临床试验注册制度与循证医学

doi:10.3736/jcim20070301

Abstract

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

Tai-xiang Wu, You-ping Li, Guan-jian Liu, Jing Li. Clinical trial registration system and evidence-based medicine. Journal of Chinese Integrative Medicine, 2007, 5(3): 229-233.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20070301

http://www.jcimjournal.com/EN/Y2007/V5/I3/229

[1]	国家食品药品监督管理局. 医疗机构制剂注册管理办法(试行). [2005-03-22]. .
	State Food and Drug Administration. The management of medical institute products. [2005-03-22]. [ 2005-03-22]. . Chinese.
[2]	Krleza-Jeric K, Chan AW, Dickersin K , et al. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement(part 1). BMJ, 2005,330(749):956-958
[3]	De Angelis C, Drazen JM, Frizelle FA , et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Stroke, 2005,36(4):924-925
[4]	李幼平, 吴泰相, 李静 , 等. 创建中国临床试验注册和发表机制的联合宣言. 中国循证医学杂志, 2006,6(6):393-394
	Li YP, Wu TX, Li J , et al. Joint statement for Chinese clinical trial registration and publishing system. Zhongguo Xun Zheng Yi Xue Za Zhi, 2006,6(6):393-394
[5]	吴泰相, 李幼平, 李静 , 等. 中国临床试验注册和发表机制及实施说明. 中国循证医学杂志, 2006,6(6):395-396
	Wu TX, Li YP, Li J , et al. Chinese clinical trial registration and publishing system, and explanation. Zhongguo Xun Zheng Yi Xue Za Zhi, 2006,6(6):395-396
[6]	Guyatt G, Rennie D. Users' guides to the medical literature: essentials of evidence-based clinical practice.Chicago: AMA Press, 2002.

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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

Clinical trial registration system and evidence-based medicine

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