通过基于风险评估统计模型的中心化监查优化抗肿瘤药物临床试验质量管理

Centralized Monitoring Driven by Statistical Risk Assessment Models for Oncology Clinical Trial Quality Management

ICH和我国法规均推荐临床试验进行风险质量管理,以提升临床试验质量管理的效率。本文在不建立新平台和新系统的情况下,以统计算法为驱动进行探索,在肿瘤临床试验中建立中心风险评估统计模型,通过统计软件和日常办公软件实施中心化监查,并对实施考量、计划制定、工作流程,以及基于评估结果的风险管理等进行阐述;以期为创新药物企业提供一种科学严谨且资源投入较低的方式、一种实施中心化监查和中心化质量控制的模式,供行业参考。

Both ICH and Chinese regulations recommend risk-based quality management for clinical trials to improve efficiency.This paper explores assessing site risks in oncology clinical trials with statistical models and implementing centralized monitoring using common office software,without acquiring new platforms or systems.Implementation considerations are presented including plan development,workflow,and risk management actions based on evaluation results.This paper aims to provide a scientific and rigorous way for small to medium size biotech companies to conduct risk-based centralized monitoring and quality management in a cost-effective way.