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Fraud in Clinical Trials

In: Principles and Practice of Clinical Trials

Author

Listed:
  • Stephen L. George

    (Duke University School of Medicine, Department of Biostatistics and Bioinformatics, Basic Science Division)

  • Marc Buyse

    (International Drug Development Institute (IDDI) Inc.
    University of Hasselt, CluePoints S.A., Louvain-la-Neuve, Belgium and I-BioStat
    Hasselt University, Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat))

  • Steven Piantadosi

    (Brigham and Women’s Hospital, Harvard Medical School, Department of Surgery, Division of Surgical Oncology)

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.

Suggested Citation

  • Stephen L. George & Marc Buyse & Steven Piantadosi, 2022. "Fraud in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 118, pages 2319-2337, Springer.
  • Handle: RePEc:spr:sprchp:978-3-319-52636-2_163
    DOI: 10.1007/978-3-319-52636-2_163
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