中国临床试验数据监管改革的分析与思考  

Analysis and thinking on the reform of clinical trial data supervision in China

作　　者：佟梁慧 张帆[2] 孙潭霖 张洋洋 张志娟 宋瑞霖 TONG Lianghui;ZHANG Fan;SUN Tanlin;ZHANG Yangyang;ZHANG Zhijuan;SONG Ruilin(Center for Policy Research,China Pharmaceutical Innovation and Research Development Association,Beijing 100007,China;Institude of Regulatory,China Pharmaceutical University,Nanjing 211198,Jiangsu Province,China;The Research Center of National Drug Policy and Ecosystem,China Pharmaceutical University,Nanjing 211198,Jiangsu Province,China)

机构地区：[1]中国医药创新促进会政策研究中心,北京100007 [2]中国药科大学监管科学研究院,江苏南京211198 [3]中国药科大学国家药物政策与产业经济研究中心,江苏南京211198

出　　处：《世界临床药物》2023年第8期882-890,共9页World Clinical Drug

摘　　要：近年来我国深入开展临床试验监管改革,建立与国际接轨的临床试验管理体系,但美国等西方国家少数人士仍然以2016年我国媒体就临床试验自查核查情况主动披露的新闻报导为依据,无视药品监管改革成果,对我国现有药物临床试验质量提出质疑,对中国医药创新国际化发展造成负面影响。该文对2015年临床试验数据自查核查工作启动背景和2017年总结报告中相关数据进行深入研究,揭示当时临床试验数据自查核查实际情况,分析事件背后所反映出的政策原因,提出继续优化药物临床试验管理的政策建议。In recent years,China has carried out in-depth clinical trial supervision reform and established a clinical trial management system that is in line with international standards.However,a minority from the United States and other western countries still take the news reports voluntarily disclosed by Chinese media on the self-inspection&verification of clinical trials in 2016 as the basis,ignoring the achievements of China’s drug regulatory reform,questioning the quality of existing pharmaceutical clinical trials in China,which has a negative affect the internationalization development of China’s pharmaceutical innovation.This paper conducted an in-depth study on the work of launching background of the self-inspection&verification of clinical trial data in 2015 and the relevant data in the 2017 summary report,revealed the actual situation of the work at that time,analyzed the policy background behind the problems,and put forward policy recommendations to continue to optimize the management of pharmaceutical clinical trials.

关 键 词：临床试验数据 自查核查 药品注册分类 临床试验管理 人用药品技术要求国际协调理事会 

分 类 号：R95[医药卫生—药学]