Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials

JAMA
May 19, 2020, Vol 323, No. 19, Pages 1873-1982
https://jamanetwork.com/journals/jama/currentissue

 

Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials
Rafael Dal-Ré, MD, PhD, MPH; Aaron S. Kesselheim, MD, JD, MPH; Florence T. Bourgeois, MD, MPH
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JAMA. 2020;323(19):1903-1904. doi:10.1001/jama.2020.1631
This Viewpoint reviews notable examples of clinical trial misconduct identified by routine US Food and Drug Administration (FDA) clinical trial site inspections and argues that making inspection reports publicly available on the agency’s and trial registry websites is important to maintaining the integrity of clinical research.