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Fraud in Clinical Trials

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Principles and Practice of Clinical Trials

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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.

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Author information

Authors and Affiliations

  1. Department of Biostatistics and Bioinformatics, Basic Science Division, Duke University School of Medicine, Durham, NC, USA

    Stephen L. George

  2. International Drug Development Institute (IDDI) Inc., San Francisco, CA, USA

    Marc Buyse

  3. Department of Surgery, Division of Surgical Oncology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Steven Piantadosi

  4. CluePoints S.A., Louvain-la-Neuve, Belgium and I-BioStat, University of Hasselt, Louvain-la-Neuve, Belgium

    Marc Buyse

  5. Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), Hasselt University, Hasselt, Belgium

    Marc Buyse

Authors
  1. Stephen L. George
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  2. Marc Buyse
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  3. Steven Piantadosi
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Corresponding author

Correspondence to Stephen L. George .

Editor information

Editors and Affiliations

  1. Department of Surgery, Division of Surgical Oncology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Steven Piantadosi

  2. Department of Epidemiology, School of Public Health, Johns Hopkins University, Baltimore, MD, USA

    Curtis L. Meinert

Section Editor information

  1. Rockville, Maryland, USA

    Lawrence Friedman MD

  2. Director, Office of Biostatistics Research, National Heart Lung and Blood Institute (NHLBI), Bethesda, MD, USA

    Nancy L Geller Ph.D

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George, S.L., Buyse, M., Piantadosi, S. (2022). Fraud in Clinical Trials. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52636-2_163

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