National Institutes of Health Failed to Make Sure Clinical Trial Results Were Reported: Watchdog
The National Institutes of Health (NIH) violated policy that requires the agency to make sure results from trials it funds are published, and did not impose consequences on parties that broke federal law governing the reporting, a watchdog has found.
Out of 72 NIH-funded studies in 2019 and 2020, half of which were conducted by NIH scientists, results from just 35 were submitted to the agency on time, according to a 14-page report (pdf) from the Department of Health and Human Services Office of Inspector General.
The results of 12 were submitted late. Results from another 25 were never submitted.
Federal law requires the responsible party—the sponsor or, if designated, the principal investigator—to submit the trial results within one year of whichever comes earlier, the estimated or actual completion date. The law applies to trials on most drugs, vaccines, and other products. With few exceptions, once the NIH receives the results, it must post them on ClinicalTrials.gov within 30 days….