On November 19, the National Institutes of Health (“NIH”) announced the release of two proposals to increase public access to clinical trials through the submission of information to ClinicalTrials.gov. ClinicalTrials.gov is a public database operated and maintained by the National Library of Medicine of NIH that provides information on publicly and privately funded clinical trials testing the safety and efficacy of drugs in human participants. The two proposals are intended to increase the public’s access to clinical trials, which will help inform future research activities, improve the design of future studies, prevent duplicative trials, and enhance transparency and trust in clinical trials.

The first of NIH’s proposals is a proposed rule promulgated pursuant to the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). According to NIH, the FDAAA generally applies to controlled, interventional studies of FDA-regulated drugs, biologics, and devices. The FDAAA generally requires certain minimal information about applicable clinical trials to be submitted to ClinicalTrials.gov, which can be accessed and searched by the general public. 

The proposed rule proposes requirements for registration and submission of summary results information for certain clinical trials of drugs, biologics, and devices and pediatric post-market surveillance of devices ordered by the FDA, excluding Phase I trials of drugs and biologics and small feasibility studies of devices. The proposed requirements will apply to the trial sponsor or designated principal investigator for such applicable clinical trials. According to NIH, the notable changes and requirements in the proposed rule include:

  • An approach to determine whether a clinical trial is subject to the proposed rule;
  • An approach for identifying parties responsible for registering clinical trials on ClinicalTrials.gov and for submitting required data;
  • Expanding requirements for reporting summary trial results to include trials of unapproved products;
  • Requiring additional data elements at the time of registration with ClinicalTrials.gov and when submitting summary results; 
  • Clarification of procedures for delayed submission of results for certain trials; 
  • Requiring an update of certain data elements to ensure ongoing accuracy of information available on ClinicalTrials.gov; and 
  • Procedures to correct data errors in a timely manner. 

The second proposal announced by NIH is a proposed policy that would extend the registration and reporting requirements of the FDAAA to all clinical trials that receive funding from NIH, regardless of whether the trials are subject to the FDAAA. Currently, NIH awardees are required to publicize their study results, but are not required to register with and submit data to ClinicalTrials.gov unless the trial falls within the requirements of the FDAAA. NIH-funded trials will be required to comply with the FDAAA registration and reporting requirements and the proposed rule, when finalized. Compliance with the proposed policy will be a condition to receiving NIH grants. 

NIH is seeking public comments on both the proposed rule and proposed policy.