协和医学杂志

2017, v.8(Z2) 305-310

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真实世界证据
Real-world Evidence

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

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

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作者(Author): 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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