The U.S. Food and Drug Administration (FDA) has issued a reminder to over 2,200 medical product companies and researchers about the necessity of submitting specific clinical trial results to ClinicalTrials.gov.
Many companies and researchers fail to report negative results, leading to significant gaps in the public record and a publication bias that skews the understanding of drug development outcomes. This often results in an overrepresentation of successes while minimizing failures, which can distort perceptions regarding the safety and efficacy of medical products.
An internal analysis revealed that 29.6 percent of studies that are likely subject to mandatory reporting have not submitted results to ClinicalTrials.gov. Mandatory reporting applies to interventional studies associated with U.S. FDA-regulated products and completed past the reporting deadline, excluding 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,” stated FDA Commissioner Marty Makary.
He further emphasized the importance of reporting, noting, “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.”
Clinical trial sponsors and researchers are required to submit results to ClinicalTrials.gov within one year following trial completion. On March 30, the FDA reached out to more than 2,200 companies and researchers—linked to over 3,000 registered clinical trials, including some funded by public sources—that had not submitted the required results or failed to complete the National Library of Medicine’s quality control review. The messages aim to encourage voluntary compliance with these requirements.
(Source: USFDA)
