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NIH-Funded Clinical Trials Reported to ClinicalTrials.gov

The National Institutes of Health (NIH) provides funds to awardees to conduct clinical trials involving human subjects. These trials are intended to evaluate the effects of drugs or medical devices regulated by the FDA, as well as other interventions that are not regulated by the FDA. 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 for humans when used as intended. Having information about the results of clinical trials fosters improved patient safety by giving doctors, researchers, and the public at large access to information that may inform medical decisions, help focus on areas in need of study, and maximize the public's investment—and trust—in research. Federal law, regulations, and NIH award terms and conditions generally require NIH awardees to submit the results of certain clinical trials to NIH within 1 year after the earlier of the estimated or the completion date of the applicable clinical trial. NIH has extended this requirement to all clinical trials that receive NIH funding. NIH is required to post the results of these trials on Clinical Trials.gov within 30 days of receiving them. We will conduct an audit at NIH to determine whether NIH ensured that awardees of NIH-funded clinical trials complied with Federal reporting requirements.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
September 2020 National Institutes of Health NIH-Funded Clinical Trials Reported to ClinicalTrials.gov Office of Audit Services W-00-20-51020 2022