Missing clinical trial data must be made public, federal judge says

Drug companies, device manufacturers, and universities must turn over missing data from hundreds of clinical trials conducted in the United States from 2007–17, a federal judge ruled this week. The ruling from the Southern District of New York says government agencies including the National Institutes of Health, the U.S. Department of Health and Human Services, and the Food and Drug Administration (FDA) for years misinterpreted a law requiring them to collect and post data to ClinicalTrials.gov, a publicly accessible government database.

If it is upheld, the ruling would make it harder for drug companies to keep unfavorable results from the public, and it could offer vital information for patients and doctors, STAT reports. Still unclear is how quickly the agencies might move to fill in the 10-year gap in compliance—and what the consequences would be for clinical trial sponsors that don’t comply.