临床试验基于风险的管理研究进展

随着临床研究信息技术的普及，临床试验数据处理与统计方法的应用发展，以及通过远程的方法处理现场的工作和计算机自动化取代人工，临床研究行业逐步演变出了基于风险的管理模式。20年后的今天，人用药品注册技术要求国际协调会议（international conference on harmonization of technical requirements for registration of pharmaceuticals for human use，ICH）发布了新版药物临床试验质量管理规范（good clinical practice，GCP），欧美监管部门也颁发了临床试验监管新的指导原则，临床研究行业正在催生一个重大的变革。在临床试验基于风险的管理模式中，信息化技术和专业化的执行团队都将扮演重要的角色。

Research progress on risk-based management in clinical trials

With the evolutions of information technology, the application and development of data management and statistical methods, and onsite tasks resolved by remote approaches, human work replaced by computer automation, a new project management model of risk based management gradually evolved out in clinical research industry. Now, twenty years later, ICH issued a new version of the GCP, and the European and American regulators also issued new guidelines for quality management in clinical trials. These policies and regulations will result in great changes in clinical research industry. In the risk based management model of clinical trials, information technology and professional implementation personnel will both play the important roles.