The NIH says it has brought more than 200 tardy investigators into compliance since July 2022.
As recently as August 2022, the U.S. Department of Health and Human Services’s Office of Inspector GeneralNIH-funded clinical trials due to report their results in 2019 and 2020 had done so in a timely manner—and that 25 had not submitted them at all.
“Clearly, we still need to improve, and we are committed to taking this challenge head on,” Lauer wrote on the blog. “Moving forward, you will see increased communication from us and, if needed, enforcement actions to get us to where we need to be.” Deborah Zarin, who directed ClinicalTrials.gov from 2005 to 2018, argues that trial registration and results reporting is as important as getting a research volunteer’s informed consent to participate in a study. “What if I told you that 18% of trials had not obtained informed consent? You’d probably be appalled,” says Zarin, who is now at Harvard University and Brigham and Women’s Hospital.
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