中国循证医学杂志

中国循证医学杂志

真实世界证据在医疗器械临床研究中的应用

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真实世界数据(real-world data,RWD)在特定类别医疗器械的临床研究中可生成足够有质量的证据作为决策依据。本文阐述了传统随机对照试验在医疗器械临床研究领域中的局限性,归纳并剖析了真实世界证据(real-world evidence,RWE)在该领域的适用条件,梳理了美国 FDA 最新器械类 RWE 研究的数据要求,旨在为今后规范我国 RWE 在医疗器械领域的应用提供参考。

Real-world data (RWD) in clinical study on specific categories of medical devices can generate sufficient quality evidences which will be used in decision making. This paper discusses the limitations of traditional randomized controlled trials in clinical research of medical devices, summarizes the utilizing conditions of real-world evidence (RWE) for medical devices, interprets the new FDA guidance document about the characteristics of RWD for medical devices and in order to provide evidence for the use of RWE in medical devices in our country.

关键词: 真实世界数据; 真实世界证据; 医疗器械; 适用条件

Key words: Real-world data; Real-world evidence; Medical device; Applicable condition

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