真实世界证据生成的工具和方法：实用临床试验、电子知情同意书和数据链接。
Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages.
机构信息
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
出版信息
Rheum Dis Clin North Am. 2019 May;45(2):275-289. doi: 10.1016/j.rdc.2019.01.010.
Abstract
Real-world evidence requires use of new tools and methods to support efficient evidence generation. Among those tools are pragmatic trials, utilization of central/single institutional review board and electronic consent, and data linkages between diverse types of data sources (eg, a trial or registry to administrative claims or electronic medical record data). This article reviews these topics in the context of describing several exemplar use cases specific to rheumatology and provides perspective regarding both the promise and potential pitfalls in using these tools and approaches.
摘要
真实世界证据需要使用新的工具和方法来支持高效的证据生成。这些工具包括实用临床试验、中央/单一机构审查委员会的利用以及不同类型数据源（例如，试验或注册表与行政索赔或电子病历数据）之间的数据链接。本文在描述几个特定于风湿病学的范例用例的背景下，对这些主题进行了回顾，并就使用这些工具和方法的前景和潜在陷阱提供了观点。
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