The US Department of Health and Human Services (HHS) has issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information.
This move will make more information about clinical trials involving the US Food and Drug Administration-regulated drug, biological and device products widely available to the public.
At the same time, the National Institutes of Health (NIH) has issued a complementary policy for registering and submitting summary results information to the same site – ClinicalTrials.gov – for all NIH-funded trials, including those not subject to the final rule.
NIH director Francis Collins said: “Access to more information about clinical trials is good for patients, the public and science. 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.”
The expansion of 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 may also 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. They do not apply to Phase I trials of drugs and biological products, or small feasibility studies of device products.
The final rule does not dictate how clinical trials should be designed or conducted, or what data must be collected.
FDA Commissioner Robert Califf added: “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.
“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 I clinical trials of FDA-regulated products and small feasibility device studies as well as products that are not regulated by the FDA, such as behavioral interventions.