药物临床试验机构专家委员会运行模式探讨  

Operational mode of the Expert Committee on Clinical Trial in medical institutions

作　　者：李博[1] 高蕊[1] 李睿[1] 陆芳[1] 訾明杰[1] 李庆娜[1] 唐旭东[1] 

机构地区：[1]中国中医科学院西苑医院药物临床试验机构,北京100091

出　　处：《中国新药杂志》2015年第19期2188-2190,2196,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2012ZX09303-010-002);国家自然科学基金青年项目(81303151)

摘　　要：探讨药物临床试验机构专家委员会的建立及运行模式。首先回顾药物临床试验机构的产生源流及作用,阐述药物临床试验机构对于临床试验管理的重大意义;其次,介绍中国中医科学院西苑医院药物临床试验机构专家委员会的建立,运行模式及实践,探讨专家委员会对于完善药物临床试验机构,尤其是试验启动前的意义;最后,从实践中可以看出,不断完善的专家委员会有利于优化临床研究方案的优化,有利于药物临床试验的建设,从而保障临床研究方案设计符合科学、伦理要求。希望将来能建立地区级乃至国家级的临床试验专家委员会。To explore the establishing and operating mode of the Expert Committee on Clinical Trial（ ECCT）. Firstly,we recalled the generation of the medical institutions conducting clinical trials for human used drugs,and explained the substantial significance. Then,we introduced the clinical test run mode of the ECCT of Xiyuan Hospital,China Academy of Traditional Chinese Medical Sciences,and explored the ECCT function on the medical institution conducting clinical trials for human used drugs,specially for the clinical trail start. After the practicing,we found that continuous improvement of the ECCT helps optimizing of the clinical research program. ECCT can protect clinical research programs designed. We hope that we can set up the National ECCT for clinical trials in future.

关 键 词：药物临床试验机构 专家委员会 药物临床试验质量管理规范(GCP) 临床试验管理 

分 类 号：R95[医药卫生—药学]