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真实世界研究在医药领域的应用及研究方法
引用本文:秦雪妮, 陈维生, 邵华, 廖俊. 真实世界研究在医药领域的应用及研究方法[J]. 药学进展, 2021, 45(7): 512-523.
作者姓名:秦雪妮  陈维生  邵华  廖俊
摘    要:
近年来,随着医学研究多样化证据的需求增加和大数据、人工智能技术的支持,真实世界研究成为世界学术界和产业界关注的焦点。为充分认识真实世界研究在医药领域的应用情况,并探究真实世界研究方法的差异和难点,结合PubMed、中国知网已发表的文献,按临床问题、药品问题、中医药问题三方面应用情况分类,并对其中使用的研究设计、样本量大小、统计分析等方法进行归纳总结,讨论研究中的注意事项并提供了解决办法,以期使真实世界研究发挥最大效用。

关 键 词:真实世界研究  真实世界数据  真实世界证据  随机对照试验
收稿时间:2021-05-20

Application and Research Method of Real World Research in the Medical Field
QIN Xueni, CHEN Weisheng, SHAO Hua, LIAO Jun. Application and Research Method of Real World Research in the Medical Field[J]. Progress in Pharmaceutical Sciences, 2021, 45(7): 512-523.
Authors:QIN Xueni  CHEN Weisheng  SHAO Hua  LIAO Jun
Abstract:
In recent years, the increasing demand for diverse evidence in medical research and the support of big data and artificial intelligence technologies have pushed real world research into the focus of attention around the world. To fully understand the application of real world research in the medical field and explore the differences and difficulties in methodology, this review has combined the published papers from PubMed and CNKI, and classified them into three categories:clinical problems, drug problems, and traditional Chinese medicine(TCM) problems. In addition, the research design, sample size, statistical analysis and other methods used in the study have been summarized, with problems discussed and solutions provided, so as to make the most of the real world research.
Keywords:real world study  real world data  real world evidence  randomized controlled trial
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