The U.S. Food and Drug Administration (FDA) has sent messages to more than 2,200 medical product companies and researchers reminding them of requirements to submit clinical trial results to ClinicalTrials.gov.
The agency sent the messages on March 30 in connection with more than 3,000 registered clinical trials -- including some that were publicly funded -- that do not appear to have submitted required results information to the site, or that may not have completed the National Library of Medicine's quality control review process, the FDA said. According to an internal FDA analysis, 29.6% of studies highly likely to fall under mandatory reporting requirements have no results information submitted to ClinicalTrials.gov.
Certain clinical trial sponsors and researchers are required to submit results to ClinicalTrials.gov one year after trial completion. Studies subject to mandatory reporting include interventional studies with a U.S. nexus and an FDA-regulated product that are past the deadline to report, excluding phase I and device feasibility studies.
The messages seek voluntary compliance, although the FDA said it may also send pre-notices of noncompliance and notices of noncompliance as part of risk-based compliance efforts.
