In a move to make government sponsored clinical trials publicly known and easily found, the Department of Health and Human Services (HHS) announced a new process for submitting and releasing clinical trials on the government's new clinical trials website
“Access to more information about clinical trials is good for patients, the public and science,” National Institute of Health director, Francis S. Collins, MD, PhD, said. “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.” The National Institute of Health has posted the new rules for clinical trials on its website.
While this is a strong step toward transparency, according to the NIH the new rules do not “dictate how clinical trials should be designed or conducted, or what data must be collected.” With more than 900 submitted comments, the final rule includes these provisions:
- 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 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 healthcare providers, as well as researchers,” U.S. Food and Drug Administration commissioner Robert M. Califf, MD said of the changes.