Last week the National Institutes of Health and the U.S. Department of Health and Human Services (HHS) announced the release of a final rule on Clinical Trials Registration and Results Information Submission, and NIH also released a complementary Policy on the Dissemination of NIH-Funded Clinical Trial Information.
According to an NIH news release, the purpose of the final rule and policy is to make information about clinical trials widely available to the public. As NIH Director Dr. Francis Collins noted in a related blog post, clinical trial results have not always been publicly reported in a timely fashion.
Requirements under the final rule apply to most interventional studies of drug, biological and device products that are regulated by the FDA. The requirements do not apply to phase 1 trials of drug and biological products, or small feasibility studies of device products. The NIH policy applies to all NIH-funded trials, including phase 1 clinical trials of FDA-regulated products and small feasibility device trials as well as products that are not regulated by the FDA, such as behavioral interventions.