The FDA has released final guidelines for penalizing companies and universities that fail to report clinical trial results.
According to the guidance, clinical trial sponsors that don't provide required information to ClinicalTrials.gov may face a $10,000 fine for each infraction.
The move comes after transparency advocates have pushed the FDA to encourage greater transparency about clinical trials. Researchers have argued that without access to specific data, trial results can't be easily replicated, which hinders the understanding of how medications might work and can lead to adverse treatment decisions and higher healthcare costs, STAT reported.
A study published in The New England Journal of Medicine in 2019 found slow progress in reporting the results of human studies among drugmakers and academic researchers over the last decade.
A separate study published in The BMJ last year found that most large drugmakers were insufficiently sharing study data after receiving approval for new drugs.
There is no policy for reporting trial results immediately, but a federal law requires clinical trial sponsors to post results to ClinicalTrials.gov a year after a study is completed, STAT reported. The reporting time can be expended to three years under some circumstances.
Some transparency advocates argue the new guidelines imposing a potential $10,000 fine are still too lax, according to STAT.
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