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中国临床试验CRO的发展与变革

Development and changes of CRO of clinical trials in China

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【作者】雷翔；王晓晖；李静；王蓓；赵晨；喻佳洁；李幼平；吴泰相；卞兆祥；商洪才；

【Author】 LEI Xiang;WANG Xiaohui;LI Jing;WANG Bei;ZHAO Chen;YU Jiajie;LI Youping;WU Taixiang;BIAN Zhaoxiang;SHANG Hongcai;Tianjin Taicheng Yaozhong Biomedical Technology Co., Ltd.;Dongzhimen Hospital, Beijing University of Chinese Medicine;School of Chinese Medicine, Hong Kong Baptist University;Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University;

【通讯作者】商洪才;

【机构】天津泰成耀中生物医药技术有限公司；北京中医药大学东直门医院；香港浸会大学中医药学院；四川大学华西医院中国循证医学中心；

【摘要】近年中国临床试验合同研究组织(CRO)发展迅速,在中国临床试验水平的提高和药物的研发中发挥了重要作用,但CRO行业的发展也还存在不足。本文讨论了临床试验CRO发展的有利因素、存在问题和发展方向,旨在引起政府监督管理部门和CRO行业的重视。更多还原

【Abstract】 In recent years, CRO has developed rapidly in China, and has played an important role in improving the level of Chinese clinical trials and drug development. However, the development of CRO industry also has problems.This paper discusses the beneficial factors of the main problems and the future direction of CRO, in attempt to attract the attention of government supervision and management departments and CRO industries.更多还原

【关键词】合同研究组织；中国；临床试验；
【Key words】 Contract research organization； China； Clinical trial；

【文献出处】中国循证医学杂志 ,Chinese Journal of Evidence-Based Medicine , 编辑部邮箱 ,2018年08期

【分类号】R197.1
【被引频次】16
【下载频次】932

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