Lexology August 22, 2023
Baker & Hostetler LLP

Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials it sponsored, according to a 2022 Office of Inspector General report. Lack of transparency in clinical trials not only harms the integrity of the scientific process but also can result in civil or criminal penalties and impact grant funding.

Universities and academic medical centers, which often conduct research as sponsor-investigators, are among the worst offenders in failure to report data from clinical trials, most of which are federally funded. This failure to report poses a great risk of conflicts of interest and can contribute to undermining public trust...

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Topics: Clinical Trials, FDA, Govt Agencies, Health System / Hospital, OIG, Provider, Survey / Study, Trends
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