FDA asks developers to publish trial results

The Food and Drug Administration said it has sent more than 2,200 reminder letters to drug companies, device makers, and researchers that appear to be missing legally required trial results on ClinicalTrials.gov. (fda.gov) The agency said its letters went out in late March 2026 after an internal review found that results were missing for nearly 30% of studies “highly likely” to be covered by federal reporting rules. (fda.gov) ClinicalTrials.gov is the federal database where sponsors register human studies and post summary findings, including basic safety and effectiveness data, so doctors, patients, and other researchers can see what a trial found. The reporting rules generally apply to many Food and Drug Administration-regulated drug, biologic, and device trials, though phase 1 drug trials and small feasibility device studies are typically excluded. (clinicaltrials.gov) Under the Food and Drug Administration Amendments Act of 2007 and the 2016 “Final Rule,” covered trials generally must submit results no later than one year after the study’s primary completion date, with some exceptions and delay provisions. (clinicaltrials.gov) (pmc.ncbi.nlm.nih.gov) The Food and Drug Administration said missing results can distort the evidence base because unsuccessful or negative studies are less likely to appear in journals, leaving the public record tilted toward positive findings. (fda.gov) That gap has persisted for years. A 2016 New England Journal of Medicine article by ClinicalTrials.gov officials said federal law had expanded mandatory reporting, but compliance and enforcement remained uneven even after Congress created civil penalties for nonreporting. (pmc.ncbi.nlm.nih.gov) The current push fits into a broader transparency campaign under Commissioner Marty Makary. In July 2025, the agency published more than 200 complete response letters for rejected drug and biologic applications, calling the move part of a “radical transparency” effort. (fda.gov) The New York Times reported that the new letters are framed as reminders, not formal enforcement actions, and that the agency is relying first on public pressure and direct outreach to improve compliance. (nytimes.com) Stat reported that Food and Drug Administration officials described the effort as risk-based and said they could consider regulatory action later if sponsors and investigators still do not submit required results. (statnews.com) What happens next is straightforward: companies and researchers that received letters can either post the missing summaries to ClinicalTrials.gov or explain why their studies were not legally required to report results. (fda.gov)