临床试验中的人工智能:对机遇,挑战和未来方向的全面审查
David B Olawade1, Sandra Chinaza Fidelis2, Sheila Marinze3
1Department of Research and Innovation, Medway NHS Foundation Trust, Gillingham ME7 5NY, United Kingdom; Department of Public Health, York St John University, London, United Kingdom; Department of Allied and Public Health, School of Health, Sport and Bioscience, University of East London, London, United Kingdom.
International journal of medical informatics
|October 11, 2025
概括
人工智能 (AI) 显著提高了临床试验的效率,促进了招聘并降低了成本. 解决数据偏差和监管障碍等实施挑战对于实现AI在医学研究中的全部潜力至关重要.
科学领域:
- 临床研究 临床研究
- 人工智能的人工智能
- 医疗信息学 医疗信息学
背景情况:
- 临床试验面临重大挑战:80%的招聘延迟,研发成本每年超过2000亿美元,成功率低于12%,50%的数据集存在质量问题.
- 人工智能 (AI) 提出了变革性的解决方案,以解决整个临床试验生命周期中的低效率问题.
研究的目的:
- 评估AI在临床试验中的当前状态和未来潜力.
- 评估人工智能实施挑战,为负责任的整合提供指导.
- 在人工智能驱动的临床研究中确保患者安全和科学完整性.
主要方法:
- 进行了对文学进行全面的叙事审查.
- 从2015年1月到2024年12月进行了主要数据库 (PubMed,Embase,IEEE Xplore,Google Scholar) 的系统搜索.
- 根据临床试验生命周期阶段主题综合提取的数据.
主要成果:
- 人工智能工具提高了65%的患者招募率,预测模型达到85%的准确性.
- 人工智能集成加速了30-50%的试验时间表,并降低了高达40%的成本.
- 数字生物标志物显示不良事件检测的灵敏度为90%,尽管数据互操作性和监管不确定性等障碍仍然存在.
结论:
- 人工智能是一个变革性的力量,提高临床研究的效率,成本效益和患者的结果.
- 实现人工智能的潜力需要解决基础设施,可解释性和监管框架.
- 合作努力对于在临床试验中负责任地实施AI至关重要.
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