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.
A 2015 STAT investigation found that research universities vary widely on how or whether they post clinical trial results. Further reporting by Science found that FDA has never imposed a fine on a clinical trial’s sponsor for not complying with federal regulations. The plaintiffs in the lawsuit are Peter Lurie, a former associate FDA commissioner, and Charles Seife, a New York University professor and a writer for multiple outlets, including Science.
Source: Science Mag