The US Food and Drug Administration (FDA) 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.
As stated in a press release from the US FDA, 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”. This gap can also create a “distorted perception” of the safety and efficacy of medical products, the US FDA notes.
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. However, phase-one and device-feasibility studies are excluded.
“Far too often, companies are suppressing unfavourable clinical trial results, and keeping them secret from patients and the scientific community,” said US FDA commissioner Marty Makary. “Those sponsoring clinical trials have an ethical obligation to make results public, regardless of the data’s influence on the company’s share price. Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers. If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”
Certain clinical trial sponsors and researchers are required to submit information on trial results to ClinicalTrials.gov one year after trial completion, as per the US FDA. On 30 March this year, 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. These messages sought “voluntary compliance with requirements”, according to the US FDA.
In its recent press release, the regulator goes on to note that it may also send pre-notices and notices of non-compliance as part of risk-based compliance efforts related to ClinicalTrials.gov. The messages issued on 30 March represent an “extra step” the US FDA 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.
“I fully support this new initiative to increase the prompt publication—as required by law—of results information from interventional studies of the medical products we regulate,” commented Tracy Beth Hoeg, acting director of the US FDA’s Center for Drug Evaluation and Research (CDER). “We hope that the thousands of messages sent to sponsors and investigators reminding them to publicly report their findings will improve patient safety, and keep researchers and the public better informed of benefits and risks of new and investigational products.”
