药物临床试验管理规范与医学伦理  

Good Clinical Practice and Medical Ethics

作　　者：曾繁典[1] ZENG Fandian(Tongji Medical College,Hauzhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院,武汉430030

出　　处：《医药导报》2020年第11期1466-1470,共5页Herald of Medicine

摘　　要：中国《药物临床试验质量管理规范》(GCP)新版于2020年7月1日正式实施。新版GCP以我国2003年版GCP实施以来积累的经验和汲取的教训为基础,以中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》为指引,参考国际人用药品技术要求协调理事会(ICH)GCP内容,对2003年版GCP进行了调整和增补,新版GCP更富针对性、规范性和指导力。该文归纳新版GCP实施要点,强调研究者手册和药物临床试验方案是体现临床试验科学性的核心文件。概括《世界医学大会赫尔辛基宣言》医学伦理核心精神,强调加强伦理委员会建设的基本要素,分析认真撰写和审查知情同意书对药物临床试验中落实医学伦理的重要意义。The new China's“Guideline for Good Clinical Practice(GCP)”was officially executed on July 1,2020.This article provides an overview of the revision base of the new GCP,focused on discussing the experience and lessons that we have received since 2003 GCP version has been executed in China.The revision prosses of GCP was guided by the opinions on the deepening the reform of the review and approval system to encourage innovation in pharmaceuticals and medical devices of the Office of central committee of Chinese Communist Party and the Office of the State Council.Besides,the new GCP is modified and supplemented by reference to the content of ICH GCP.The new edition of GCP of China has become more targeted,normative and instructive than before.This paper generalizes the main points for the application of the new version of GCP by highlighting that the investigator's brochure and drug protocol are the core documents to reflect the scientific characteristics of the clinical trial.Moreover,this article summarizes the core spirit of medical ethics of Helsinki Declaration of the World Medical Congress,emphasizes the basic elements of strengthening the construction of the Independent Ethics Committee,and further analyzes the importance of carefully writing and reviewing informed consent forms in the application of medical ethics in clinical trials of pharmaceuticals.

关 键 词：药物临床试验质量管理规范 伦理委员会 临床试验方案 申办者 研究者 知情同意书 

分 类 号：R95[医药卫生—药学]