• 1. Medical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
  • 2. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
  • 3. Precision Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
HUANG Jin, Email: michael.huangjin@gmail.com; DU Liang, Email: duliang0606@vip.sina.com
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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.

Citation: LONG Youlin, WANG Xinyi, GUO Qiong, LIN Yifei, HUANG Jin, DU Liang. Design and implementation of clinical trials on artificial intelligence medical devices: challenges and strategies. Chinese Journal of Evidence-Based Medicine, 2022, 22(12): 1453-1458. doi: 10.7507/1672-2531.202208108 Copy

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