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-regulated drug, biological and device products. At the same time, the National Institutes of Health has issued 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.

"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."

Clinical trials are vital to medical advances because they test new and existing health-related interventions, helping us understand whether they are safe and effective in humans when used as intended. Some clinical trials provide information about which medical treatments work best for certain illnesses or certain groups of people.

Expanding the registration information in ClinicalTrials.gov improves people's ability to find clinical trials in which they may be able to participate and access investigational therapies.

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