By Zachary Stieber
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.
While the NIH followed the law in terms of posting the results, it did little when parties submitted the results later or never submitted them, the watchdog review found.
When NIH scientists failed to follow the law, the agency’s Office of Intramural Research only sent notices of noncompliance, but took no other action. Meanwhile, the NIH’s Office of Extramural Research, which funds outside parties, sometimes did not follow its procedures in all cases, in part because of concerns that taking an enforcement action would result in halting funding to an entire institution, an official with the office told investigators.
Instead, NIH officials prefer to work with staffers at the institution “to ensure that they input their results,” the report said, citing the official.
Even the parties that did not submit trial results kept receiving funding, the review found.
Trial results not being posted, or being posted late, prevents health care providers, patients, and fellow researchers from seeing how a certain drug, vaccine, or product performed.
The watchdog recommended NIH improve its procedures to make sure trial results are submitted in a timely manner, enforce the rules against parties that submit results late or not at all, and help parties who find submitting to the government website challenging.
The NIH did not respond to a request for comment. In a written response to the watchdog, the agency concurred with the recommendations and said it has taken actions or plans to take actions to address the issues. That includes adding consequences to parties funded by the Office of Intramural Research that submit results late or not at all.