Clinical Trial Registration System and Evidence-Based Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

 WU Taixiang ¹ , LI Youping ¹ , LIU Guanjian ¹ , LI Jing ¹ , ZHONG Zihong ² , JIA Wannian ³

1. Chinese Clinical Trial Register, Chinese Evidence-Based Medicine Centre of Ministry of Health, Chinese Cochrane Centre, International Clinical Epidemiology Network Resource and Training Center, West China Hospital, Sichuan University, Chengdu, 610041, China 2. Chinese Academy of Medical Sciences, Peking Union Medical College3. The Editorial Board of “PLA Journal of Medicine”;

Corresponding author：

WU Taixiang, Email: txwutx@hotmail.com

Keywords：

Clinical trials; Registration; Clinical trials of investigational new drugs; Clinical trials of post-marketing drugs; Evidence-based medicine

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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.

Citation： WU Taixiang,LI Youping,LIU Guanjian,LI Jing,ZHONG Zihong,JIA Wannian. Clinical Trial Registration System and Evidence-Based Medicine. Chinese Journal of Evidence-Based Medicine, 2007, 07(4): 239-243. doi: Copy

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1. State Food and Drug Administration: The management of medical institute products. Issued in March 22, 2005. http://www.gov.cn/gongbao/content/2006/content_292146.htm.
2. http://www3.xinhuanet.com/chinanews/2007-01/12/content_9031081.htm.
3. Wu TX, Li YP, et al: Investigation for the quality of Chinese Claimed “RCTs”. Oral presentation in 14th Cochrane Colloquium, Dublin, Oct. 2006.
4. Li YP, Wu TX, Li Jing, et al. Joint Statement of Establishing Chinese Clinical Trial Registration and Publishing System. Chin Evid-Based Med, 2006, 6(6): 393-394.
5. Wu Taixiang, Li Youping, Li Jing, et al. Chinese Clinical Trial Registration and Publishing System, and Explanation. Chin J Evid-Based Med, 2006, 6(6): 395-396.
6. 中华人民共和国药品监督管理局：医疗机构制剂注册管理办法（试行）2005年3月22日；.
7. 北京成立医疗机构制剂临床试验伦理委员会.新华网,2007.1.30.
8. 吴泰相, 李幼平, 等. 中国标称随机对照试验质量调查 Cochrane Colloquium 14th, Dublin, Oct. 2006.
9. OTTAWA STATEMENT, http://ottawagroup.ohri.ca/.
10. Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors: http://www.icmje.org/clin_trial.pdf.
11. 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.
12. 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.
13. Guyatt G, Rennie D: Users’ Guides to the Medical Literature. Essentials of Evidence-Based Clinical Practice. AMA Press, Third printing January, 2004.

Chinese Journal of Evidence-Based Medicine

Clinical Trial Registration System and Evidence-Based Medicine

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