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

TitleAre these data real? Statistical methods for the detection of data fabrication in clinical trials
Publication TypeJournal Article
Year of Publication2005
AuthorsAl-Marzouki, S, Evans, S, Marshall, T, Roberts, I
JournalBMJ: British Medical Journal
Volume331
Issue7511
Pagination267-270
Type of ArticleArticle
Publication Languageeng
ISSN Number09598146
Accession Number17836885
KeywordsCARDIOVASCULAR , Clinical , Data , data management , Drugs , MEDICINE , Methodology , Misconduct , research , STATISTICS
AbstractTo test the application of statistical methods to detect data fabrication in a clinical trial, the authors looked at the baseline comparisons of means and variances of cardiovascular risk factors, digit preference overall and its pattern by group from two clinical trials: a trial of a dietary intervention for cardiovascular disease and a trial of a drug intervention for the same problem. They found that in the dietary intervention trial, variances for 16 of the 22 variables available at baseline were significantly different, and 10 significant differences were seen in means for these variables. Some of these P values were extraordinarily small. Distributions of the final recorded digit were significantly different between the intervention and the control group at baseline for 14/22 variables in the dietary trial. In the drug trial, only five variables were available, and no significant differences between the groups for baseline values in means or variances or digit preference were seen. The authors concluded that several statistical features of the data from the dietary trial are so strongly suggestive of data fabrication that no other explanation is likely.
NotesAl-Marzouki, Sanaa 1 Evans, Stephen 2; Email Address: stephen.evans@Lshtm.ac.uk Marshall, Tom 3 Roberts, Ian 4; Affiliation: 1: Research student, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT 2: Professor of pharmacoepidemiology, Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT 3: Senior lecturer in medical statistics, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT 4: Professor of epidemiology and public health, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT; Source Info: 7/30/2005, Vol. 331 Issue 7511, p267; Subject Term: CLINICAL trials; Subject Term: MEDICINE -- Research; Subject Term: RESEARCH -- Moral & ethical aspects; Subject Term: DATA analysis; Subject Term: STATISTICS; Subject Term: METHODOLOGY; Subject Term: CARDIOVASCULAR system -- Diseases; Subject Term: DRUGS -- Testing; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 4p; Illustrations: 4 Charts; Document Type: Article
DOI10.1136/bmj.331.7511.267
Short TitleAre these data real? Statistical methods for the detection of data fabrication in clinical trials
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