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.
“NIH did not ensure that all NIH-funded Intramural and Extramural clinical trials complied with Federal reporting requirements for responsible parties to submit the results of clinical trials to ClinicalTrials.gov,” the IG found.
"*" indicates required fields
“The noncompliance with Federal reporting requirements occurred because NIH did not have adequate procedures for ensuring that responsible parties submitted the results of clinical trials, took limited enforcement action when there was noncompliance, and continued to fund new research of responsible parties that had not submitted the results of their completed clinical trials,” the IG said. “For the 47 NIH-funded clinical trials in which the responsible party submitted their results (35 submitted on time and 12 submitted late) NIH complied with the Federal reporting requirements to post the results to ClinicalTrials.gov.”
The IG’s striking report follows upon the Director of the Centers for Disease Control and Prevention admitting that the agency failed to achieve its results during the Covid-19 pandemic and calling for sweeping reorganization.
“To be frank, we are responsible for some pretty dramatic, pretty public mistakes, from testing to data to communications,” she said in a video address given to the CDC’s roughly 11,000 employees.
“Her admission of the agency’s failings came after she received the findings of an examination she ordered in April amid scathing criticism of the C.D.C.’s performance,” WSJ reported on the confession. “The report itself was not released; an agency official said it was not yet finished but would be made public soon.”
If the Inspector General’s report is any indication, a full report isn’t likely to come out in public anytime soon, if it comes out at all.