- The PCORI Strategic Plan
- Our Programs
- Our Vision & Mission
- Financial Statements and Reports
- The PCORI Strategic Plan
- Board of Governors
- Methodology Committee
- Authorizing Law
- Evaluating Our Work
- PCORI's Advisory Panels
- Procurement Opportunities
- Draft Key Questions: Systematic Review of the Impact of Doula Support During Pregnancy, Childbirth and Beyond (2024)
Past Opportunities to Provide Input
- Patient-Centered Economic Outcomes Landscape (2023-2024)
- Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023) -- Draft Key Questions
- Proposed New Methodology Standards for Usual Care as a Comparator (2023)
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
As a major funder of comparative clinical effectiveness research—with more than $2.8 billion awarded to support more than 1,700 research and related projects—PCORI holds a strong commitment to increase the public availability of clinical research findings. After research concludes, physicians and policy makers depend on peer-reviewed publications to access clinical trial findings they can implement in their practice and decision making.
Unfortunately, study results are often not shared publicly in a timely way. Analyses have found that only 60 percent of clinical trials have published results even five years after completion. Further, null findings—when the effect of a tested intervention is no different than an alternative—are less likely to be published, which contributes to publication bias and an overestimation of an intervention’s effectiveness. Efforts in the United States have sought to improve the scientific integrity of clinical trial results reporting, such as the requirement for registering and reporting results to ClinicalTrials.gov, but this remains a challenge for the research community.
We’re proud to see that our peer review and posting efforts have sped up the process for results reporting, without hindering studies that want to publish their results later.
PCORI has been a leader in the conversation on open science and the effort to provide broader and more meaningful public and professional access to the results and data from clinical research. We have built a robust peer-review process for our funded research and post results on our website in patient- and clinician-friendly abstracts, whether the results are positive or negative. A full final research report, about the same as the content of three to five journal publications, is posted within 12 months of completion of PCORI peer review. We also encourage awardees to publish in peer-reviewed journals, and PCORI covers the costs associated with open access for papers sharing primary results.
In an analysis of our early cohorts of completed clinical trials, we found that the time for our funded trials to make results available to the public is substantially shorter than available benchmarks for similar research funded by other organizations. Of the 224 trials that had completed participant recruitment and follow-up, 196 had results publicly available at the time of our analysis and 28 trials were still undergoing peer review. Sixty-five percent of trials with results available had results published and 95 percent of trials had results available through abstracts posted to our website.
Thirty-two percent of results were first made available through publication and 68 percent were first made available via results abstracts posted to the PCORI website. Among studies that first had results available via results abstract, 48 percent have also subsequently published results in the literature. To compare our performance directly with the available benchmark for other funders (60 percent of studies with results publicly available by 60 months), PCORI reached 60 percent of results publicly available within 19 months. Overall, 100 percent of our funded trials had their results available to the public by 36 months.
This analysis shows that our robust efforts to track every publication associated with studies we fund have allowed us to evaluate our contributions to the field as a research funder. We’re proud to see that our peer review and posting efforts have sped up the process for results reporting, without hindering studies that want to publish their results later. We’re also proud of our commitment to the transparency and openness that underlie our work to ensure patients and the public have the information they need to make the most informed healthcare decisions they can.
Our website features a searchable database of journal publications, articles, and commentaries highlighting studies we’ve funded and the work we do. Visitors can also search our full portfolio and filter for research projects that have results abstracts posted.
Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2012;344:d7292. doi:10.1136/bmj.d7292. 22214755