October 29, 201412:00 – 1:00 p.m. ET
PCORI Teleconference/Webinar: Peer Review and Public Release of PCORI’s Research Findings
Welcome
Joe Selby, MD, MPHExecutive Director, PCORI
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Presentation on PCORI’s Proposed Process for Peer Review and Public Release of Its Primary Research Findings
Jean Slutsky, PA, MSPHChief Engagement and Dissemination Officer, PCORI
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“The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis...and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services...”
PCORI’s Purpose
– from Patient Protection and Affordable Care Act
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PCORI’s Obligations Under its Authorizing Legislation
Conduct Peer Review of Primary Research Assess scientific integrity Assess adherence to PCORI’s Methodology Standards
Release of Research Findings No later than 90 days after “conduct or receipt” Make available to clinicians, patients, and general public Make comprehensible and useful to patients and providers for
healthcare decisions Include considerations specific to certain subpopulations, risk
factors, and comorbidities Describe process and methods, including conflicts of interest Include limitations and further research needed
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Challenges
Conduct Peer Review of Primary Research Typically handled by journals as part of publishing process Often takes longer than 90 days Doesn’t routinely consider adherence to PCORI’s
Methodology Standards
Release of Primary Research Findings Might affect researchers’ opportunity to publish in a journal
by constituting “prior publication” Our process and traditional publishing process might yield
different interpretations of a study’s results
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TWITTER: #PCORIPCORI Teleconference/Webinar, October 29, 2014:Peer Review and Public Release of PCORI’s Research Findings
PCORI’s Proposal for Peer Review
1. Registration. PCORI research projects must be registered at the site appropriate to study design: ClinicalTrials.gov, Registry of Patient Registries (RoPR), PROSPERO.
2. Draft Final Report. Awardee Institution submits draft final report to PCORI for peer review three months after completion of data analysis specified in the research protocol, which will be set in the milestones.
3. PCORI Peer Review. PCORI manages peer-review of final report using a combination of staff and contracted resources.
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Components of Final Report
Description of Main Study Results— Methods; Results; Sub-populations, risk factors, comorbidities; Limitations; Needed further research; Tables; Conclusions.
Abstract— 500-word limit; for medical professionals.
Results Table— Summarizes key findings; for submission to ClinicalTrials.gov (or other site) and PCORI.org.
Ancillary Information— Identifies entity and investigators conducting research and discloses conflicts of interest.
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PCORI’s Proposal for Making Research Findings Publicly Available
1. Information for Various Audiences. After PCORI accepts final report, PCORI, with approval of Awardee Institution, will:
• produce a summary of the abstract, results table, and ancillary information to “convey the findings of research in a manner that is comprehensible and useful to patients and providers in making health care decisions.”
2. Public Posting on PCORI.org and Submission to ClinicalTrials.gov. Within 90 days of PCORI’s acceptance of final report:• PCORI will post information for patients and consumers to PCORI.org • Awardee Institution will ensure that results table is submitted to
ClinicalTrials.gov (or other site) and ensure that links to abstracts posted on PCORI.org are provided.*
* For applicable clinical trials regulated under FDAAA, there may be instances when the results table is submitted to ClinicalTrials.gov before PCORI peer-review is completed.
