After an internal review found that 3 out of 10 clinical trial results are unreported, the FDA reached out to thousands of medical product companies and researchers, reminding them to submit their findings.
The move is intended to improve patient safety and ensure clinicians, researchers and the public are better informed about the benefits and risks of new products, according to the agency's press release.
Clinical trial sponsors and researchers often fail to report unfavorable trial results, creating gaps in the public record, the FDA said. The practice also fuels publication bias that distorts the "true landscape of drug development outcomes -- overrepresenting successes and underrepresenting failures." This imbalance can lead to skewed perceptions of a product's safety and efficacy, the agency said.
"Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community. Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data's influence on the company's share price," FDA Commissioner Marty Makary, M.D., M.P.H., said. "Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers."
Makary added that physicians deciding which medications to prescribe also deserve access to the best available clinical data.
Clinical trial sponsors are legally required to submit results to ClinicalTrials.gov within a year of a trial's primary completion date. This requirement applies to interventional trials of FDA-regulated products with a connection to the U.S. that have passed their reporting deadline. Phase 1 and device feasibility studies are excluded.
An internal analysis found that 29.6% of studies that are likely subject to mandatory reporting requirements have not yet posted results on the government's clinical trials website.
Just over two weeks ago, the FDA urged voluntary compliance of more than 2,200 sponsors and investigators responsible for more than 3,000 clinical trials that have not yet submitted the required information or completed the National Library of Medicine's quality control review process. Some of the trials were publicly funded, the FDA noted.
The reminders, sent on March 30, represent an additional step the agency is taking to reel in missing trial results, the FDA said. The agency says it is giving responsible parties an opportunity to comply with federal law before pursuing further regulatory action.
For those that remain noncompliant, the FDA could ratchet up pressure by issuing warning letters or civil monetary penalties of up to $10,000 per day.
In 2021, the FDA issued its first-ever Notice of Noncompliance to Acceleron Pharma for failing to provide data from a completed phase 2 trial of an experimental cancer drug the company scrapped. The results had been published behind a paywall in 2019 but were not added to the government's website until the FDA threatened financial penalties
The agency issued a similar warning to Ocugen in 2022, over the company's failure to submit results from a phase 3 trial of its dry eye drug, which had not met its primary endpoints. Ocugen submitted the required data within the 30-day window it was given.
The FDA has yet to collect a cash penalty from any sponsor for failing to submit trial data.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
