trainees in the TL1 program utilize online trainings such as CITI and are encouraged to attend other offerings on campus such as Responsible Conduct of Research and Clinical Trials trainings. TL1 mentors are encouraged to attend the CCTSI sponsored CO-Mentor training program. In addition, many of the training program directors in the Graduate School have completed the Leadership for Innovative Team Science (LITeS) program including our current and past TL1 directors. B. 5. How have results been disseminated to communities of interest?: A series of articles are in progress to be submitted for publishing to the journal, Clinical and Translational Science in These articles examine current challenges in the educational pipeline spanning the continuum from high school students pondering a career in biomedical research to senior investigators in academic leadership positions. Collaborators at CTSAs from University of Pittsburgh and Columbia University are already on onboard with the project and the first article will be ready for submission early January B.6. What is planned for the next reporting period to accomplish goals? All of the trainees will attend and present posters at the National Pre-doctoral Clinical Research program meeting which is now combined with the KL2 meeting in Washington, DC in April A new round of trainees will be selected in June Page -46-

47 Novel Clinical Translational Methods Develop Pilot Project Investigator: Natalie J. Serkova, PhD, MSc era Commons Username: HSC.SERKOVA.NATALIE Investigator Status: Associate Professor Project Title: Small Animal microct Colonography and FDG-PET for Non-Invasive Imaging of Colitis and Colon Inflammation Project Period: 5/1/2014-4/31/2015) Progress Summary: Description: Inflammation is central to the pathogenesis of a wide range of acute and chronic medical conditions. Various autoimmune diseases including inflammatory bowel disease (IBD, namely the Crohn s disease and ulcerative colitis) have a well presented autoinflammatory component. Various sophisticated mouse models have been developed; unfortunately, there are no established or validated approaches to noninvasively assess the presence or the degree of colon inflammation in animal models in order to predict disease progression and transformation to the malignant phenotype. Because endoscopic examinations are complicated in the assessment of small animal models of IBD as well as CRC, other clinical surrogate markers such weight loss have to be used to avoid necroscopy on precious transgenic mouse models of IBD. This Phase II proposal by Dr. Serkova aims to develop a multimodal microct colonography/ FDG-PET approach for non-invasive imaging of colon inflammation and its progression to colorectal cancer (CRC) lesions. A fused image analysis of high-resolution micro CT-based colonography with metabolically active lesions by FDG-PET will provide accurate and reproducible changes in inflamed colon of the mouse. A major advantage of this multimodality platform will be that in the future CU investigators (including the Phase 1 PI, Dr. Eoin McNamee) can perform longitudinal studies on the same animal non-invasively such as capturing unique Project Progress: Presently, we are validating the mouse model for the IBD and colon inflammation. We have performed the very first FDG-PET/CT studies which yielded very promising results (Figure below): we saw highly increased uptake of 18F-labeled radioacvtive glucose analogues (18F-fluoro-D-deoxyglucose, FDG) by inflamed colon in the mouse model of IBD. The normalized uptake values (NUV) of FDG in the IBD model was 3.75 when compared to the control NUVs of <0.1. IACUC Protocol: #80314(01)1C Page -47-