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<p>Artificial intelligence and machine learning are transforming drug development by streamlining clinical trials. This review examines their role in enhancing trial design through parameter optimization and endpoint development, as well as improving trial conduct via optimized site selection, patient recruitment, and safety monitoring. It also details AI/ML applications in data analytics—including adaptive designs (dose finding, randomization), data cleaning, synthetic control generation, and multimodal data integration—as well as predicting trial success and enrollment. The paper concludes by emphasizing the necessity of robust technical validation, ethical oversight, and regulatory alignment for the safe and effective integration of these technologies.</p>

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Transformative Roles of Artificial Intelligence in Clinical Trials

  • 期刊论文

  • 发表日期：

    2026年3月31日

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  • Jie Chen

摘要

Artificial intelligence and machine learning are transforming drug development by streamlining clinical trials. This review examines their role in enhancing trial design through parameter optimization and endpoint development, as well as improving trial conduct via optimized site selection, patient recruitment, and safety monitoring. It also details AI/ML applications in data analytics—including adaptive designs (dose finding, randomization), data cleaning, synthetic control generation, and multimodal data integration—as well as predicting trial success and enrollment. The paper concludes by emphasizing the necessity of robust technical validation, ethical oversight, and regulatory alignment for the safe and effective integration of these technologies.