HHS Issues Final Rule on Clinical Trial Transparency
19 September 2016
The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological and device products.
In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services has issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. At the same time, the National Institutes of Health has issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.
“Access to more information about clinical trials is good for patients, the public and science,” said NIH Director Francis S. Collins, M.D., Ph.D. “The final rule and NIH policy we have issued today 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.”
Clinical trials are vital to medical advances because they test new and existing health-related interventions, helping us understand whether they are safe and effective in humans when used as intended. Some clinical trials provide information about which medical treatments work best for certain illnesses or certain groups of people.
Expanding the registration information in ClinicalTrials.gov improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies. More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study and improve study designs, ultimately advancing the development of clinical interventions.
Requirements under the final rule apply to most interventional studies of drug, biological and device products that are regulated by the FDA. The requirements do not apply to phase 1 trials of drug and biological products, or 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. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.
“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 healthcare providers, as well as researchers,” said FDA Commissioner Robert M. Califf, M.D. “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 final rule was informed by nearly 900 comments received during the public comment period on the Notice of Proposed Rulemaking and the National Library of Medicine's many years of experience with managing and operating ClinicalTrials.gov. 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.
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.
HHS values the public’s participation in clinical trials and the knowledge gained by their participation; considers it an obligation to support the maximal use of this knowledge for the greatest benefit to human health; and strongly supports sharing of clinical trial summary data to allow the broader scientific research community to use and build upon clinical trial findings.
The Office of the Director is responsible for setting policy for NIH, which includes 27 Institutes and Centers. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at https://www.nih.gov/institutes-nih/nih-office-director.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.