真实世界证据在医疗器械临床研究中的应用

Utilization of real-world evidence in clinical research of medical devices

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