01984nas a2200289 4500008004100000022001300041245010200054210006900156300001200225490000800237520118300245653001901428653001301447653000901460653002001469653001001489653001301499653001601512653001501528653001301543653001501556100002301571700001901594700001801613700001701631856004601648 2005 eng d a0959814600aAre these data real? Statistical methods for the detection of data fabrication in clinical trials0 aAre these data real Statistical methods for the detection of dat a267-2700 v3313 aTo 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. 10aCARDIOVASCULAR10aClinical10aData10adata management10aDrugs10aMEDICINE10aMethodology10aMisconduct10aresearch10aSTATISTICS1 aAl-Marzouki, Sanaa1 aEvans, Stephen1 aMarshall, Tom1 aRoberts, Ian uhttp://ethics.iit.edu/eelibrary/node/8281