中美监管实践中高风险医疗器械关键性研究的比较
omparison of Pivotal Studies for High-risk Medical Devices between China and the US
对中美高风险医疗器械的关键性研究（包括40个已上市的产品及部分正在开展的研究，涵盖冠脉介入、结构性心脏病、左心室辅助装置、神经调控以及电生理等领域）进行比较，可以看到我国开展的关键性研究设计相对简单，主要终点定量指标相对较多，样本量也相对较小。不同类别产品之间的关键性研究难以直接比较，但在高风险医疗器械的关键性研究开展前申办方与监管机构达成一致应该是我们今后努力的方向。
comparison of pivotal studies for high-risk medical devices between China and the US including 40 approved products and some undergoing studies, covering coronary intervention, structural heart disease, left ventricular assistant device, neuromodulation, and electrophysiology, showed that pivotal studies in China were relatively simple-designed, with more quantitative endpoints, and relatively small sample size. Direct comparison of pivotal studies between different class medical devices is difficult, but achieving consensus between sponsors and regulation administration agency before conducting of the pivotal studies should be our future direction.
医学研究方法医药卫生理论
医疗器械，高风险，关键性研究，注册监管
Medical device High risk Pivotal study Regulation administration
.中美监管实践中高风险医疗器械关键性研究的比较[EB/OL].(2023-12-09)[2025-08-02].https://chinaxiv.org/abs/202312.00126.点此复制
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