New investigation reveals FDA, NIH let clinical trial sponsors keep trial results secret

Despite a now 2-year-old law requiring clinical trial sponsors to disclose results, a new investigation from Science and former STAT reporter Charles Piller finds that many ignore the law — much as they have done in the past. Sponsors have up to a year after a trial’s completion to submit results, but the report found that of 216 trials that were due to log their results by the end of September 2019, only a third did so. The violators include regular NIH funding recipients including Boston Children’s Hospital and Baylor College of Medicine. At the same time, even though the NIH has previously said it would cut off funding for those who fail to report results as required by law, it has not done so. The FDA has also not excised its fine for violators — up to $12,103 for every day of noncompliance.