关于在药物研发和监管中使用真实世界数据（RWD）和真实世界证据（RWE）的现状报告。
Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation.
机构信息
Clinical Pharmacology, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
ARJUNA Therapeutics, C/ XESTA №78-A2, PARQUE EMPRESARIAL NOVO MILLADOIRO - 15895 MILLADOIRO, A CORUÑA, Spain.
出版信息
Br J Clin Pharmacol. 2019 Sep;85(9):1874-1877. doi: 10.1111/bcp.14026. Epub 2019 Jul 10.
Abstract
Radically expanding use of real-world data (RWD) and real-world evidence (RWE) holds the potential to substantially impact drug development, pharmaceutical regulation, and payment within health care systems. Central to this is the reconfiguration of data gathering and transformation of data to information, which can be used as evidence for decision making. We discuss applications of this paradigm in the light of recent developments in both the United States and Europe on RWD and RWE.
摘要
真实世界数据（RWD）和真实世界证据（RWE）的广泛应用具有极大潜力，可能会对药物研发、药品监管和医疗保健系统内的支付方式产生重大影响。这一过程的核心是重新配置数据收集并将数据转化为信息，这些信息可用作决策证据。我们根据美国和欧洲最近在 RWD 和 RWE 方面的发展情况，讨论了这一模式的应用。
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