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Patient-Centered Outcomes Research Institute
Program Development Committee(PDC) Report
PCORI Board of Governors Baltimore MD March 5, 2012
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Update on PCORI Pilot Projects
PPP
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PPP Selection Committee
Chair: Gray Norquist
Advisor: Christine Goertz non-voting
Members:
Kerry Barnett
Carolyn Clancy
Arnie Epstein
Gail Hunt
Steve Lipstein
Sherine Gabriel
Clyde Yancy
Joe Selby
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Pilot Projects Deliberations Process
Working Group
• Determines specific criteria to be considered by the PCORI Selection Committee in determining and recommending an appropriately balanced slate of awards.
PCORI Selection Committee
• Meets to review materials.
• Considers the balance of priority-scored applications across selected criteria, requesting additional analysis and options from staff, as needed.
• Prepares a recommended slate of selected projects for funding consideration.
Board of Governors
• Meets to consider the recommended slate.
• Reviews the slate based on priorities and balance to ensure appropriate distribution.
• Requests additional options, if needed.
• Approves a final slate of selected projects for funding.
PCORI Staff
• Analyzes the applications using priority score and the criteria.
• Provides a list of award options based on Working Group recommendations.
• Supports the PCORI Selection Committee and Board of Governors by providing revised options, as needed.
Initial recommendations made. Under review by Methodology Committee
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Balance Criteria
Priority Score
Among Highest Scoring Applications
Area of Interest
Population
Methods
Geography
Discipline of PI
Seniority of PI
Condition
Stakeholder/Patient Involvement
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12/26 1/9 1/23 2/6 2/20 3/5 3/19 4/2 4/16 4/30 5/14 5/21 5/28
Merit Review (CSR)
Determine Balance
Criteria
Pull & Vet Data & Load
Spread Sheet
Selection Committee
Recommendations
Development of Funding
Recommendations
Board Deliberations &
Final Decisions
Business Review Process
Awards Process
Pilot Projects Timeline
Merit Review Scores Received
Announcements Made
Present to Board/Board Consideration
Present to Board/Board Consideration
Present to Board/Board Consideration
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PCORI Peer Review Evaluation
Post Survey Instrument
- NIH administered PCORI-developed stakeholder and scientist
surveys at the end of the merit review to gain insights into
the review experience
Observational Instrument
- Instrument was completed by PCORI observers in
attendance at 10 randomly selected review meetings
Merit Score Data
- We have data on preliminary and final scores for each
application, including information on the six PCORI Review
Criteria
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Update on PCORI Pilot Projects
Public Comment Results
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Public Comment Process and Timeline
Aggregate/Analyze Input
1
Assess Suitability of Themes
2
Conduct Initial Evaluations
3
Preliminary Voting
4
Voting Conference to Reach Consensus
Recommendations
5
Recommend Changes for Board Decision
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March 15-March 26
March 27
March 28-April 6
April 9
April 11 (PDC F2F)
April 17 (Open meeting being planned)
Staff
PDC*
Staff
PDC*
PDC*
PDC*/Staff
*Any interested Board/MC Member is welcome to participate
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Public Comment Analytics
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Public Comment Analytics
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Update on PCORI Pilot Projects
May, 2012 PFA Process and Timeline
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1 2 3 4 5 6 7 8 9
Month Jan Feb Mar Apr May Jun July Aug Sept
Designate PFA WG Leads
Hire (Contract) PFA Writers
Draft Broad PFAs (May PFAs)
Targeted Priority #5 PFAs (July)
1st Draft of Literature Review; Knowledge Gaps; Example Questions
Incorporate PPP Input
Revised Version Incorporating Comments
Finalized PFA
PDC Calls
PDC F2F
Board of Governors’ Call
Board of Governors’ F2F
Grants Management Process
MC Report
Incorporate Public Comment Input
Timeline for Development of First PFAs
1
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PFA WG Membership Specificity for May Announcements DECISIONS
