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Perspectives on Central Statistical Monitoring in Risk Based Approach of Clinical Trials

Tomoyoshi Hatayama*, Seiichi Yasui

In recent years, Risk-Based Monitoring (RBM) approach has been receiving increased attention as the efficient method to ensure data quality in clinical trials. In RBM, Central Statistical Monitoring (CSM) has an important role to monitor the status of operational process in clinical trials and detect its abnormalities. Many of statistical methods for CSM are proposed so far, but most of those studies are proposed based on somewhat strong assumptions, in addition, its performance evaluations are not practical in real setting of clinical trials. Authors think that it is still imperfect to fit them to practical clinical trials. In this article, we focus to clearly articulating the current problems on CSM and the matters to consider for further consecutive study activities of CSM.