PCORI Teleconference/Webinar: Peer Review and Public Release of PCORI’s Research Findings October 29, 2014 12:00 – 1:00 p.m. ET
Welcome Joe Selby, MD, MPH Executive Director, PCORI TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: 2 Peer Review and Public Release of PCORI’s Research Findings
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 TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: 3 Peer Review and Public Release of PCORI’s Research Findings
PCORI’s Purpose “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...” – from Patient Protection and Affordable Care Act TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 4
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 TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 5
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 TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 6
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. TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 7
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. TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 8
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: #PCORI PCORI 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 TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 10
Anticipated Timeline: Finalizing Proposed Process Task Date Board Vote to Approve Posting Proposal for 09/15/14 Public Comment Public Comment Period (54 Days) 09/15/14 – 11/7/14 Includes public event and webinar 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 TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 11
Timeline: Peer Review Process and Making Primary Research Findings Publicly Available PCORI Teleconference/Webinar, October 29, 2014: TWITTER: #PCORI 12 Peer Review and Public Release of PCORI’s Research Findings
Subset of Broader Dissemination and Implementation Plans TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 13
Panel Discussion with Patient, Caregiver, Researcher, Journal and Industry Representatives Jean Slutsky, PA, MSPH Chief Engagement and Dissemination Officer, PCORI Moderator TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 14
Panel Members Marc M. Boutin, JD Wilson Pace, MD, FAAFP Executive Vice President & Director of the National Research Chief Operating Officer Network National Health Council American Academy of Family Physicians Randy Burkholder Andrew Sperling, JD Vice President of Policy Director of Federal Legislative and Research Advocacy Pharmaceutical Research and National Alliance on Mental Illness Manufacturers of America Jonathan Finkelstein, MD, MPH Andy Womack, PhD Vice Chair for Quality and Director, Science and Regulatory Outcomes Affairs Boston Children’s Hospital Biotechnology Industry Organization Phil Fontanarosa, MD, MBA Executive Editor The Journal of the American Medical Association PCORI Teleconference/Webinar, October 29, 2014: 15 Peer Review and Public Release of PCORI’s Research Findings
Patient/Caregiver Perspective Marc M. Boutin, JD Executive Vice President and Chief Operating Officer National Health Council TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 16
Industry Perspective Randy Burkholder Vice President of Health Policy and Research Pharmaceutical Research and Manufacturers of America (PhRMA) TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 17
Researcher Perspective Jonathan Finkelstein, MD, MPH Vice Chair for Quality and Outcomes Boston Children’s Hospital TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 18
Medical Journal Perspective Phil Fontanarosa, MD, MBA Executive Editor The Journal of the American Medical Association (JAMA) TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 19
Medical Society Perspective Wilson Pace, MD, FAAFP Director of the National Research Network American Academy of Family Physicians (AAFP) TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 20
Patient/Caregiver Perspective Andrew Sperling, JD Director of Federal Legislative Advocacy National Alliance on Mental Illness TWITTER: #PCORI PCORI Teleconference/Webinar, October 29, 2014: Peer Review and Public Release of PCORI’s Research Findings 21
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