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

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 AI 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.