The U.S. Department of Health and Human Services issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results to clinicaltrials.gov. The rule comes as an effort to make information about clinical trials widely available to the public, according to a press release from the NIH.
“Access to more information about clinical trials is good for patients, the public and science,” Francis S. Collins, PhD, NIH director, said in the release. “The final rule and NIH policy [will] help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”
The new rule expands legal requirements for the submission of registration and results information for clinical trials involving FDA-regulated drug, biological and device products. In addition, the NIH issued a complementary policy for the registration and submission of summary results information to clinicaltrials.gov for all NIH-funded trials, including those not subject to the final rule.
Requirements under the final rule apply to most interventional studies of drug, biological and device products regulated by the FDA, the release noted. The requirements do not apply to phase 1 trials of drug and biological products or to small feasibility studies of device products. The final rule specifies how and when information collected in a clinical trial must be submitted to clinicaltrials.gov, according to the release; however, it does not dictate how clinical trials should be designed or conducted, or what data must be collected.
The final rule was informed by nearly 900 comments received during the public comment period and by the experience of the National Library of Medicine with managing and operating clincialtrials.gov. According to the release, important elements of the final rule include:
- providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information;
- expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed or cleared by the FDA;
- requiring additional registration and summary results information data elements to be submitted to clinicaltrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol;
- requiring additional types of adverse event information; and
- providing a list of potential legal consequences for non-compliance.
“When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their health care providers, as well as researchers,” FDA Commissioner Robert M. Califf, MD, MACC, said in the release. “The FDA will help ensure compliance with these new requirements so that patients and providers can have confidence in and access to significantly more clinical trial information, and researchers can improve clinical trial focus and design.”
The NIH policy applies to all NIH-funded trials, including phase 1 clinical trials of FDA-regulated products and small feasibility device trials as well as products that are not regulated by the FDA, such as behavioral interventions, the release noted.
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