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

Tomoyoshi Hatayama, Seiichi Yasui
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Abstract

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.
基于风险的临床试验方法的中心统计监测展望
近年来,基于风险的监测(Risk-Based Monitoring, RBM)方法作为保证临床试验数据质量的有效方法受到越来越多的关注。在RBM中,中央统计监测(CSM)在监测临床试验操作过程的状态和发现其异常方面具有重要作用。目前提出了许多CSM的统计方法,但这些研究大多是建立在一些强假设的基础上,而且其性能评估在临床试验的实际环境中并不具有实用性。作者认为,将它们应用于实际的临床试验仍不完善。在本文中,我们重点阐述了当前CSM研究中存在的问题,以及进一步开展CSM研究活动需要考虑的问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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