FDA may fine clinical trial sponsors that don’t report dataBMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3322 (Published 24 August 2020) Cite this as: BMJ 2020;370:m3322
- Janice Hopkins Tanne
- New York
The US Food and Drug Administration has said it will penalise sponsors of clinical trials that do not report data to the ClinicalTrials.gov database, but it has not indicated whether it will go after all offenders.
The move came after the US Department of Health and Human Services, the FDA, and the National Institutes of Health were sued for failure to require reporting of clinical trial results and to make the results public.1 They lost the case earlier this year, after a federal court ruled that clinical trial sponsors …