刘晓清;孙晓川;
LIU Xiao-qing;SUN Xiao-chuan;Department of Infectious Diseases,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Unit of Teaching and Research of Clinical Epidemiology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Clinical Epidemiology Unit,International Clinical Epidemiology Network,Chinese Academy of Medical Sciences & Peking Union Medical College;Department of Internal Medicine,Pe

• 1:中国医学科学院北京协和医学院北京协和医院感染内科
• 2:中国医学科学院北京协和医学院北京协和医院临床流行病学教研室
• 3:国际临床流行病学网中国医学科学院北京协和医学院临床流行病学室
• 4:中国医学科学院北京协和医学院北京协和医院内科

摘要(Abstract)：

真实世界证据是在现实医疗环境中,通过优化分析来源于多种途径的数据而获得的证据。其与传统临床研究证据的本质区别在于获取数据的环境,而非研究方法或试验设计。与传统随机对照临床试验证据相比,真实世界证据具有结果外推性好、研究效率高等优势,可广泛应用于医疗产品有效性和安全性评价、临床实践过程分析等领域。近年来,随着信息技术的飞速发展和医学循证需求的持续增加,真实世界研究愈发受到人们重视,发展前景良好。
Real-world evidence is defined as information on health care that is derived from multiple sources outside typical clinical research settings. The essential difference between real-world evidence and evidence from traditionally randomized clinical trial is the setting where data is collected,but not the study method or design. Real-world evidence has a better external validity and research efficiency when compared to evidence from traditionally randomized clinical trials,and thus is widely used in the assessment of the safety and efficacy of a medical product,in the analysis of clinical practice,etc. In recent years,increasing importance has been attached to real-world research in the context of rapid development of information technology and growing need for clinical evidence,suggesting its good prospects in the future.

关键词(KeyWords)： 真实世界证据;传统随机对照临床试验证据
real-world evidence;evidence from traditionally randomized clinical trial

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 刘晓清;孙晓川;
LIU Xiao-qing;SUN Xiao-chuan;Department of Infectious Diseases,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Unit of Teaching and Research of Clinical Epidemiology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Clinical Epidemiology Unit,International Clinical Epidemiology Network,Chinese Academy of Medical Sciences & Peking Union Medical College;Department of Internal Medicine,Pe

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