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Journal of Chinese Integrative Medicine ›› 2007, Vol. 5 ›› Issue (3): 229-233.doi: 10.3736/jcim20070301

• Editorial •     Next Articles

Clinical trial registration system and evidence-based medicine

Tai-xiang Wu, You-ping Li, Guan-jian Liu, Jing Li   

  1. Chinese Clinical Trial Register, Chinese Evidence-Based Medicine Centre of Ministry of Health, Chinese Cochrane Centre, International Clinical Epidemiology Network West China Resource and Training Center, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
  • Online:2007-05-31 Published:2007-05-15

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.

Key words: clinical trials, registration, clinical test for new drug development, post-market drugs, evidence-based medicine

CLC Number: 

  • R-01


类别 目的 时间 管理方式
新药临床试验,院内制剂 新药审批,上市前有效性、安全性和上市后有限样本量的Ⅳ期试验 上市前Ⅰ、Ⅱ、Ⅲ期和部分Ⅳ期试验 SFDA注册,政府强制管理,研究方案和结果均不公告
国家各级政府、科学基金立项的临床试验,临床工作者自己设计的临床试验,解决社会关注或重大健康和卫生事件(问题)的临床试验 上市后安全性、有效性、应急事件、学术研究等等 上市后至撤市前全过程的药物临床试验 尚无行政机构统一注册和管理




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