多国或一国多中心临床试验联合伦理审查机制研究

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (8): 470-476.

多国或一国多中心临床试验联合伦理审查机制研究

魏芬芳, 孙宇昕, 郑永侠, 杨悦^*

沈阳药科大学，辽宁沈阳 110016

收稿日期:2017-06-05 修回日期:2017-09-26 出版日期:2017-08-20 发布日期:2017-09-26
通讯作者: 杨悦，女，博士，教授，博导，药事法规与药品政策。E-mail：yyue315@vip.126.com。
作者简介:魏芬芳，女，在读硕士，药事管理。

Study on the Joint Review Mechanism of Multi-regional Clinical Trial

WEI Fen-fang, SUN Yu-xin, ZHENG Yong-xia, YANG Yue^*

Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2017-06-05 Revised:2017-09-26 Online:2017-08-20 Published:2017-09-26

摘要/Abstract

摘要： 目的探讨中国建立多国或一国多中心临床试验（MRCT）联合伦理审查机制的问题。方法比较分析美、英及中国台湾地区MRCT联合伦理审查机制的法律法规、运作情况及审查模式。结果我国MRCT伦理审查机制尚未建立，美国、英国和中国台湾地区主要通过中心伦理委员会和区域伦理委员会的独立审查和联合审查机制避免伦理审查重复的问题。结论多中心临床试验联合伦理审查机制是国际大趋势，我国大陆建立MRCT联合伦理审查机制须循序渐进。

关键词: 临床试验, 联合审查机制, 受试者

Abstract: Objective To explore the establishment of Chinese multi-regional clinical trial (MRCT) joint ethical review mechanism. Methods The laws, regulations, operation and review mode of MRCT joint ethical review mechanism in the United States, Britain and Taiwan were analyzed. Results The ethical review mechanism of MRCT has not yet been established in China. The United States, the United Kingdom and Taiwan have adopted the independent review and joint review mechanism of the Center Ethics Committee and the Regional Ethics Committee to avoid duplication of ethical review. Conclusion The ethical review mechanism of MRCT is international trends, and China should be established the mechanism step by step.

Key words: clinical trial, joint review mechanism, subjects

中图分类号:

魏芬芳, 孙宇昕, 郑永侠, 杨悦 . 多国或一国多中心临床试验联合伦理审查机制研究[J]. 中国药物警戒, 2017, 14(8): 470-476.

WEI Fen-fang, SUN Yu-xin, ZHENG Yong-xia, YANG Yue. Study on the Joint Review Mechanism of Multi-regional Clinical Trial[J]. Chinese Journal of Pharmacovigilance, 2017, 14(8): 470-476.

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