The United States Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirement to submit certain clinical trial results to ClinicalTrials.gov.

Companies and researchers often fail to disclose negative results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes —over-representing successes and under-representing failures. This gap can also create a distorted perception of the safety and efficacy of medical products.

According to an internal analysis, 29.6 per cent 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 US nexus and an FDA-regulated product, which are past the reporting deadline; it excludes Phase 1 and device feasibility studies.

“Far too often, companies are suppressing unfavourable 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.

 “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 to ClinicalTrials.gov one year after trial completion. On March 30, 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 did not appear to have submitted required results to ClinicalTrials.gov, or may have not completed the National Library of Medicine’s quality control review process. The messages seek voluntary compliance with requirements.

(Source: USFDA)

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Published on April 20, 2026