We have written several blogs and articles over the past two years about our efforts to enhance stewardship and transparency in clinical trial research. Indeed, earlier this year Congress applauded our efforts thus far and reaffirmed its commitment to ensuring public access to the results of the NIH-funded clinical trials through timely registration and results information reporting on ClinicalTrials.gov. However, we have heard concern about how the NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to fundamental studies involving human participants.
A few days ago we issued a Request for Information (RFI) seeking input on the standards NIH should use in assuring adequate registration and results information reporting for the subset of studies that meet NIH’s definition of a clinical trial and that focus on basic research. We are referring to these studies as “prospective basic science studies involving human participants.”
Specifically, the RFI seeks comments on the following:
- Specific examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov, including specific reasons for these challenges (e.g., specific data elements);
- Strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants;
- Additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants;
- Other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; and
- Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants.
We encourage respondents to review ClinicalTrials.gov registration and results submission requirements as described in the PRS User’s Guide to ensure that responses are as informed, specific, and actionable as possible. Of note, as of August 15, 2018, ClinicalTrials.gov contains over 10,000 interventional study records listing “basic science” as the primary purpose.
All responses should be submitted electronically by November 12, 2018. Please note that while we always welcome comments in response to blog posts, official comments should be submitted following the guidance in the RFI to ensure their appropriate consideration.