Fraud in Clinical Trials

Stephen L. George (), Marc Buyse () and Steven Piantadosi ()
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Stephen L. George: Duke University School of Medicine, Department of Biostatistics and Bioinformatics, Basic Science Division
Marc Buyse: International Drug Development Institute (IDDI) Inc.
Steven Piantadosi: Brigham and Women’s Hospital, Harvard Medical School, Department of Surgery, Division of Surgical Oncology

Chapter 118 in Principles and Practice of Clinical Trials, 2022, pp 2319-2337 from Springer

Abstract: Abstract Several high-profile cases of fabrication or falsification of data have occurred in clinical trials in recent years. The number of such reported cases is quite low, given the large number of clinical trials conducted worldwide. Although this suggests that the prevalence of fraud is very low, reliable evidence on prevalence is lacking. Regardless of the true prevalence, fraud is damaging to the public trust in the clinical trial process and can put patients at risk. This chapter summarizes some prominent examples of detected fraud in clinical trials, the existing evidence on prevalence, contributing predisposing factors and statistical techniques for detection of fraud.

Keywords: Fraud; Fabrication; Falsification; Prevalence of fraud; Case studies; Detection of fraud; Central statistical monitoring (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_163

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