Abstract: The application of artificial intelligence (AI) technology in drug clinical trials has becoming increasingly widespread, significantly improving trial efficiency. This is mainly evident in areas such as patient recruitment and stratification, trial design optimization, data processing and analysis, and pharmacovigilance and safety monitoring. However, the application faces challenges in the areas of data standardization and quality, technical reliability and security, ethical and legal responsibilities, as well as regulatory and compliance aspects. To address these challenges, it is necessary to establish unified data standards, improve technical evaluation systems, strengthen ethical review, and promote international regulatory coordination. These efforts aim to strike a balance between innovative development and risk control and to lay a foundation for the standardized application of AI technology in drug development. This review summarizes the progress and challenges of AI technology in drug clinical trials.