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.
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