September 15, 2016

HHS Final Rule and NIH Policy on Clinical Trials Reporting – Dr. Francis Collins, NIH

In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services today issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration (FDA)-regulated drug, biological and device products. Dr. Francis Collins, Director of the National Institutes of Health, talks about NIH issuing a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

This page last reviewed on September 26, 2016