Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

4.1 Introduction

Fraud in clinical trials is thought to be rare, though its prevalence is likely underestimated due to previously unavailable or limited tools and training for diagnosis, and fear over negative publicity [1]. However, several examples of fraudulent activity are available in the literature. Perceived misconduct was identified in a trial examining the effectiveness of a dietary intervention on reducing the risk of cardiovascular deaths [2]. After failing to get cooperation from the manuscript author to address perceived inconsistencies, a detailed analysis of the data was performed that identified major differences in baseline characteristics and digit preference among the trial arms [3]. In the National Surgical Adjuvant Breast ...