NIH Inspector General Finds More Than Half of Clinical Trials During Covid ‘Did Not Comply’ with Federal Requirements 

  • The National Institutes of Health’s Office of the Inspector General has found that more than half the clinical trials funded in response to the Covid-19 pandemic did not comply with federal guidelines.
  • The OIG report, which was released earlier this week, sheds light on the lax approach that the nation’s premier health institutes took to ensure that the clinical trials met the highest standards for transparency and timely reporting.
  • “We reviewed all 72 NIH-funded Intramural and Extramural clinical trials for which Federal law and NIH policy required the results to be reported in calendar year 2019 or 2020,” the NIH’s Inspector General stated. “To determine whether responsible parties complied with reporting requirements, we compared the date the results should have been submitted with the date they were submitted. We also determined whether NIH posted the clinical trial results submitted by the responsible parties to ClinicalTrials.gov within 30 days of the submission date.”
  • The NIH’s IG found that more than half the clinical trials did not meet the requisite federal reporting guidelines, either by failing to meet the deadline or by not reporting the results at all. The Table summarizes the number of clinical trials requiring results to be submitted in 2019 or 2020 that were submitted on time, late, or not submitted at all.