摘要
2018年以来,国务院、海南省政府先后出台相关政策,针对博鳌乐城国际医疗旅游先行区开展的真实世界临床数据应用研究,其产生的真实世界证据可用于特许进口创新药械的注册申请。基于前期试点项目的实证研究,本文分析和总结了博鳌乐城创新药械真实世界数据研究的创新设计和创新技术应用,以期探索博鳌乐城创新药械真实世界数据研究的创新模式。
Since 2018,the State Council and the People’s Government of Hainan Province have issued a series of policies for conducting real world data research in Boao Lecheng,an international medical tourism pilot zone in China,to promote the application of real world evidence(RWE)in supporting special innovative imported drugs and medical devices approvals.Based on preliminary pilot RWE project in Boao Lecheng,in this article,we summarized the innovative study design and research methodologies used in the RWE research so as to explore a new research framework of RWE research in Boao Lecheng.
作者
任燕
姚明宏
姚晨
刘艳梅
贾玉龙
孙鑫
REN Yan;YAO Ming-hong;YAO Chen;LIU Yan-mei;JIA Yu-long;SUN Xin(Chinese Evidence-based Medicine Center West China Hospital,Sichuan University;Real World Data Research and Innovation Center of Boao Lecheng;Department of Biostatistics,Peking University First Hospital;Peking University Clinical Research Institute)
出处
《中国食品药品监管》
2020年第11期14-20,共7页
China Food & Drug Administration Magazine
基金
国家重点研发计划(2017YFC1700406和2017YFC1700400)
四川省青年科技创新研究团队(2020JDTD0015)
四川大学华西医院学科卓越发展1•3•5工程项目(ZYYC08003)
国家药品监督管理局“上市后药品的安全性监测和评价方法研究项目”(HXH2003033)。
关键词
博鳌乐城
真实世界数据研究
特许创新药械
临床评价
监管决策
Boao Lecheng
real world evidence
special innovative medical device
clinical evaluation
regulatory decision making
