The Proposed Rule for U.S. Clinical Trial Registration and Results Submission

Abstract

Broad access to information about clinical trials and their findings is critical for advancing medicine, promoting public health, and fulfilling ethical obligations to human volunteers. Traditional methods of information dissemination (e.g., presentations and publication) may nevertheless leave distortions and gaps in the knowledge base because the results of many trials are not published. Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) addressed some of these concerns by requiring the registration and submission of summary results information to ClinicalTrials.gov for certain clinical trials of drugs (including biologic products) and devices. The Department of Health and Human Services (HHS) recently published for public comment a proposed rule (or “Notice of Proposed Rulemaking [NPRM] for Clinical Trials Registration and Results Submission”) to clarify and expand (as permitted) the FDAAA requirements and ultimately facilitate compliance with the law. Separately, and in keeping with a long-standing principle that systematic dissemination of results is a critical step in realizing the value of the research investment, the National Institutes of Health (NIH) has issued a draft policy for public comment to promote registration and results submission to ClinicalTrials.gov. This policy is proposed to cover all NIH-funded clinical trials, regardless of study phase, type of intervention, or whether they are subject to the FDAAA requirements. In this article, we provide information about the FDAAA and NPRM to encourage the research community to submit comments on the proposed rule at www.regulations.gov/#!docketDetail;D=NIH-2011-0003. Comments submitted before February 19, 2015, will be considered in formulating the final rule.