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随着患者、医护人员、药品注册人员和政策决定者对现实世界中各种诊疗手段的安全性和有效性相关证据的迫切需求,我们需要新的研究设计来高效有效地对此类问题进行评估。与此同时,越来越多的二手数据可以用来提供此种相关证据,常用的二手数据包括电子医疗档案和医疗保险数据等。补充真实世界数据研究同时利用了现有二手数据和通过医生/患者收集的一手数据,并将两者进行结合。在现有数据的基础上,补充真实世界数据研究可以集中精力收集缺失的重要信息来满足研究目的。本文将对补充真实世界数据研究进行介绍,包括研究设计要素,研究的优点和局限性,实施要点以及应用实例等。
With the pressing needs of patients, health care workers, drug registrants and policy makers for evidence of the safety and efficacy of various treatments in the real world, we need new research designs to evaluate such issues efficiently and effectively . In the meantime, more and more second-hand data can be used to provide such evidence, commonly used second-hand data including electronic medical records and medical insurance data. Replenishment of real-world data The study uses both existing available data and primary data collected by physicians / patients and combines the two. Based on available data, research that complements real-world data can focus on missing missing information to meet research purposes. This article will introduce the research that complements real-world data, including the study of design elements, the pros and cons of research, implementation highlights, and application examples.