FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results

The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov. Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures. This gap can also create a distorted perception of the safety and efficacy of medical products.

According to an internal analysis, 29.6% of studies that are highly likely to fall under mandatory reporting requirements have no results information submitted to ClinicalTrials.gov. Studies subject to the mandatory reporting requirements include interventional studies with a U.S. nexus and an FDA-regulated product that are past the deadline to report; it excludes Phase 1 and device feasibility studies.

“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community. Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data’s influence on the company’s share price,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers. If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”

Certain clinical trial sponsors and researchers are required to submit clinical trial results information to ClinicalTrials.gov one year after trial completion. On March 30, 2026, the agency sent messages to more than 2,200 companies and researchers (associated with more than 3,000 registered clinical trials, including some that were publicly funded) that do not appear to have submitted required results information to ClinicalTrials.gov, or that may have not completed the National Library of Medicine’s quality control review process. The messages seek voluntary compliance with requirements.

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