On September 16, 2016, in an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services (HHS) issued a final rule specifying requirements for registering and reporting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for certain clinical trials involving U.S. Food and Drug Administration (FDA)-regulated drug, biological and device products to ClinicalTrials.gov. At the same time, the National Institutes of Health issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded clinical trials, including those not subject to the final rule. These actions are important steps to honor our commitments to clinical trial participants to share the knowledge gained from their participation in order to achieve the greatest benefit to human health.
Since many of you are likely to be affected by these changes, we encourage you to read the NIH news release along with related materials to learn more about these important developments.