人工智能医疗器械临床试验设计与实施的挑战与对策  

Design and implementation of clinical trials on artificial intelligence medical devices:challenges and strategies

作　　者：龙囿霖 王心怡 郭琼 林逸飞[3] 黄进[1,2] 杜亮[1,2] LONG Youlin;WANG Xinyi;GUO Qiong;LIN Yifei;HUANG Jin;DU Liang(Medical Device Regulatory Research and Evaluation Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;Precision Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China)

机构地区：[1]四川大学华西医院医疗器械监管研究与评价中心,成都610041 [2]四川大学华西医院中国循证医学中心,成都610041 [3]四川大学华西医院精准医学中心,成都610041

出　　处：《中国循证医学杂志》2022年第12期1453-1458,共6页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:81873197、72074161);四川省科技厅项目(编号:2019YFS0194)。

摘　　要：与传统医疗器械相比,人工智能医疗器械由于具有人工智能技术的相关特性,在开展临床试验过程中面临着更大挑战。本文针对辅助诊断类人工智能医疗器械在临床试验各阶段面临的挑战和风险,提出相应的应对策略,旨在为我国开展高质量的人工智能医疗器械临床试验、缩短临床试验周期提供借鉴和参考。Compared with traditional medical devices,artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology.This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis,and put forward corresponding coping strategies,with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.

关 键 词：人工智能医疗器械 临床试验 设计与实施 挑战与对策 

分 类 号：R197.39[医药卫生—卫生事业管理]