Ensuring Data Quality and Identifying Potential Fraud in Clinical Trials
*Nancy L. Geller, National Heart, Lung, and Blood Institute 

Keywords: fraud detection

In 2000 Ranstam, et al. reported on a survey of clinical biostatisticians on fraud in medical research (Clinical Trials, 2000). Although the survey was small and the response rate low, half of those responding reported knowing of at least one fraudulent project in their proximity in the past ten years and this rate was notably higher than had been reported by previous surveys with similar response rates. The incidence of fraud appears to be increasing. Several examples of fraud since the Ranstam publication will be given in which we examine how fraud has been detected and how long it took. Inquiries into publication fraud have been set off by an allegation (e.g. graduate students alleging data disappearance) or a strange and unexpected coincidence (e.g., consent forms missing). Statisticians are in a unique position to aid in the detection of fraud, but should play a more active role than attempting to detect fraud after the fact. One should be especially wary of results that appear to be "too good to be true." It is wise to undertake certain routine simple comparisons in all of our clinical trials to be assured that data or individual centers don’t show unusual patterns. Making clinical trial data and computer code available to others promptly will allow verification of reported results.