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的结构和运作机制以及全球临床试验注册制度的建立概况,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;提出以循证医学基本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。

The authors briefly introduced the management of clinical test for new drug development, clinical trials for drugs prepared in hospital and post-market drugs, and other types of clinical trials. The mechanism of WHO International Clinical Trial Register Platform （WHO ICTRP）, Chinese Clinical Trial Register （ChiCTR） and Chinese Clinical Trial Registration and Publishing Collaboration （ChiCTRPC） were also introduced. The authors suggested the trialists to practice the basic philosophy of evidence-based medicine as the rules of their thought and action, and considered that this is the inner guarantee system for the validity of clinical trials.