真实世界证据

Real-world Evidence

  • 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。

     

    Abstract: 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.

     

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