真实世界证据  

Real-world Evidence

作　　者：刘晓清[1,3,4] 孙晓川[2] 

机构地区：[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,北京100730 [2]中国医学科学院,北京协和医学院,北京协和医院内科,北京100730 [3]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,北京100730 [4]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,北京100730

出　　处：《协和医学杂志》2017年第4期305-310,共6页Medical Journal of Peking Union Medical College Hospital

摘　　要：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 evi-dence 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 atta-ched 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：真实世界证据 传统随机对照临床试验证据 

分 类 号：R-1[医药卫生]