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Al-Marzouki, S, Evans, S, Marshall, T and Roberts, I (2005)

Are these data real? Statistical methods for the detection of data fabrication in clinical trials

Brit. Med. J 331, pp. 267-270.

ISSN/ISBN: Not available at this time. DOI: 10.1136/bmj.331.7511.267

Abstract: INTRODUCTION: Most statistical analyses of clinical trials are undertaken on the presumption that the data are genuine. Large accidental errors can be detected during data analysis, but if people are trying to “make up” data they are likely to do it in such a way that it is not immediately obvious, avoiding any large discrepancies. Nevertheless, fraudulent data have particular statistical features that are not evident in data containing accidental errors, and several analytical methods have been developed to detect fraud in clinical trials. The BMJ has taken a general interest in this field and has published a book on fraud and misconduct, now in its third edition, which has a chapter on statistical methods of detection of fraud. In this paper we use statistical techniques to examine data from two randomised controlled trials. In one trial, the possibility of scientific misconduct had been raised by BMJ referees, based on inconsistencies in calculated P values compared with the means, standard deviations, and sample sizes presented. For comparison, we used the same methods to analyse a second trial for which there were no such concerns. We were not involved in either trial.

@article {, AUTHOR = {Al-Marzouki, Sanaa and Evans, Stephen and Marshall, Tom and Roberts, Ian}, TITLE = {Are these data real? Statistical methods for the detection of data fabrication in clinical trials}, JOURNAL = {BMJ}, FJOURNAL = {British Medical Journal}, YEAR = {2005}, VOLUME = {331}, NUMBER = {7511}, PAGES = {267--270}, MONTH = {July}, DOI = {10.1136/bmj.331.7511.267}, }

Reference Type: Journal Article

Subject Area(s): Statistics