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. 2015;5(2):161-173.
doi: 10.4155/cli.14.116.

Data fraud in clinical trials

Stephen L George  1 , Marc Buyse  2
Affiliations

Data fraud in clinical trials

Stephen L George et al. Clin Investig (Lond). 2015.

Abstract

Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality.

Keywords: central statistical monitoring; data fabrication and falsification; data fraud; data quality.

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Figures

Figure 1
Figure 1. Bubble plot showing the data inconsistency score as a function of the center size in a randomized clinical trial
The data from the centers above the horizontal line (labeled V, W, X, Y and Z) differ statistically form the data in all other centers. Fraud was confirmed to have occurred in center X (more details on the example can be found in [76]). FDR: False discovery rate; N: Number of patients per center.
Figure 2
Figure 2. Distribution of mean body temperatures (in °C) for centers in country A and for all other centers in a randomized clinical trial
The data from 10 of the 12 centers in country A differ statistically form the data in all other centers. The difference was found to be due to a single lot of miscalibrated thermometers. Adapted with permission form [81] © John Wiley and Sons (2014).
See this image and copyright information in PMC

References

    1. Institute of Medicine, National Academy of Sciences, National Academy of Engineering. On Being a Scientist: A Guide to Responsible Conduct in Research. 3. The National Academies Press; Washington, DC, USA: 2009. - PubMed
    1. National Research Council. The Responsible Conduct of Research in the Health Sciences. The National Academies Press; Washington, DC, USA: 1989. - PubMed
    1. Resnik DB. The Ethics of Science: An Introduction. Routledge; London: 1998.
    1. Federal Register. Public health service policies on research misconduct final rule. 2005 42 CFR part 93. http://www.ecfr.gov/cgi-bin/text-idx?SID=0b07ed68cf889962cae6c2b45d89150.... - PubMed
    1. Buyse M, Evans SJW. Fraud in clinical trials. In: Armitage P, Colton T, editors. Encyclopedia of Biostatistics. John Wiley; Chichester: 2005. pp. 2023–2031.

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