ClinicalTrials.gov is a Web-based resource created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of Health and Human Services (HHS), through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions. NIH and the Food and Drug Administration (FDA) worked together to develop the site, which was made available to the public in February 2000.
The ClinicalTrials.gov registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trail registration information to be submitted The law also requires the submission of results for certain trials. This led to the development of the ClinicalTrials.gov results database, which contains summary information on study participants and study outcome, including adverse events. The results database was made available to the public in September 2008.
What studies are required to be registered?
Applicable Clinical Trials (ACTs)
ACTs are interventional studies of drugs, biologics, or devices that meet the criteria outlined in the ACT check list.
NIH Funded Clinical Trials
The National Institutes of Health (NIH) Policy on Dissemination of NIH-Funded Clinical Trial Information requires registration and results reporting, and applies to all clinical trials funded by NIH, regardless of whether they are subject to the FDAAA 801 and the Final Rule effective January 18, 2017.
Learn about Clinical Trials Reporting
International Committee of Medical Journal Editors (ICMJE)
The ICMJE requires and recommends that all medical journal editors require registration of clinical trials in a public trials registry before the time of first patient enrollment as a condition of consideration for publication.
Medicare Billing
Effective January 1, 2015, all Medicare qualifying trials, including some Phase 1 and device feasibility trials, are required to be registered into the ClinicalTrials.gov database. NCT numbers are required on clinical research related claims in order to receive payment. Patients should not be enrolled on a trial unless the NCT registration number is in place.
Additional Resources
For more information please review the ClinicalTrials.gov Homepage for valuable resources:
For the home page click on the “Learn more” tabs under “Researchers” or “Study Record Managers” for templates, definitions, and more.
For NIH specific guidance please visit NIH Clinical Trials Information, for detailed information regarding what qualifies as a clinical trial and which studies are required to be registered and report results.