Clinical trial sponsors have to disclose decade’s worth of unreleased data, federal judge rules
A decade’s worth of unreleased trial data may soon see the light of day.
A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.
The FDA had been interpreting a ‘final rule’ added to 2007 law, known as the Food and Drug Administration Amendments Act, to mean that sponsors only had to report results for trials that were completed after the law rule was promulgated in 2017. Plaintiffs said it was retroactive.
“The court has set aside that erroneous interpretation of the law and has said that the statute means what it has always said,” Christopher Morten, the lawyer for the plaintiffs, told Endpoints News. “So our hope here is that trial sponsors are going to start, finally, after years of noncompliance, reporting some of that missing data to the patients.”
The FDA and the NIH did not put out statements following the ruling and did not immediately respond to requests for comment.
FDAAA was the law that required sponsors to register most trials on clinicaltrials.gov, and in 2018 the change went into effect requiring that companies post results within a year of the trial’s completion. The government interpreted it to mean only the results of trials completed after the law went into effect.
The FDA and NIH’s execution of that rule, though, has been the subject of major scrutiny in the last few months. Investigations in The Lancet and in Science published in January found that trial sponsors have widely ignored the reporting requirements since 2018. The Lancet study, by Ben Goldacre, found only 41% of over 4,700 trials reported on time. Analyzing a similar dataset, Science’s Charles Piller found 45% noncompliance and isolated a group of 30 “habitual offenders” who collectively failed to report the results 67% of the time.
Advocates for greater transparency say this kind of obfuscation hurts the field by giving doctors and researchers only a partial glimpse at the overall results. It can even be dangerous, Morten argued. He cited Vioxx, the painkiller Merck pulled off the market in 2004 after studies showed an increased risk of stroke. Had Merck disclosed pre-approval trial results sooner, Morten said, the risk could have been caught sooner.
The case was brought by former associate FDA commissioner Peter Lurie and NYU journalist Charles Seife, who argued a misinterpretation of the rule has impeded their work more broadly. The ruling takes the reporting requirements previously applied only to trials completed since 2018 and applies them to those completed since 2007.
“That’s hurt patients who lack the opportunity to learn about the drugs they take, it’s hurt doctors that lack information on the drugs they prescribe, and it’s hurt researchers like Charles and Peter,” Morten said.
It’s not clear, though, how the ruling will be enforced. The plaintiffs were overruled on a separate issue, in which they argued the FDA and NIH were not abiding by a statute requiring them to give public notice of noncompliance to companies not abiding by the FDAAA rules.
The government could yet appeal the ruling but it’s not yet clear if they will.