药物临床试验监查的新方式

New approaches of clinical trial monitoring

监查是药物临床试验进行质量控制的重要措施之一,其中现场监查是最为常见的一种传统监查访视方式。随着电子数据采集系统的广泛应用,临床试验复杂性增加,第三方参与增多等新变化,欧美的制药企业、药监部门及学术界为了比较监查中所用方法的成本效益比,最大化利用监查资源,开展了一系列调研和探讨活动,建议:采用远程的集中化电子数据监查;识别影响临床试验质量的关键风险因素,制定基于风险分析的监查应该成为监查工作的必然步骤之一;应更灵活地选择监查频率、程度及方式;监管机构、医疗及学术机构、制药企业等多方需要关注新出现的监查方法,致力于优化,探索最合适的监查方式,来提高临床试验质量和效率。

Monitoring is one of the critical quality control approaches in the conduct of clinical trials. Tra- ditional on-site monitoring is a frequently employed procedure. With the wide application of electronic capture sys- tem, increased complexity of clinical trials, and the involvement of the third parties, biopharmaceutical companies, regulatory agencies, and academic groups in US and Europe have initiated a series of survey and discussions in or- der o compare the cost-effectiveness and make the best use of the resources. The proposed suggestions were as fol- lows： The more efficient centralized off-site monitoring should be encouraged. In addition, it is necessary to identify the key risk factors by risk-based analysis monitoring. Increasing the flexibility of monitoring frequency, depth and methods has also been recommended. Stakeholders should explore appropriate new monitoring approaches through broad adoption, thus to improve the quality and efficiency of clinical trials.