CAMPUS ALBERTA. Health Outcomes and Public Health. Brian H. Rowe, MD, MSc Associate Dean (Clinical Research) FoMD, University of Alberta

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1 CAMPUS ALBERTA Health Outcomes and Public Health Brian H. Rowe, MD, MSc Associate Dean (Clinical Research) FoMD, University of Alberta

2 Canada s Strategy for Patient Oriented Research Support for People and Patient- Oriented Research and Trials (SUPPORT) Units.

3 Outline Background and history on SPOR. Alberta approach: Campus Alberta Heath Outcomes and Public Health Committee; Discussions with CIHR; Alberta s draft SPOR SUPPORT Unit Document; Recent updates. Open discussion.

4 What is meant by Health Outcomes? Many terms used to describe what we do. What its not ( discovery science ): Basic science research (e.g., test-tubes, microscopes, rats) What it is: Clinical research (Theme II): Diagnostic tests/health outcomes; CCTs/RCTs; Knowledge synthesis/translation Health Services/Systems (Theme III); Population health (Theme IV). Key issue: many different opportunities.

5 Translational model Westfall, J. M. et al. JAMA 2007;297:

6 Bad news for patients Valley 1 refers to the decreased capacity to translate the results of discoveries generated by basic biomedical research in the laboratory to the bedside as well as to successfully commercialize health discoveries. Valley 2 refers to the limited capacity to synthesize, disseminate and integrate research results more broadly into health care decision-making and clinical practice.

7 SPOR History SPOR document produced in February Committee: multi-disciplinary Canadian research leaders commissioned by CIHR. Lead Author: Paul Hebert, Past Editor in-chief, CMAJ. Dissemination: Spring Leadership: P Hebert (2010) J Rouleau (2011) P Moody-Corbet (2012).

8 SPOR Definition Patient-oriented research is defined by CIHR as a continuum of research, from initial studies in humans to comparative effectiveness and outcomes research, and the integration of this research into the health care system and clinical practice. The goal of patient-oriented research is to better ensure the translation of innovative diagnostic and therapeutic approaches to the point-of-care, as well as to help the provinces and territories meet the challenge of delivering high quality, cost-effective health care. It involves ensuring that the right patient receives the right clinical intervention at the right time, ultimately leading to better health outcomes.

9 SPOR Highlights Goal: Improving health outcomes through research. Aims: To enhance clinical applications and economic impact of health innovations; To provide health professionals and decision-makers with information on how to deliver high-quality care and services in a cost-effective manner. Implies a continuum: From first in patients studies. To how new and old drugs, devices and procedures are integrated into health systems.

10 Four major components of SPOR 1) Improve the research environment and infrastructure; 2) Set up mechanisms to better train and mentor health professionals and non-clinicians; 3) Strengthen organizational, regulatory and financial support for multi-site studies; 4) Support best practices in health care.

11 Component 1 Improve the research environment and infrastructure: Develop SUPPORT Units across Canada Integrate research activities into the health system Conduct research over the continuum of care, from prevention through diagnosis and treatment Create networks for patient-oriented research Focused on specific disease topics Capitalize on clusters of excellence in the clinical and scientific communities Establish programs to build capacity in areas of greatest need, such as primary care and chronic disease management

12 SPOR: local SUPPORT units Research networks are underpinned by local SUPPORT units that provide the resources and personnel to conduct research day to day. SUGGESTED SUPPORT UNIT FUNCTIONS CORE FUNCTIONS SPECIALIZED MODULES Data Management Biostatistics/Methods Support Project Management Consultation and Education Large International Trials Systematic Reviews Biobanks/Translational Medicine Knowledge Translation Integrated within a local clinical/care setting. Provides communities with access to expertise and resources (i.e. core functions and specialized modules). Enhances attraction and retention of talent to communities. Creates linkages with health centres (from tertiary hospitals to primary care centres), and national and international health stakeholders.

13 Research Networks

14 Component 2 Develop human capacity for patient-oriented research: Train more health professionals in health-oriented research; Mentor, develop and support careers of researchers; Train more non-clinicians with advanced degrees in core research methodology; Re-engineer career training and salary awards to build capacity in patient-oriented research for individuals aligned with patient-oriented research units.

