NIH Considers Increased Enforcement as Two-Thirds of Trials Miss Reporting Deadlines
The National Institutes of Health (NIH) has found that only one-third of its grant-funded trials filed results with ClinicalTrials.gov on time, highlighting a continuing compliance problem NIH intends to address with greater communication and possible enforcement action.
Of the 530 NIH-funded trials required to submit their findings in FY 2020, 2021 or 2022, nearly all (96 percent) complied, but just 37 percent of these trials submitted their results on time, according to an analysis conducted by the agency.
Since 2016, NIH grant-funded trials have been required to submit their results within 365 days of completing the trial. NIH recognizes it needs to make more concerted efforts to address the issue, indicated NIH Deputy Director for Extramural Research Mike Lauer.
“[The 2016] policy has already proven to be effective as recent analyses have demonstrated increased clinical trial results information reporting. However, we acknowledge that we still have work to do to increase timely compliance,” Lauer wrote in a recent NIH blog post. “Moving forward, you will see increased communication from us and, if needed, enforcement actions to get us to where we need to be.”
NIH is asking researchers to be responsive to letters about potentially noncompliant trials and submit trial results as soon as possible, ideally well in advance of the 365-day deadline.
For institutional leaders, NIH asks that they stress the importance of timely reporting to their faculty and develop internal controls to enable efficient, easy reporting of results.
“Clearly, we still need to improve and we are committed to taking this challenge head on,” Lauer wrote. “With your help, we can together assure a transparent and accountable clinical trials system.”
Read the report here: https://bit.ly/419ijph.
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