摘要
真实世界数据研究近年来发展迅速,但目前对其认识和理解仍然还存在诸多误区。为推动真实世界数据研究的标准化,本文对真实世界数据的分类进行了更新和进一步明确,提出了真实世界数据研究的两种常用模式,构建了研究型数据体系框架,尤其厘清了对登记数据库的误区和问题,对真实世界数据研究的未来发展方向进行了展望。
Real-world data studies have experienced rapid development in recent years,however,misunderstandings persist.This paper aims to improve practice and promote standardization by updating the categorization of real-world data,proposing two conceptual frameworks for conducting real-world data studies,developing the concepts of research data infrastructure and clarifying the misconceptions on registry database,and discussing future development.
作者
王雯
谭婧
任燕
李玲
沈传勇
田春华
宋海波
王涛
高培
彭晓霞
温泽淮
舒啸尘
王丽
刘梅
何俏
邹康
孙鑫
WANG Wen;TAN Jing;REN Yan;LI Ling;SHEN Chuanyong;TIAN Chunhua;SONG Haibo;WANG Tao;GAO Pei;PENG Xiaoxia;WEN Zehuai;SHU Xiaochen;WANG Li;LIU Mei;HE Qiao;ZOU Kang;SUN Xin(Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;Center for Drug Reevaluation,National Medical Products Administration,Beijing 100000,P.R.China;Department of Epidemiology and Biostatistics,Peking University Health Science Center,Beijing 100191,P.R.China;Center for Clinical Epidemiology and Evidence-based Medicine,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,P.R.China;Key Unit of Methodology in Clinical Research,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,P.R.China;Department of Epidemiology and Biostatistics,School of Public Health,Medical College of Soochow University,Suzhou 215123,P.R.China;Institute of Basic Medical Sciences,Chinese Academy of Medical Sciences,Beijing 100005,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2020年第11期1241-1246,共6页
Chinese Journal of Evidence-based Medicine
基金
国家重点研发计划项目(编号:2017YFC1700406和2017YFC1700400)
四川省青年科技创新研究团队项目(编号:2020JDTD0015)
四川大学华西医院学科卓越发展1·3·5工程项目(编号: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”(编号:HX-H2003033)。
关键词
真实世界数据与研究
研究型数据体系
标准化
Real-world data and studies
Research data infrastructure
Standardization
