临床试验注册制度与循证医学

Clinical Trial Registration System and Evidence-Based Medicine

本文介绍了当前新药临床试验、院内制剂、上市后药物临床试验及其他类型临床试验的管理情况,世界卫生组织临床试验注册平台(WHO ICTRP)的结构和运作机制和全球临床试验注册制度建立概况,中国临床试验注册中心和中国临床试验注册与发表协作网及其运作机制;提出用循证医学基本哲学思想作为临床试验研究者的思想和行为准则,是临床试验真实性的内部保障系统。

This article briefly introduces the management of clinical trials of investigational new drugs, hospital-made preparations, post-marketing drugs and other types of clinical trials. The WHO International Clinical Trial Register Platform （WHO ICTRP）, Chinese Clinical Trial Register （ChiCTR） and Chinese Clinical Trial Registration and Publishing Collaboration （ChiCTRPC） are also described. People conducting trials are advised to apply the basic philosophy of evidence-based medicine in their implementation, which is considered to be one of the guarantees of the validity of clinical trials.