To make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services (HHS) issued a final rule on September 19 that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration (FDA)-regulated drug, biologic, and device products. At the same time, the National Institutes of Health (NIH) 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.
Francis S. Collins, MD, PhD
“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD. “The final rule and NIH policy we have issued 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.”
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 health-care 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, biologic, and device products that are regulated by the FDA. The requirements do not apply to phase I trials of drug and biologic 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.
Robert M. Califf, MD
“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,” said FDA Commissioner Robert M. Califf, MD. “The FDA will help ensure compliance with these new requirements, so patients and providers can have confidence in and access to significantly more clinical trial information, and researchers can improve clinical trial focus and design.”
Final Rule Components
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 the following:
- 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;
- Providing a list of potential legal consequences for noncompliance. ■
