The US Food and Drug Administration (FDA) has reminded more than 2,200 sponsors and researchers to publicly publish their clinical trial data.
Certain clinical trial sponsors and researchers are required to submit clinical trial results information to ClinicalTrials.gov one year after trial completion, regardless of whether the data is positive or negative.
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On 30 March 2026, the agency sent messages to more than 2,200 companies and researchers, associated with more than 3,000 registered clinical trials, that do not appear to have submitted required results information to ClinicalTrials.gov, or that may not have completed the National Library of Medicine’s quality control review process.
These requests represent an extra step the agency is taking to provide the responsible parties with the opportunity to comply with federal law before the agency considers whether to take action. Under the FDA Amendments Act of 2007 (FDAAA 801), most clinical trials must report summary results within one year of the primary completion date. If companies do not comply, the agency may move to issue “Pre-Notices” or “Notices of Noncompliance”, which could lead to substantial fines of over $10,000 per day for continued failure to report.
The agency said that negative data is often not disclosed, 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.
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. This includes interventional studies with a US nexus and FDA-regulated products that are past the deadline to report, but excludes Phase I and device feasibility studies.
FDA commissioner Marty Makary said: “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. 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.”
The European Medicines Agency (EMA) has taken a similar transparency stance with clinical trials. In October 2023, the EMA removed the deferral mechanism, which allowed sponsors to delay certain data and document publication for up to seven years after the end of their trial.
