国际临床试验规范化实施过程及其在中医药领域的应用  

Implementation Process Standardization of International Clinical Trials and Its Application in Chinese Medicine Field

作　　者：沈文娟 张跃辉 张多加 文雁 贾丽妍 刘建平[2] 吴效科 张杨 SHEN Wenjuan;ZHANG Yuehui;ZHANG Duojia;WEN Yan;JIA Liyan;LIU Jianping;WU Xiaoke;ZHANG Yang(First Hospital Affiliated to Heilongjiang University of Chinese Medicine, Harbin, 150036;Evidence-based Medicine Center Beijing University of Chinese Medicine)

机构地区：[1]黑龙江中医药大学附属第一医院 [2]北京中医药大学循证医学中心

出　　处：《中医杂志》2018年第8期649-653,共5页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局中医药行业科研专项(201107005);黑龙江省自然科学基金(H2015046);黑龙江省高校青年创新人才培养计划(UNPYSCT-2016216;UNPYSCT-2016218)

摘　　要：临床研究的规范化实施是评估研究方案有效性的重要保障。对国际临床试验实施组织构架及研究流程进行概述。以《针刺联合克罗米芬对多囊卵巢综合征无排卵妇女活产的影响:国际合作随机对照试验》为例,介绍黑龙江中医药大学附属第一医院妇科在中医临床研究实施过程中采用国际化的组织管理模式、注重实施准备、重视伦理复审与注册更新、定期召开方案执行委员会会议、采用现场监查与国际联合监查等方法,进行规范化实施的探索与创新,以期为中医药临床研究国际化提供参考。The standardized implementation of clinical research is an important guarantee to evaluate the effectiveness of the study protocol. This article is to summarize the organization structure and research process of international clinical trial implementation. Taking impact of acupuncture combined with clomiphene on polycystic ovarian syndrome anovulation women＇ s live birth： international cooperative randomized controlled trial（ PCOSAct） for example,this article introduces exploration and innovation of standardization implementation in department of gynaecology in First Hospital Affiliated to Heilongjiang University of Chinese Medicine in the process of clinical research of Chinese medicine,by adopting internationalized organizational management model,emphasizing the implementation preparation,emphasizing ethics retrial and registration update,regular meeting of steering committee,as well as adopting the methods of site inspection and international joint inspection,to provide reference for Chinese medicine clinical research internationalization.

关 键 词：临床试验 中医药 规范化 

分 类 号：R24[医药卫生—中医临床基础]