FDA Urges Over 2,200 Clinical Trial Sponsors and Researchers to Report Results to ClinicalTrials.gov
In April 2026, the FDA contacted more than 2,200 sponsors and researchers associated with over 3,000 clinical trials on March 30, 2026, reminding them to submit results to ClinicalTrials.gov.
Certain sponsors must report results within one year of trial completion, excluding Phase 1 and device feasibility studies.
An FDA analysis shows 29.6% to 30% of applicable studies lack reported results, causing publication bias that overrepresents successes and underrepresents failures.
FDA Commissioner Marty Makary emphasized the ethical obligation to disclose results regardless of outcome to ensure transparency for clinicians and patients.
This outreach seeks voluntary compliance before potential enforcement like notices of noncompliance and fines over $10,000 per day.