New rules on registering and reporting clinical trials

By | September 22, 2016

The Department of Health and Human Services (HHS) issued new rules on announcing clinical trials and reporting their results. On September 16, HHS released the Final Rule on clinical trials registration and summary results information submission on the website.

The Final Rule mirrors the Notice of Proposed Rulemaking (NPRM) published in November 2014. At the time, the Federation of American Societies for Experimental Biology (FASEB) submitted comments and concerns about the scope, implementation, monitoring, and enforcement of the proposed changes to the regulations. While acknowledging concerns from FASEB and other stakeholders, the Final Rule includes the data field requirements, timelines for posting, and potential punitive measures originally set forth in the NPRM.

HHS published a summary of changes from current practice to clarify which trials need to register and what information they need to report under the new rules. More information on the HHS regulation and background on some of the key issues can be found in an article in the New England Journal of Medicine.

Coincident with the HHS announcement, the National Institutes of Health (NIH) released a companion policy for reporting any NIH-funded trial, regardless of whether it meets the criteria for reporting under the HHS rule, to Namely, Phase 1 clinical trials, which are excluded from the HHS Rule, must register and report results if they are funded in part or in full by NIH. NIH published a chart to compare and contrast major elements of the HHS and NIH policies.

NIH will require all investigators and staff involved in the conduct and managements of clinical trials to receive training on Good Clinical Practice (see Notice NOT-OD-16-148), and, beginning September 27, 2017, will only accept funding applications for clinical research submitted through Funding Opportunity Announcements specifically designed for clinical trials (see Notice NOT-OD-16-147). More information on the NIH policies can be found on the NIH Office of Science Policy blog, the NIH Director’s blog, and a commentary in the Journal of the American Medical Association.

As these policies are final, there is no public comment period. Both the NIH Policy and HHS Final Rule will take effect on January 18, 2017.