About Us

As our funded research starts to produce findings of interest to patients, clinicians, payers, employers, industry, and other stakeholders, we are making plans for getting those results to those who need them. Our authorizing legislation directs us to peer-review the findings and make them publicly accessible within 90 days. We recently posted a draft plan for these activities and invited input during a public comment period. Now, we have analyzed the comments received and revised our process, which our Board of Governors adopted at its February 24 meeting.

What We Learned

We were pleased by the response that we received from our wide range of stakeholders. In addition to input provided at a public forum and webinar we hosted, our website received 63 submissions, with a total of 832 comments. Of those submissions, the greatest proportion came from researchers, followed by organizations representing patients and caregivers, and next, clinicians and clinician societies. 

Submissions by Stakeholder Group Chart

The commenters generally agreed with our proposed plan. Fifty-six percent said that it meets our obligations well, and only 6 percent said that it met them poorly. (Others indicated either a neutral position or provided no response.) Similarly, 59 percent indicated that the plan provides a clear understanding of the proposed process, compared to 6 percent saying it is unclear.

The respondents supported our decision to conduct peer review before providing results to the public, with 59 percent agreeing and only 8 percent disagreeing. The completion of peer review will mark the start of the 90 days to make the results publicly available, in response to the provision in the law that limits the time until public release of research findings. However, commenters asked for more clarity and detail on certain areas and expressed concern about the burden on awardees.

How We’ve Responded

Several major themes appeared in the comments, and we’ve recommended the changes indicated below. A multi-stakeholder advisory group confirmed the themes and reviewed the proposed revisions.

  • Stakeholder Engagement
    • Incorporate patients and other stakeholders into the peer review, lay-abstract preparation, and dissemination processes.
  • Review Process
    • Create a standardized approach for, and include details about, the selection of peer reviewers and for the peer-review process as a whole.
    • Include a clear set of standards regarding who is appropriate to provide scientific peer review and the basis of the scientific review.
    • Clarify the purpose and approach to the methodological review of the report.
    • Make the entire review process transparent so that reviewer comments and researcher responses are available to the public.
  • Lay Abstracts
    • Reduce the reading level of the lay abstracts to below eighth grade.
    • Intersection with Government Requirements and Scholarly Journals
      • Require that awardees post results tables to ClinicalTrials.gov before we begin our peer review, thus aligning our requirements with the Food and Drug Administration Amendments Act of 2007. 
      • Clarify how researchers can be assured that the publication of an abstract and table in ClinicalTrials.gov and the lay abstract on the PCORI website will not jeopardize publication in academic journals.
      • Establish a clear process for the resolution of potential differences between changes to a final report required by the PCORI peer review and those required by a journal review.
         
    • Dissemination and Implementation
    • Evaluation and Process Improvement
      • Require a formal evaluation of the policy in one year.


    Additionally, we worked closely with the National Institutes of Health to harmonize the policy with requirements outlined in Food and Drug Administration Amendments Act (FDAAA) of 2007.  This includes leveraging ClinicialTrials.gov by having awardees register projects on the database, as well as post results and generate results tables.

    Our next step will be to start implementing these activities with our existing awardees as they reach the end of their studies. We will also include these tasks in all future contracts to ensure that the high quality and broad availability of our research results makes them of greatest use in answering important questions for patients, clinicians, and other healthcare stakeholders. 

    The final analysis of the public comments and a table of our responses is available here.  

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