HHS introduces final rule to increase access to clinical trials

The U.S. Department of Health and Human Services (HHS) has announced a final rule to make information about clinical trials more accessible to the public. The National Institutes of Health (NIH) has also announced a complementary policy for the registration and submission of results to ClinicalTrials.gov for all NIH-funded trials.

Making clinical trials more available to the public increases awareness for possible participants in the studies and accessibility about certain findings. By submitting the information and results of studies to a single site, researchers can avoid holding trails that are too similar and could potentially lead to the same results.

“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, MD. “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 gives specific requirements for the registration of certain clinical trials and the submission of results to ClinicalTrials.gov and expands the legal requirements for U.S. Food and Drug Administration (FDA)-regulated drugs and devices.

The final rule includes:

• A checklist of which trails have regulations and who is in charge of submitting required information.
• Expanding the number of trails where the information must be submitted to include trails of FDA regulated products that have not yet been approved.
• Additional registration details and results, including race and the ethnicity of participants, need to be submitted to ClinicalTrials.gov.
• A list of legal consequences for non-compliance.
• Requiring more types of information on adverse events.

“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 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.”