載藥醫(yī)療器械臨床試驗(yàn)是該類器械上市前最重要的考核指標(biāo)之一，作為藥物和器械的組合產(chǎn)品，要求研究者所掌握的專業(yè)知識(shí)和操作技能較普通醫(yī)療器械更高，試驗(yàn)質(zhì)量直接關(guān)系到產(chǎn)品上市后的安全性和有效性。通過(guò)分析醫(yī)療器械臨床試驗(yàn)和載藥醫(yī)療器械臨床試驗(yàn)的質(zhì)控要點(diǎn)，總結(jié)經(jīng)驗(yàn)，提出針對(duì)醫(yī)療器械臨床試驗(yàn)領(lǐng)域的相關(guān)建議。目前載藥醫(yī)療器械臨床試驗(yàn)在法規(guī)、人才培養(yǎng)、機(jī)構(gòu)監(jiān)管等層面存在一些不足之處，需在實(shí)踐過(guò)程中不斷改進(jìn)，以提升臨床試驗(yàn)質(zhì)量。

The drug-loaded medical device clinical trial is one of the most important evaluation indices for such devices before coming into the market. As a combination of drugs and devices, it requires investigators to master more professional knowledge and operating skills than medical apparatus, and trial quality is directly related to the safety and effectiveness of the products after they are marketed. Some relevant suggestions were proposed in the field of medical device clinical trials with summarizing experiences through analyzing the key points of quality control for clinical trials of medical instruments and those with medicines. There were still some deficiencies in the regulations, talent cultivation and site supervision of clinical trials for medical equipment containing drugs, which was necessary to be continuously improved in the practice of clinical trials, and improving the quality of clinical trials.

R944.5

國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)（2017ZX09304002）；上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院“四明醫(yī)院管理研究專項(xiàng)”（SGYYGL-202018）上海申康醫(yī)院發(fā)展中心《市級(jí)醫(yī)院醫(yī)企協(xié)同臨床試驗(yàn)管理項(xiàng)目》中藥新藥臨床試驗(yàn)質(zhì)量保證體系構(gòu)建研究（20CR4003B）