FDA renews criticism of trial sponsors over transparency
The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative – saying around a third of them are going unreported.
In a statement, the US regulator has said it has "reminded" around 2,200 product manufacturers and researchers by letter of the reporting requirements for studies registered with the clinicaltrials.gov database.
It added that its internal analyses suggest 29.6% of clinical trials that are "highly likely to fall under mandatory reporting requirements" still have no results uploaded to the registry.
The data transparency issue became a flashpoint for the pharma industry a few years ago, with the FDA eventually issuing warning notices to various companies and researchers that had failed to submit results as required by federal law.
Under current US regulations, phase 2 to 4 trials of FDA-regulated drugs, biologics, and devices – including unapproved products and international studies with a US component – should be uploaded to the registry within 12 months of the study's primary completion date.
"Far too often, companies are suppressing unfavourable clinical trial results and keeping them secret from patients and the scientific community," commented 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," he added. "Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers."
According to the agency, the failure to report results is leading to significant gaps in the public record and a publication bias that is obscuring the true landscape of drug development outcomes and creating a distorted perception of the safety and efficacy of medical products.
For now, the FDA is simply asking trial sponsors to make sure they meet the required reporting standards, but it has also threatened to up the ante for those that fail to do so by issuing notices of non-compliance, which can lead to fines.
That's something that has happened rarely, with only eight such notices listed by the FDA on its website, with Acceleron, Accuitis, Ocugen, and Light Sciences Oncology among the recipients, but there is no record of any 'civil money penalties' being applied to date.
There are also over 230 'pre-notices of non-compliance' listed by the FDA, which are letters sent to sponsors suspected of failing to submit required clinical trial information.
According to a 2020 paper published in The Lancet by researchers at Oxford University in the UK, analysing clinicaltrials.gov registrations over an 18-month period between 2018 and 2019, only 40% of studies had results submitted within the one-year deadline. Two-thirds of them had results uploaded, but outside the required timeframe.
The authors concluded at the time that compliance with regulations was "poor, and not improving," with unreported results distorting the evidence base for clinical practice, breaching researchers' ethical obligations to patients, and wasting research resources.
