FDA Calls for Disclosure of Clinical Trial Results

The U.S. Food and Drug Administration (FDA) has reminded over 2,200 companies and researchers involved in the development of medical products of their obligation to submit information on the results of clinical trials. Companies and researchers frequently fail to report negative trial results, leaving significant gaps in the public record. This publication bias distorts the true picture of drug development, overrepresenting successes while underrepresenting failures. It can also create a distorted perception of the safety and efficacy of medical products.

Background

Certain clinical trial sponsors and researchers are required to submit clinical trial results information one year after trial completion. According to an internal analysis, 29.6% of studies that are highly likely to fall under the mandatory reporting requirements have no results information submitted. On 30 March 2026, the agency sent messages to a wide range of companies and researchers associated with more than 3,000 registered clinical trials (including some that were publicly funded) who do not appear to have submitted the required information on trial results to ClinicalTrials.gov, or who may not have completed the National Library of Medicine's quality control review process. These messages represent an additional step taken by the agency to provide the relevant responsible parties with an opportunity to comply with federal law before the agency considers taking further regulatory action, such as issuing Pre-Notices or Notices of Noncompliance).  

More information is available in the FDA News Release.