利用补充真实世界数据研究获得更深层次的认识

发布时间：2018-09-01 18:36

【摘要】：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。
[Abstract]:With patients, health care workers, drug registrants and policy makers in urgent need of evidence about the safety and effectiveness of various diagnostic and therapeutic approaches in the real world, We need new research designs to evaluate such problems efficiently and effectively. At the same time, more and more second-hand data can be used to provide such evidence, such as electronic medical records and medical insurance data. Complementary real-world data use both secondary and primary data collected through doctors / patients and combine the two. Based on the existing data, the research of supplementing real world data can concentrate on collecting missing important information to satisfy the purpose of the research. This paper will introduce the research of supplementary real world data, including the elements of research and design, the advantages and limitations of the research, the main points of implementation and application examples, etc.
【作者单位】： Real-World
【分类号】：R95

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