The Department of Health and Human Services (HHS) Sept. 16 issued the final rule on clinical trials registration and results submission, specifying new requirements and expanding the scope and application of the regulation for the submission of trial data to the ClinicalTrials.gov website.
Among the provisions in the final regulation are: requiring the submission of additional data elements from studies to ClinicalTrials.gov, including the full protocol, race and ethnicity of trial participants (if collected), and additional types of adverse event information.
The rule also states that summary results information must be submitted from a greater number of trials, including those involving Food and Drug Administration (FDA) regulated products that have not yet been approved, licensed, or cleared by the FDA. A complementary policy released by the NIH at the same time requires summary results reporting for all clinical trials funded in whole or part by NIH, regardless of study phase, type of intervention, or whether they are subject to the Final Rule.
The AAMC previously submitted a response to the proposed HHS rule and draft NIH policy expressing support for sharing results from clinical studies, but urging NIH to consider challenges in implementing the rule, including limitations or difficulty in using the existing ClinicalTrials.gov database and ensuring that the public-facing interface is both usable and clear [see Washington Highlights, March 27, 2015].
In a press release, NIH Director Francis S. Collins, M.D., Ph.D., stated, “Access to more information about clinical trials is good for patients, the public and science. The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”
The final rule will be effective Jan. 18, 2017. As of that date, the ClinicalTrials.gov system will be updated to allow for compliance with the new requirements. Investigators will then have 90 days to come into compliance with the regulation.