Red Board of Governors Meetings Green Program Development Committee Milestones Purple Staff Blue Methodology Committee LEGEND
1 2
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PFA prepared by PCORI staff, contracted research organization (CRO) and Board participants
CRO’s sign confidentiality agreement and are barred from submitting application to any of the 5 PFAs until 3rd round – March 2013
Open competition
Applications reviewed by CSR a la PPP’s
Successful applications administered by PCORI
Current Plans – Priorities 1 - 4
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National Priority Board/MC Member 1
Board/MC Member 2
Board/MC Member 3
PCORI Staff Scientist
Identified
Comparative Assessment of Options for Prevention, Diagnosis, and Treatment
Harlan Krumholz
RFP Issued
Improving Healthcare Systems Arnie
Epstein Christine Goertz
Leah Hole-Curry
RFP Issued
Communication and Dissemination Research
Gray Norquist
Dominick
Frosch
Addressing Disparities Carolyn Clancy
Anne Beal
RFP Issued
Accelerating PCOR and Methodological Research
Michael Lauer
Jean Slutsky
Contract
with AHRQ/NIH
PFA Development Teams
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Proposed Plan for Priority #5
• PFA written by PCORI staff, AHRQ staff, NIH staff, MC
• Separate Funding Announcement (i.e., separate from that written for analytic methods)
• Solicitation and Review managed by AHRQ and NIH through contracts from PCORI to AHRQ and NIH
• “Focused Competition” – with clear data and governance requirements, including engagement of relevant stakeholders
• Funding through Cooperative Agreement grant mechanism with shared as well as project-specific goals.
Clinical Research Data Infrastructure
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Rationale for Contracting with AHRQ
• AHRQ and NIH have years of experience in this area that will be invaluable in helping to write the PFA and overseeing the research
• We have a clearer idea of gaps and opportunities– the PFA must be fairly specific (i.e., targeted)
• AHRQ and NIH staff have knowledge of current state of the science
• The proposed funding arrangement is a cooperative agreement, where grantees work together with PCORI, AHRQ, and NIH
• AHRQ and NIH have expertise running cooperative agreements
• The statute explicitly encourages PCORI to contract with AHRQ, NIH and other federal funders of CER; experience of AHRQ and NIH efficiency and value for taxpayers
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Analytic Methods
• Close collaboration with the MC
• AHRQ and NIH have a long track record of working on CER/PCOR methods research – having them involved helps minimize risks of redundancy
• PFA is more likely to be targeted than priorities 1-4 but probably not as targeted as that for research data infrastructure.
• Not as clear this would be a cooperative agreement, though it could be.
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March 5, 2012
Patient-Centered Outcomes Research Institute
PCORI Dissemination Workgroup
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Carolyn Clancy, Co-Chair
Sharon Levine, Co-Chair
Lawrence Becker
Allen Douma
Howard Holland
Gail Hunt
Freda Lewis-Hall
Steve Lipstein
Brian Mittman
Robin Newhouse
Grayson Norquist
Jean Slutsky
Members of the Workgroup
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Dissemination Accelerating Components: Proposed Checklist
Identify stakeholders (stakeholders include patients, caregivers, clinicians, communities, policy makers and institutions) relevant to your proposed study
Describe at which points in your proposed study stakeholders will be engaged
Describe how you will engage stakeholders at each identified point during the study and at its conclusion
Stakeholders
Engagement
Points
Engagement
Type
Governance
Plan
Please describe how you will develop a governance plan for the project that articulates specific roles and responsibilities for the research team and stakeholder groups and defines rules for decision making, especially in the context of different opinions
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Dissemination Accelerating Components: Proposed Checklist (cont’d)
Describe how conflicts – true and perceived – will be managed
Describe how you will convey study results to stakeholders and study participants
Please describe how you will assess barriers and facilitators to incorporating the results into practice, beyond communicating the study results to stakeholders
Conflict
Management
Study
Results
Barriers
Assessment