ICH-GCP E6(R2)指导下的临床试验伦理学思考  

Thinking on Clinical Trial Ethics under the Guidance of ICH-GCPE6(R2)

作　　者：侯艳红[1,2] 徐伟 林强[2] HOU Yan-hong;XU Wei;LIN Qiang(International Pharmaceutical Business School,China Pharmaceutical University,Jiangsu Nanjing 211198,China;Heze stem cell genetic engineering Co.,Ltd,Jiangsu Nanjing 210000,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]江苏和泽干细胞基因工程有限公司,江苏南京210000

出　　处：《中国药物评价》2020年第1期66-70,共5页Chinese Journal of Drug Evaluation

基　　金：中国药科大学“双一流建设“科技创新团队项目(CPU2018GY43);中国博士后科学基金(2019M661701)。

摘　　要：临床试验(Clinical trail)是指按照预先制订的方案,在人体进行的与生物医学或健康相关的研究,以揭示试验药物的作用、不良反应、试验药物在人体的吸收、分布、代谢和排泄,目的是确定试验药物在特定的给药方案下,对特定的适用证人群的疗效与安全性.临床试验通常会产生伦理方面的问题.ICH-GCP(临床试验管理规范指导原则)是关于药品临床试验的质量管理规范(Good Clinical Practice,GCP),其中关于临床试验的伦理准则的相关规定在E6中涉及.本文分析ICH-GCP E6(R2)指南中与伦理相关的条款,将条款与临床试验遵循的伦理原则一一对应,同时对ICH-GCP E6(R2)需要改进之处进行了探讨.Objective:Clinical trials refer to a biomedical or health-related study conducted in the human body in accordance with a pre-established protocol to reveal the effects of the test drug,adverse reactions,absorption,distribution,metabolism,and excretion of the test drug in the human body.The goal is to determine the efficacy and safety of the test drug forpatients under a specific dosing regimen.Clinical trials often raise ethical issues.ICH-GCP is a Good Clinical Practice(GCP)for clinical trials of drugs,and the relevant provisions on ethical guidelines for clinical trials are covered in E6.This article analyzes the ethics-related provisions of the ICH-GCP E6(R2)guidelines,which correspond to the ethical principles followed in clinical trials,and explores improvement aspects in ICH-GCP E6(R2).

关 键 词：人用药品注册技术要求国际协调会议(ICH) 临床试验管理规范(GCP) E6(R2) 伦理思考 

分 类 号：R95[医药卫生—药学]