Process Designed to Ensure Validation and Broad, Timely Public Availability of Study Results
For Immediate Release
Patient-Centered Outcomes Research Institute
WASHINGTON, DC (Feb. 24, 2015) — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today adopted PCORI’s process for peer review and public release of the results of the comparative clinical effectiveness research (CER) studies it funds.
This process details how PCORI will meet its legislative mandate to ensure the scientific integrity of the primary research it supports and make study findings widely available and useful to patients, clinicians, and the general public within a specific timeframe. It is part of PCORI’s broader efforts to disseminate and implement research findings.
Read and download the Process for Peer Review of Primary Research and Public Release of Research Findings document.
The process document adopted by the Board reflects revisions made in response to comments provided by more than 60 individuals and organizations during a 54-day public comment period that followed PCORI’s release of a draft process document last September.
“The process for public release of research approved by PCORI’s Board of Governors today is the most transparent and comprehensive policy adopted by a major research funder to date,” said PCORI’s Executive Director Joe Selby, MD, MPH. “It includes release of both scientific and lay abstracts and publication of final reports, which will ensure that reliable, useful new clinical evidence reaches those who need it in ways that they can readily understand it and use it to make better-informed healthcare decisions.”
“Both the document we’ve approved today and the process by which PCORI developed and refined it underscore our commitment to open science and working collaboratively with the research and healthcare communities to meet our legislative mandates,” said Board Chairperson Grayson Norquist, MD, MSPH, Vice-Chair, Emory University Department of Psychiatry and Behavioral Sciences, and Chief of the Psychiatry Service at Grady Health System. “The approved process was enhanced by the many insightful and useful comments PCORI received from stakeholders during the public comment period, and we greatly appreciate all their helpful feedback.”
PCORI’s process aligns with others’, including those of federal agencies, in requiring registration of studies with appropriate web-based public registry sites and submission of results to the National Library of Medicine’s ClinicalTrials.gov site no more than 12 months after a study is completed.
PCORI’s peer review process will be based on the draft final reports that awardees are required to submit summarizing their projects. PCORI will oversee the review of these draft reports with input from subject matter experts and individuals with expertise on research methodology or biostatistics, as well as patients, caregivers, and other healthcare stakeholders.
After awardees have responded to reviewers’ comments to PCORI’s satisfaction, the report will be considered final. PCORI then will work with awardees to produce a 500-word abstract summarizing study results for medical professionals and a similar brief summary designed to make the results accessible and useful to patients and the general public. PCORI will post these materials on its website, along with anonymized reviewer comments, awardees’ responses, a link to a final results table on ClinicalTrials.gov, and other relevant information. Posting will occur no more than 90 days after PCORI accepts an awardee’s final report.
PCORI staff will now finalize a detailed implementation plan for the peer review and public release effort. This will include identifying one or more highly experienced contractors to assist with the process and working closely with PCORI’s awardees to be sure the various steps involved in the process are clear and appropriately incorporated into their project timelines.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.