TWITTER: #PCORIPCORI Teleconference/Webinar, October 29, 2014:Peer Review and Public Release of PCORI’s Research Findings 9
Management Plan
Issue Request for Proposal to select contractor to help manage peer review process
Recruit and hire peer review manager
Use industry-standard editorial processing/peer review software system and retain scientific methodologist
Program Officers work with peer review manager to reconcile reviewer comments and revisions in final report
Retain contractor to prepare information for patient and consumer audiences
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Anticipated Timeline:Finalizing Proposed Process
Task Date
Board Vote to Approve Posting Proposal for Public Comment 09/15/14
Public Comment Period (54 Days)Includes public event and webinar
09/15/14 – 11/7/14
Analyses and Synthesis Period 11/10/14 – 12/31/14
Analyses Report Due to PCORI 01/10/15
Strategy Committee Review Period 01/16/15 – 02/17/15
Board Vote on Revised Draft 02/24/15
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Timeline: Peer Review Process and Making Primary Research Findings Publicly Available
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Subset of Broader Dissemination and Implementation Plans
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Panel Discussion with Patient, Caregiver, Researcher, Journal and Industry Representatives
Jean Slutsky, PA, MSPHChief Engagement and Dissemination Officer, PCORI Moderator
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Panel Members
Randy BurkholderVice President of Policy and ResearchPharmaceutical Research and Manufacturers of America
Marc M. Boutin, JDExecutive Vice President & Chief Operating OfficerNational Health Council
Jonathan Finkelstein, MD, MPHVice Chair for Quality and OutcomesBoston Children’s Hospital
Andrew Sperling, JDDirector of Federal Legislative AdvocacyNational Alliance on Mental Illness
Wilson Pace, MD, FAAFPDirector of the National Research NetworkAmerican Academy of Family Physicians
Phil Fontanarosa, MD, MBAExecutive EditorThe Journal of the AmericanMedical Association
Andy Womack, PhDDirector, Science and Regulatory AffairsBiotechnology Industry Organization
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Patient/Caregiver Perspective
Marc M. Boutin, JDExecutive Vice President and Chief Operating Officer National Health Council
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Industry Perspective
Randy BurkholderVice President of Health Policy and Research Pharmaceutical Research and Manufacturers of America (PhRMA)
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Researcher Perspective
Jonathan Finkelstein, MD, MPHVice Chair for Quality and OutcomesBoston Children’s Hospital
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Medical Journal Perspective
Phil Fontanarosa, MD, MBAExecutive EditorThe Journal of the American Medical Association (JAMA)
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Medical Society Perspective
Wilson Pace, MD, FAAFPDirector of the National Research NetworkAmerican Academy of Family Physicians (AAFP)
TWITTER: #PCORIPCORI Teleconference/Webinar, October 29, 2014:Peer Review and Public Release of PCORI’s Research Findings 20
Patient/Caregiver Perspective
Andrew Sperling, JDDirector of Federal Legislative AdvocacyNational Alliance on Mental Illness
TWITTER: #PCORIPCORI Teleconference/Webinar, October 29, 2014:Peer Review and Public Release of PCORI’s Research Findings 21
Industry Perspective
Andy Womack, PhDDirector, Science and Regulatory AffairsBiotechnology Industry Organization
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Moderated Question and Answer Session
Jean Slutsky, PA, MSPHChief Engagement and Dissemination Officer, PCORI Moderator
TWITTER: #PCORIPCORI Teleconference/Webinar, October 29, 2014:Peer Review and Public Release of PCORI’s Research Findings 23
Panel Members
Randy BurkholderVice President of Policy and ResearchPharmaceutical Research and Manufacturers of America
Marc M. Boutin, JDExecutive Vice President & Chief Operating OfficerNational Health Council
Jonathan Finkelstein, MD, MPHVice Chair for Quality and OutcomesBoston Children’s Hospital
Andrew Sperling, JDDirector of Federal Legislative AdvocacyNational Alliance on Mental Illness
Wilson Pace, MD, FAAFPDirector of the National Research NetworkAmerican Academy of Family Physicians
Phil Fontanarosa, MD, MBAExecutive EditorThe Journal of the AmericanMedical Association
Andy Womack, PhDDirector, Science and Regulatory AffairsBiotechnology Industry Organization
PCORI Teleconference/Webinar, October 29, 2014:Peer Review and Public Release of PCORI’s Research Findings 24
Submit Your Public Comment
Peer review and public release of PCORI’s research findings public comment period closes: Friday, November 7, 11:59 p.m. ET
Submit comments: PCORI.org/content/provide-input
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Thank you
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