PCORI Teleconference/Webinar: Peer Review and Public Release of - - PowerPoint PPT Presentation

October 29, 2014 12:00 – 1:00 p.m. ET

PCORI Teleconference/Webinar: Peer Review and Public Release

• f PCORI’s Research Findings

Welcome

Joe Selby, MD, MPH Executive 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, MSPH Chief 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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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

• n 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.

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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, MSPH Chief Engagement and Dissemination Officer, PCORI Moderator

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Panel Members

Randy Burkholder Vice President of Policy and Research Pharmaceutical Research and Manufacturers of America Marc M. Boutin, JD Executive Vice President & Chief Operating Officer National Health Council Jonathan Finkelstein, MD, MPH Vice Chair for Quality and Outcomes Boston Children’s Hospital Andrew Sperling, JD Director of Federal Legislative Advocacy National Alliance on Mental Illness Wilson Pace, MD, FAAFP Director of the National Research Network American Academy of Family Physicians Phil Fontanarosa, MD, MBA Executive Editor The Journal of the American Medical Association Andy Womack, PhD Director, Science and Regulatory Affairs Biotechnology Industry Organization

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Patient/Caregiver Perspective

Marc M. Boutin, JD

Executive Vice President and Chief Operating Officer National Health Council

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Industry Perspective

Randy Burkholder

Vice President of Health Policy and Research Pharmaceutical Research and Manufacturers of America (PhRMA)

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Researcher Perspective

Jonathan Finkelstein, MD, MPH

Vice Chair for Quality and Outcomes Boston Children’s Hospital

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Medical Journal Perspective

Phil Fontanarosa, MD, MBA

Executive Editor The Journal of the American Medical Association (JAMA)

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Medical Society Perspective

Wilson Pace, MD, FAAFP

Director of the National Research Network American Academy of Family Physicians (AAFP)

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Patient/Caregiver Perspective

Andrew Sperling, JD

Director of Federal Legislative Advocacy National Alliance on Mental Illness

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Industry Perspective

Andy Womack, PhD

Director, Science and Regulatory Affairs Biotechnology Industry Organization

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Moderated Question and Answer Session

Jean Slutsky, PA, MSPH Chief Engagement and Dissemination Officer, PCORI Moderator

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Panel Members

Randy Burkholder Vice President of Policy and Research Pharmaceutical Research and Manufacturers of America Marc M. Boutin, JD Executive Vice President & Chief Operating Officer National Health Council Jonathan Finkelstein, MD, MPH Vice Chair for Quality and Outcomes Boston Children’s Hospital Andrew Sperling, JD Director of Federal Legislative Advocacy National Alliance on Mental Illness Wilson Pace, MD, FAAFP Director of the National Research Network American Academy of Family Physicians Phil Fontanarosa, MD, MBA Executive Editor The Journal of the American Medical Association Andy Womack, PhD Director, Science and Regulatory Affairs Biotechnology Industry Organization

PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings

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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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