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人工智能临床试验透明化的现状及挑战

The Current Status and Challenges of Transparency in Artificial Intelligence Clinical Trials

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从临床试验注册、数据共享和结果报告3个方面阐述了人工智能临床试验透明化的现状:人工智能临床试验的注册率很低,合格的临床试验注册更少;虽然已有一些临床试验数据和代码共享平台,但大部分人工智能临床研究的原始数据和代码的公开获取受限;人工智能临床试验报告的透明度和完整性尚待提高,报告规范的依从性较差.期待通过加强数据保护、构建责任监管框架和制度、加强研究人员的教育和培训以及建立统一的数据共享平台等措施,进一步提高人工智能临床试验的透明化,促进人工智能的临床应用.
This paper elaborates on the current status of transparency in artificial intelligence(AI)clinical trials from three aspects:clinical trial registration,data sharing,and result reporting.The registration rate for AI clinical trials is very low,with even fewer qualified trial registrations.Although there are some platforms for sharing clinical trial data and codes,the public access to the original data and codes of most AI clinical researches is limited.The transparency and completeness of Al clinical trial reports need to be improved,and there is a poor compliance with reporting guidelines.It is hoped that by strengthening data protection,constructing responsibility regulatory frameworks and systems,enhancing the education and training of researchers,and establishing a unified data sharing platform,the transparency of AI clinical trials can be further enhanced,promoting the clinical application of artificial intelligence.

artificial intelligenceclinical trialtransparencymedical ethics

雷芳、杜亮、董敏、刘雪梅

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四川大学华西医院华西期刊社 四川成都 610041

四川大学华西医院华西人工智能医疗器械临床试验中心 四川成都 610041

四川大学华西医院医疗器械监管研究与评价中心 四川成都 610041

四川大学华西医院中国循证医学中心 四川成都 610041

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人工智能 临床试验 透明化 医学伦理

2020年国家自然科学基金项目

72074161

2024

医学与哲学
中国自然辩证法研究会

医学与哲学

CSTPCDCHSSCD北大核心
影响因子:1.314
ISSN:1002-0772
年,卷(期):2024.45(18)
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