FDA urges publication of missing trials

The Food and Drug Administration said on April 13 that it had contacted more than 2,200 companies and researchers about missing clinical trial results that should be public on ClinicalTrials.gov. (fda.gov) The agency said the March 30 messages covered more than 3,000 registered trials and were sent to drug makers, device companies and researchers, including some tied to publicly funded studies. (fda.gov) The Food and Drug Administration said 29.6% of studies “highly likely” to fall under mandatory reporting rules had no results posted, even though many sponsors are supposed to submit summary findings within one year of trial completion. (fda.gov) ClinicalTrials.gov is the federal database that lists studies and their outcomes, and the reporting rules come from the Food and Drug Administration Amendments Act of 2007 and a final rule that took effect in 2017. (clinicaltrials.gov 1) (clinicaltrials.gov 2) Those rules apply to certain “applicable clinical trials,” generally interventional studies with a United States nexus and a Food and Drug Administration-regulated product; phase 1 drug trials and small device feasibility studies are excluded. (fda.gov) (ecfr.gov) The Food and Drug Administration said missing results can skew the record because unsuccessful or unfavorable findings disappear, leaving doctors, patients and researchers with an incomplete picture of a product’s safety and effectiveness. (fda.gov) Commissioner Marty Makary said sponsors have an “ethical obligation” to make trial results public regardless of whether the data help a company, and he tied the effort to prescribing decisions made by physicians. (fda.gov 1) (fda.gov 2) For now, the agency framed the outreach as a chance to comply voluntarily before stronger steps, saying it can send pre-notices of noncompliance and formal notices of noncompliance as part of a risk-based enforcement process. (fda.gov 1) (fda.gov 2) Federal guidance also allows civil money penalties for some ClinicalTrials.gov violations, and the Food and Drug Administration posts notices of noncompliance on its website. (hhs.gov) (fda.gov) The immediate next step is simple: the agency wants thousands of overdue trial records filled in, so the public database shows failed studies alongside successful ones. (fda.gov)