In comments on proposed changes governing the registration and reporting of clinical trial results, the Federation of American Societies for Experimental Biology (FASEB) noted the importance of having standardized, transparent, and publicly available information about clinical trials available to avoid unintended duplication of studies and detect adverse events. FASEB also raised concerns about certain aspects of the proposed changes in its response to a notice of proposed rulemaking from the Department of Health and Human Services (HHS) and a proposed companion policy issued by the National Institutes of Health (NIH).
Established by the 1997 Food and Drug Administration Modernization Act (FDAMA), the ClinicalTrials.gov website serves as the primary source of information regarding publicly and privately supported clinical studies involving human participants worldwide. In November 2014, HHS issued a Notice of Proposed Rulemaking (NPRM) to expand the requirements for registering and submitting data on the outcomes of clinical trials in an effort to enhance information sharing, reduce duplicative efforts, and ultimately, improve public health. Although Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) already requires registration and reporting of clinical trial results for FDA-approved drugs, biological products, and devices, the NPRM would expand this to include “controlled” interventional studies of FDA-regulated drugs, biological products, and devices.
In conjunction with the release of the HHS NPRM, NIH released a proposed companion policy to require the registration and reporting of results for all NIH-funded clinical studies, including Phase 1 and others not covered by FDAAA, on the ClinicalTrials.gov site. These changes are intended to enhance patient enrollment, provide the means to track progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials.
In its comments, FASEB raised several concerns with both the NPRM and the proposed NIH policy. Two of these concerns related to capacity. One relates to the staff and digital resources of the National Library of Medicine (which hosts ClinicalTrials.gov site) to accommodate the anticipated influx of users and data uploads that would accompany the proposed changes. The other concerns the ability of institutions and clinical research teams with limited resources to fulfill the new reporting requirements and deadlines. FASEB’s comments also highlighted the need for more collaborative rather than punitive measures to ensure data sharing, the risks of premature interpretation of trial outcomes, and a need for more attention to patient privacy and risks for re-identification of human subjects. In recognition of these issues, FASEB recommended that HHS either delay finalization of the rule or amend the NPRM to accommodate a transition period during which additional resources would be provided to facilitate compliance.
In addition to the broad concerns raised in response to the HHS NPRM, FASEB questioned the utility of expanding clinical trial reporting to Phase 1 trials as proposed in the NIH policy. FASEB specifically highlighted the potential for misinterpretation of studies designed to determine safety (Phase 1) versus those to assess efficacy (Phase 2 or 3) by patients and physicians. Therefore, FASEB urged NIH to exclude Phase 1 clinical trials from the final policy or limit data reporting for Phase 1 trials to adverse events. HHS and NIH will accept comments on the NPRM and companion policy through March 23, 2015.