Feds Announce Requirements Aimed at Providing more information about clinical trials to the public
The US Department of Health and Human Services (HHS) recently announced a final rule, which outlines new requirements for registering and recording certain clinical trials on its ClinicalTrials.gov website. At the same time, the National Institutes of Health (NIH) issued a policy for registering and submitting summary results for all NIH-funded trials.
“Access to more information about clinical trials is good for patients, the public and science,” said NIH Director Francis S. Collins, M.D., Ph.D. “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.”
Important elements of the final rule include:
- 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
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov
- Requiring additional types of adverse event information
- Providing a list of potential legal consequences for non-compliance
Read the news here.