FDA warns more than 2,200 sponsors and researchers on missing ClinicalTrials.gov results
The US Food and Drug Administration sent messages on 30 March to more than 2,200 companies and researchers tied to over 3,000 clinical trials over missing ClinicalTrials.gov results. The agency said 29.6% of studies highly likely to be subject to mandatory reporting had no results information submitted.
The US Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of requirements for them to submit certain information on clinical trial results to ClinicalTrials.gov. On 30 March, the regulator sent messages to more than 2,200 companies and researchers associated with more than 3,000 registered clinical trials, including some that were publicly funded, that do not appear to have submitted requisite results information to the ClinicalTrials.gov website, or that may not have completed the US National Library of Medicine’s quality control review process.
According to an internal analysis conducted by the regulator, 29.6% of studies that are “highly likely” to fall under mandatory reporting requirements have no results information submitted to ClinicalTrials.gov. Studies subject to the mandatory reporting requirements include interventional studies with a US nexus and an FDA-regulated product that are past the deadline to report. Phase-one and device-feasibility studies are excluded.
Certain clinical trial sponsors and researchers are required to submit information on trial results to ClinicalTrials.gov one year after trial completion. The messages sent on 30 March sought “voluntary compliance with requirements” and represent an “extra step” the regulator is taking to provide the relevant responsible parties with the opportunity to comply with federal law before the agency considers whether to take further regulatory action.
The regulator said companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that “obscures the true landscape of drug development outcomes” by “overrepresenting successes and underrepresenting failures”. The regulator said this gap can also create a “distorted perception” of the safety and efficacy of medical products.
The regulator said it may also send pre-notices and notices of non-compliance as part of risk-based compliance efforts related to ClinicalTrials.gov. The acting director of the Center for Drug Evaluation and Research said the initiative is intended to increase the prompt publication, as required by law, of results information from interventional studies of the medical products the agency regulates.