Patient-Powered Research Networks (PPRNs) Research Demonstration Projects Town Hall

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1 Patient-Powered Research Networks (PPRNs) Research Demonstration Projects Town Hall Sarah Daugherty, PhD, MPH Senior Program Officer, Science Donna Gentry, MA Contracts Administrator, Pre-Award Jaye Bea Smalley, MA Engagement Officer, Science June 24, 2015 << Develop infrastructure for D&I >>

2 Agenda Programmatic Overview Administrative Requirements Submitting Questions: Submit questions via the chat function in Meeting Bridge. Questions and Answers Ask a question via phone (an operator will standby to take your questions).

3 Programmatic Overview

4 Overview PPRNs are intended to support patient communities motivated to participate in clinical research within PCORnet This PFA seeks to fund PPRN-initiated research based on questions generated and prioritized within the PPRN community PCORI will be funding up to 8 individual PPRN research projects Project Budget: Up to $2.5 million in total costs Project period: Maximum of 3 years

5 Objectives of this PFA There are three main objectives: 1. Relevance: answer important patient-identified research questions generated by the PPRN community 2. Collaboration: partner with other PPRNs to use, develop, and contribute to PCORnet s shared tools and resources (The PCORnet Commons) to accelerate the conduct of research using PCORnet 3. Evaluation: assess the project s contribution to and impact on the development of the PCORnet Commons and on PCORnet s capacity to support an increasing volume of research

6 Relevance of Research Question Patient-driven process to generate and prioritize research questions Importance of research question and demonstration that research addresses an evidence gap Only patient community of the applicant PPRN must generate and prioritize the application s research questions Suitability of research design to answer question Comparative clinical effectiveness research conducted as observational studies or randomized clinical trials are preferred. Use of CDM is optional, but encouraged where appropriate Single IRB of record for each study

7 Collaboration Encourage collaboration between two or more PPRNs Expect collaboration around development and/or sharing of tools and resources Research plan must have clear collaboration component How activities will be managed and led, highlighting key partner responsibilities How collaboration will be enhanced and conflict mitigated Relevant training or resources necessary to facilitate effectiveness of collaboration Each PPRN can lead only one LOI and participate in a maximum of three LOIs Strength of PCORnet depends on ability to collaborate across PPRNs, CDRNs and other stakeholders

8 Evaluation Plan A primary aim of the demonstration projects is to assess and develop the PCORnet infrastructure Applications should include a clear evaluation plan to assess the contribution and impact of the project on Strengthening PCORnet s capacity to conduct research Enhancing the PCORnet Commons through collaborative efforts that result in meeting technical assistance needs and developing scalable resources Results from evaluation will be described in an interim report to PCORI (end of first year) and summarized in a final report at the end of the project.

9 Criterion for Review Criterion 1. Potential for study to improve health care and outcomes important to the PPRN participant community Criterion 2. Technical merit sufficient in research design to ensure study goals will be met Criterion 3. Patient-centeredness at every stage of the research Criterion 4. Patient and stakeholder engagement, with relevant stakeholders from population of interest

10 Letter of Intent and Merit Review Letter of Intent Only Phase 2 awardees will be eligible for the award Reviewed by PCORI staff for programmatic fit and responsiveness to the PFA and Application Guidelines LOI due July 31, 2015 by 5pm (ET) PCORI s merit review is a multiphase process: Preliminary review of full applications In-person panel discussions PCORI program staff review the scores and comments for the meritorious applications and consider the fit of applications within the programmatic vision PCORI Selection Committee recommends applicants for funding Board of Governor s award approval (expected no later than January 2016)

11 Administrative Requirements

12 Eligibility to submit a Letter of Intent For this limited PFA, PCORI is soliciting applications only from PCORnet PPRNs successfully funded in Phase II. This includes Phase I PPRNs that receive Phase II Awards and new Phase II Awardees.

13 SUBMITTING AN LOI An LOI is required and must be submitted prior to the deadline. Download the PFA-specific Letter of Intent Template, found on the Funding Opportunities page on PCORI website. To submit an LOI, you must go into PCORI Online, Use Chrome or Safari browsers to access the system. Complete the required fields and upload the completed PFA-specific LOI into the system. You must upload your LOI as a PDF file. Follow naming conventions. Begin the LOI as soon as possible Log into the PCORI system early to address additional LOI questions. DUE DATE FOR LOI: JULY 31, 2015 BY 5:00 P.M. (ET) PAGE LIMIT: FOUR PAGES

14 SUBMITTING AN LOI Begin the LOI as soon as possible. Log into the PCORI system early to address additional LOI questions. For detailed instructions, please see the PCORI Online System User Manual: Start a Letter of Intent on the PCORI website. An applicant can save information by clicking the Save button in the top right corner. DUE DATE FOR LOI: JULY 31, 2015 BY 5:00 P.M. ET PAGE LIMIT: FOUR PAGES

15 Competitive LOI Process LOIs are screened on the following administrative criteria: Page Limits: LOIs cannot be more than 4 pages. LOIs that exceed four pages will not be reviewed. Proper use of naming convention Proper formatting - for formatting instructions, please reference the instructions listed on the LOI Template and the Application Guidelines LOI Template has specific and detailed instructions on how to complete the document Applicants will be notified no later than August 12, 2015 as to whether they have been selected to submit a full application

16 Budget and Period Limitations Funds & Budget Total costs: $2.5 million over the life of the project Indirect costs: up to 40% Institutional base salary up to $200,000 Indirect costs are capped on subcontracts / sub awards The limit for Scientific Travel is $10,000 over the duration of the project. There is no cap on Programmatic Travel Period of Performance 3 years

17 Resources

18 Engagment Resources PCORI Engagement Rubric: Sample Engagement Plans PCORI Compensation Framework: Framework-for-Engaged-Research-Partners.pdf

19 Additional Application Resources Refer to the funding opportunities page in our Funding Center ( for the following resources: PFA and Application Guidelines PCORI Online User Manuals Applicant Training: General Applicant FAQs: PCORI Online: Research Methodology:

20 Submission and Key Dates What When LOI-Applicant Town Hall June 24, 2015 LOI deadline Applicants notified as to whether they have been selected to submit a full application Applicant Town Hall (if invited) July 31, 2015 by 5:00pm ET August 12, 2015 by 5:00pm ET September 1, 2015 at 3:00pm ET Application Deadline (by invitation only) September 30, :00pm ET Merit Review Dates December 10-11, 2015 Awards Announced January 2016 Earliest Start Date January 2016

21 Questions and Answers Submit questions via the chat function in Meeting Bridge Ask a question via phone (press *7) Contact Us: Schedule a call at Call ( programmatic inquires) us at sciencequestions@pcori.org Call ( administrative and technical inquires) us at pfa@pcori.org

22 Thank You Rachael Fleurence, PhD Program Director, Science Sarah Daugherty, PhD, MPH Senior Program Officer, Science Donna Gentry, MA Contracts Administrator, Pre-Award Jaye Bea Smalley, MA Engagement Officer, PCORnet