NIH proposes tougher clinical trial reporting requirements
All NIH-funded studies would be required to register
The National Institutes of Health (NIH) is beefing up its reporting requirements for completed clinical trials.
The agency’s Notice of Proposed Rulemaking (NPRM), released in November, expands clinical trial registration and reporting guidelines for clinical trials that are required to register with ClinicalTrials.gov under the U.S. Food and Drug Administration Amendments Act (FDAAA). Currently under the act, certain research studies and clinical trials involving human subjects must register with ClinicalTrials.gov and publish the trial results on the website and/or in a scientific journal within one year of completion. However, studies have shown that registered trial data is incomplete, unpublished, or slow to be published. (For more coverage on these studies, see the January 2014 issue of IRB Advisor, page 11, and the September 2014 issue, page 106.) The NIH also proposed a draft policy to require that all clinical trials that receive full or partial NIH finding be required to register.
"ClinicalTrials.gov currently contains registration information for more than 178,000 clinical trials and summary results for more than 15,000," according to a statement from NIH. "These numbers include trials that are not subject to FDAAA. Among the primary benefits of registering and reporting results of clinical trials, including both positive and negative findings, is that it helps researchers prevent unnecessary duplication of trials, particularly when trial results indicate that a product under study may be unsafe or ineffective, and it establishes trust with clinical trial participants that the information from their participation is being put to maximum use to further knowledge about their condition," according to the statement.
Noteworthy changes
Major changes in the NPRM include the following:
Registration of all NIH-funded studies — even those receiving partial funding — regardless of study phase or intervention. Currently, wholly NIH-funded studies of FDA-approved products are required to be registered to ClinicalTrials.gov within 21 days of enrolling the first subject.
Studies on non-FDA approved products are required to register.
Expansion of data elements required for registration, including "data elements that are necessary to implement other provisions of the law, provide more complete descriptions of the clinical trial and the intervention(s) studied, and indicate the status of human subjects protection review for the clinical trial," according to the notice. Currently, descriptive information, recruitment information, location and contact information, and administrative information are required.
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For drugs available under expanded access, the responsible party would be required to submit a separate expanded access record with details on how to obtain access to the drug.
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Submission of study summary results within a year of trial completion, regardless of whether the drug, biologic, or device received FDA approval; however, summary results can be delayed for two additional years if the unapproved article is still being developed by the manufacturer, or if the sponsor will seek a new use for the article. Right now, only articles that receive FDA approval are required to have summary results.
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Expansion of the scope of information to be included in the summary results, including chart and table information (for example, two data tables are now required to show adverse event information).
Submitted trial information must be updated at least once a year if anything changes, and any errors must be promptly corrected.
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The NIH will post submitted results information no later than 30 days after submission to ClinicalTrials.gov.
"This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices and biological products available to the public," said FDA Commissioner Margaret A. Hamburg, MD, in a statement. "It would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products."
Public comment for the NPRM is open until February 19, 2015. Highlights from the NPRM can be read at http://www.nih.gov/news/health/nov2014/od-19_summary.htm while the rule in its entirety can be found at http://ofr.gov/OFRUpload/OFRData/2014-26197_PI.pdf.
