摘要
目前,在全球范围内,基于真实世界数据开展真实世界研究获取真实世界证据,用以支持药品/医疗器械的临床和监管决策,已成为值得研究与关注的重要话题,而形成证据的关键环节是设置可比的对照。该文从外对照设置出发,探讨真实世界研究外对照定义、应用场景,应用外对照的研究设计、统计分析、偏倚评估及报告规范等方面内容,以期为相关研究获取高质量真实世界证据,及使用真实世界证据支持决策提供参考。
Evaluation of drug and medical device effectiveness using real-world study(RWS)based on real-world data(RWD)to obtain real-world evidence(RWE)has become an important topic in clinical and regulatory decision-making,in which one of the key issues is to find comparable controls.This paper discusses external control(EC),covering its definition,application scenarios,study design,statistical analysis,risk of bias and the report standards of the study with EC,to facilitate the generation and application of RWE for evidence-based decision-making in China.
作者
李戈
杨智荣
赵厚宇
刘志科
宋海波
詹思延
孙凤
LI Ge;YANG Zhirong;ZHAO Houyu;LIU Zhike;SONG Haibo;ZHAN Siyan;SUN Feng(Public Health Science and Engineering College of Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;College of Computer Science and Control Engineering,Shenzhen Institute of Advanced Technology,Chinese Academy of Sciences,Shenzhen 518055,China;Primary Care Unit,School of Clinical Medicine,University of Cambridge,Cambridge CB18RN,UK;Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,China;Department of TCM Monitoring and Evaluation,Drug Evaluation Center,National Medical Products Administration,Beijing 100022,China)
出处
《医药导报》
CAS
北大核心
2022年第1期38-43,共6页
Herald of Medicine
基金
国家自然科学基金资助项目(72074011)
中国药品监管科学行动计划第二批重点项目。
关键词
真实世界研究
外对照
偏倚风险
Real-world study
External control
Risk of bias
