FDA and NIH let clinical trial sponsors keep results secret, investigation shows

This story was originally published by Science. It is a follow-up to STAT articles in 2015 and 2018 on the failure of many clinical trial sponsors to report results to ClinicalTrials.gov.

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health and the Food and Drug Administration tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results.

The rule took full effect two years ago, on Jan. 18, 2018, giving trial sponsors ample time to