WASHINGTON, Sept. 16 (UPI) — In an effort to increase awareness of clinical trials and their results, the National Institutes of Health and U.S. Department of Health and Human Services today released new rules requiring more information about trials and how to join them, as well as greater requirements for the results of such trials.
The new HHS rule applies to all clinical trials, which are listed at the website ClinicalTrials.gov and include drugs or devices that fall into product areas regulated by the U.S. Food and Drug Administration. The NIH rule is specific to all trials funded by the agency and carries greater requirements.
“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,” Dr. Robert Califf, commissioner of the FDA, said in a press release. “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 HHS rule requires: providing a checklist for evaluating which trials are subject to regulations and who is responsible for submitting information; larger scope of trials thatl require summary results to be submitted for products not yet approved by the FDA; additional registration and summary result information submitted to ClinicalTrials.gov; more information on adverse health events. The rule also includes a list of potential legal consequences for not following the new regulation.
The NIH, which provides about $3 billion per year in funding for clinical trials, plans to increase requirements for all trials, including phase 1 clinical trials, which are typically related to safety, and small feasibility device trials. Neither is included in the new HHS requirements.
The regulations NIH is expanding to all trials it funds is meant to make sure the agency’s work is being conducted properly, with Dr. Kathy Hudson and Dr. Francis Collins writing in a blog post today that the agency will start extensive outreach and work with researchers to ensure the new requirements are met.
“Access to more information about clinical trials is good for patients, the public and science,” Collins, director of the NIH, said in a press release. “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.”
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