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Clinical Trials

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Clinical Trials

There is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov is a service of the U.S. National Institute of Health and provides information about a trial's purpose, who may participate, locations, and phone numbers. You can use this tool to identify if your study meets the NIH definition of a clinical trial. 

New Rules Pertaining to ClinicalTrials.gov

In September 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies and expands the regulatory requirements for submitting registration and summary results information of clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. The final rule is intended to make it clear to sponsors, investigators, and the public which trials must be submitted, when they must be submitted, and whether compliance has been achieved. For example, the final rule clarifies the definition of an Applicable Clinical Trial and provides structured criteria for determining which studies meet the definition. The final rule also expands the FDAAA 801 requirements by requiring the submission of results information for trials of unapproved products. The regulation was put into effect on January 18, 2017 and responsible parties are expected to be in compliance as of April 19, 2017.

With the changes to the federal regulations governing human subjects research, implemented on January 21, 2019, clinical trials also need to post one informed consent form used to enroll subjects after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject. The NIH Clinical Trials website is the location currently identified for this posting. 

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