15 Component 3 Strengthen organizational, regulatory and financial support for multi-site studies: Streamline ethics review for multi-centre trials; Adopt a national template for contracts and interinstitutional agreements; Ensure that Good Clinical Practice (GCP) standards meant for industry do not stifle investigator-initiated research efforts; Develop national standards of operation for all clinical research activities.

16 Component 4 Support best practices in health care: Develop more capacity for knowledge synthesis; Develop training for guidelines developers; Enhance guidelines with new implementation tool (e.g., standardized order forms and algorithms of care); Develop a KT strategy that outlines how to disseminate research information to the right target audiences.

17 What we do know SPOR National Committee (J Magnan - AB): Representation from across the country and from different stakeholder groups including patient advocacy, health charities and Rx&D. SPOR Working Group Five scientific directors, the Executive Director of the DSEN, the VP Research, Director of the SPOR Office and chaired by the CIHR President. Four External Advisory Committees: Health Research Ethics Review (BHR - AB); Data strategy (?); Clinical studies (?); Training and career development (?).

18 Objectives: Health Research Ethics Review External Advisory Committee To assist the SPOR National Steering Committee with advancing ethics harmonization and improving the efficiency of patient-oriented research in Canada by: Identifying the barriers that currently exist across the country with respect to streamlining research ethics review and subsequently recommending steps to improve the process. Identifying the tools and strategies to improve the ethics review process of patient-oriented research, including by improving education of researchers, Research Ethics Board (REB) members and staff. Exploring the opportunities for information sharing and communication among REBs.

19 Timelines 2012 Federal budget preserved SPOR (and CIHR). Roll-out of SUPPORT Units will be based on readiness of the jurisdiction to meet funding criteria. (e.g. 2 or 3 Units may be launched in the first round). We plan on being one of those units (MN, NS). Moratorium: February 2012.

20 SPOR SUPPORT Unit Requirements Data platforms and services. Methods support and development. Health systems research and knowledge translation. Clinical trials. Career development and methods. Consultation and project management. 1:1 funding, 1 unit (AB 7 provinces and Maritimes)!

21 Other Application Requirements Public engagement (SCNs): Must provide plan to: Engage patients and the public individually or collectively in the development and governance of the Unit; Involve patients and the public in setting local priorities for health services research and decision making. Sustainability : Must provide plan to: Demonstrate commitment to maintain capacity and expertise developed by the Unit beyond the term of the SUPPORT Unit funding. Evaluation: Must provide plan to: Evaluate deliverables. Process for streamlining research ethics review.

22 AB Planning to date CA-HOPH meetings (started May 2010). Province wide (Calgary January 2012). CIHR AB discussions: ongoing since May U of A, U of C, U of L developed a daft proposal for discussion with SPOR in January Multi-disciplinary; Partners: AIHS and AHS. Presentations to: AHN, Faculties, government. To date, no money has been dispersed.

23 Alberta SPOR SUPPORT Unit: Organizational Structure CIHR SPOR SUPPORT Coordinating Group Alberta SPOR SUPPORT Board of Directors Alberta SPOR SUPPORT Steering Committee Alberta Academic Health Network (AHN) Strategic Clinical Networks (SCN) Leads Alberta SPOR SUPPORT Unit Management Team Methods/ Clinical Trials Clinical registries/ Administrative data holdings Health Economics KS / KT Training Administration Black boxes comprise the AB SPOR SUPPORT Collaborative SCN Research Leads and Staff

24 Getting to the finish line: Nationally Await next SPOR National Steering Committee decisions (May 2012). Continue dialogue with CIHR and SPOR; however, clarity is mandatory. Continue development of AB-SPOR SUPPORT Unit proposal: Writing Committee? Continue to participate in SPOR committees/provide feedback.

25 Getting to the finish line: locally. What is needed: Enhance Campus Alberta collaborative links; Commitments from government (AHS, AH&W) and funders (AIHS); Demonstrate skills in a variety of SPOR areas (e.g., Biostats, HE, Methods, KT); Commitments on databases access (DIMR, AH&W - NDAP); Demonstrate strong/innovative training opportunities (e.g., undergraduate health, MSc, PhD); Harmonized ethics; Finalize proposal/discussion.

26 Thank you! Questions?