Out of 72 NIH-funded studies in 2019 and 2020—half of which were conducted by NIH scientists—results from only 35 were submitted to the agency on time, according to a 14-page report from the Department of Health and Human Services Office of Inspector General.
The results of 12 were submitted late, while results from the different 25 were never submitted.
Federal law needs that the responsible party—the sponsor or, if designated, the principal investigator—submit 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 different products. With few exceptions, once the NIH gets the results, it must post them on ClinicalTrials.gov within 30 days.
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The watchdog review found that while the NIH followed the law in posting results, it did little when parties were late in turning in results or failed to submit them.
When NIH scientists failed to follow the law, the agency’s Office of Intramural Research only sent notices of noncompliance yet took no other action. In the meantime, the NIH’s Office of Extramural Research, which funds outside parties, sometimes didn’t follow its procedures in all cases, in part because of concerns that taking an enforcement action would end in a halt in funding to an entire institution, an official with the office told investigators.
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Instead, NIH officials prefer to work with staffers at the institution “to ensure that they input their results,” the report announced, mentioning the official.
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The review found that even the parties that didn’t submit trial results kept receiving funding.
Trial results not being posted or posted late prevents health care providers, patients, and fellow researchers from seeing how a certain drug, vaccine, or product performed.
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The watchdog recommended NIH improve its procedures to ensure trial results are submitted promptly, enforce the rules against parties that submit results late or not at all, and help parties who find submitting to the government website challenging.
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The NIH didn’t reply to a request for comment. In a written response to the watchdog, the agency concurred with the recommendations and announced it has taken actions or intends 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.
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