FDA reminds sponsors to disclose trial results

The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers to submit required clinical trial results information to ClinicalTrials.gov.

According to FDA, 29.6% of studies highly likely to fall under mandatory reporting requirements have no results information submitted to the federal database.

Mandatory reporting applies to interventional studies with a U.S. nexus and an FDA-regulated product that are past the deadline to report. Phase 1 studies and device feasibility studies are excluded, the agency said.

On March 30, FDA sent messages to companies and researchers associated with more than 3,000 registered clinical trials. Some of those trials were publicly funded.

Agency messages targeted trials that do not appear to have submitted required results information or may not have completed the National Library of Medicine’s quality-control review process. FDA said the messages seek voluntary compliance.

Clinical trial sponsors and researchers are generally required to submit results information to ClinicalTrials.gov 1 year after trial completion, FDA said. ClinicalTrials.gov lists the standard results submission deadline as within 1 year of the completion date.

FDA said it may also send pre-notices of noncompliance and notices of noncompliance as part of risk-based compliance efforts related to ClinicalTrials.gov.