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

2.1 Introduction

Recent interest in risk-based monitoring (RBM) is driven primarily by the increasingly unsustainable costs of conducting clinical trials [1,2]. But what is driving these expenses? Eisenstein et al. report that 25–30% of the costs of two hypothetical cardiovascular clinical trials involve site-management activities [3]. Tantsyura and coauthors report that up to 30% of a trial’s budget can be consumed by site monitoring [4]. A Swedish survey estimates that 50% of a trial’s costs are attributable to efforts related to International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) activities, half of which are consumed by source data verification (SDV) [5,6,7]. Given that SDV is increasingly viewed to have little to ...