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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

HHS Proposes Changes in Registering, Reporting Results from Clinical Trials

November 21, 2014—The National Institutes of Health (NIH) and Department of Health and Human Services (HHS) issued a Nov. 19 Notice of Proposed Rulemaking (NPRM) proposing changes in regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85).

The proposed rule clarifies the requirement to register clinical trials and report summary trial results to ClinicalTrials.gov. It applies to certain interventional studies of drugs, biological products, and devices that are regulated by the Food and Drug Administration (FDA), but generally not to phase 1 trials of drugs and biological products and small feasibility studies of devices.

Concurrent with the NPRM, NIH issued a request for comments on the draft policy on Dissemination of NIH-Funded Clinical Trial Information. NIH’s proposed policy will apply the results reporting requirements to all NIH-funded clinical trials, regardless of study phase and whether or not they are subject to the FDAAA.

Both documents propose an expansion of the scope of clinical trials registration and reporting by requiring the submission of summary results to include trials of unapproved, unlicensed, and uncleared products. Agency representatives have noted that specifying the timelines for trials’ registration and result submission will make it easier to enforce compliance with the rule. A summary of proposed changes is available on the NIH website.

Comments to the NPRM can be submitted to www.regulations.gov and comments on the draft NIH policy can be submitted via email to clinicaltrials.disseminationpolicy@mail.nih.gov. All comments are due by Feb. 19, 2015.

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

Irena Tartakovsky, M.D.
Director, Constituent Engagement
Telephone: 202-862-6134
Email: itartakovsky@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org