| 真实世界研究外对照设置的方法学进展 |
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| 引用本文： | 李戈,杨智荣,赵厚宇,刘志科,宋海波,詹思延,孙凤. 真实世界研究外对照设置的方法学进展[J]. 医药导报, 2022, 0(1) |
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| 作者姓名： | 李戈 杨智荣 赵厚宇 刘志科 宋海波 詹思延 孙凤 |
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| 作者单位： | 天津中医药大学健康科学与工程学院;中国科学院深圳理工大学计算机科学与控制工程学院;英国剑桥大学临床医学院初级医疗中心;北京大学公共卫生学院流行病与卫生统计学系;国家药品监督管理局药品评价中心中药监测和评价部 |
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| 基金项目： | 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。 |
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| 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。
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| 关 键 词： | 真实世界研究 外对照 偏倚风险 |
Methodological Progress of External Control in Real-World Study |
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| LI Ge,YANG Zhirong,ZHAO Houyu,LIU Zhike,SONG Haibo,ZHAN Siyan,SUN Feng. Methodological Progress of External Control in Real-World Study[J]. Herald of Medicine, 2022, 0(1) |
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| Authors: | LI Ge YANG Zhirong ZHAO Houyu LIU Zhike SONG Haibo ZHAN Siyan SUN Feng |
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| Affiliation: | (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) |
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| Abstract: | 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. |
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| Keywords: | Real-world study External control Risk of bias |
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