The AAMC March 23 submitted a comment letter to the Department of Health and Human Services (HHS) regarding the Notice of Proposed Rulemaking (NPRM) published in the Nov. 21 Federal Register titled “Clinical Trials Registration and Results Submission” and the related draft policy issued by the National Institutes of Health (NIH) on dissemination of NIH-funded clinical trial information.
The HHS proposed rule clarifies and expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database for trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85). In particular, the proposed rule extends the FDAAA’s requirements to all applicable trials, not only those for which the drug or device has received FDA approval.
Released concurrently with the NPRM, NIH’s proposed policy applies reporting requirements to all NIH-funded clinical trials, regardless of study phase and whether or not they are subject to the FDAAA. The proposals aim to increase transparency and improve public access to clinical trials information.
AAMC has long supported the registration of clinical trials and was a leading proponent in 2004 of advancing ClinicalTrials.gov as the uniform, comprehensive national registry and results database for clinical studies.
In the letter, AAMC generally agrees with the expanded reporting requirements in both the NPRM and parallel policy, while encouraging the NIH to consider the following as it implements any resulting regulations:
- limitations or difficulty in using the existing ClinicalTrials.gov database;
- the extent of effort required to submit additional data in comparison with the perceived marginal benefit to patients and the research community;
- the alignment of incentives and obligations for faculty researchers, particularly with posting negative results, and;
- ensuring that the public-facing interface is both usable and clear in its utility and limitations.
The AAMC further urges “the NIH to use this opportunity to create an environment that supports effective, evidence-based regulation…(and) sees the current HHS proposed rule and the parallel NIH policy as part of the continuing effort to strengthen clinical trials by promoting transparency, trust, and usefulness of knowledge from human subjects research.”