机器学习和人工智能在临床试验中的当前应用和未来挑战:范围审查
Ajsi Kanapari1, Giulia Lorenzoni1, Honoria Ocagli1
1Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.
Digital health
|December 8, 2025
概括
机器学习 (ML) 和人工智能 (AI) 应用在临床试验 (CT) 中未得到充分利用,尽管它们有提高效率的潜力. 本综述量化了跨CT阶段的ML/AI使用情况,揭示了潜在和实际实施之间的差距.
科学领域:
- 临床研究 临床研究
- 医疗信息学 医疗信息学
- 数据科学数据科学数据科学
背景情况:
- 机器学习 (ML) 和人工智能 (AI) 在临床研究中越来越多地被使用.
- 它们在临床试验 (CTs) 中的具体应用和量化尚未得到充分研究.
研究的目的:
- 进行范围审查,以量化ML和AI应用在CT设计,进行和分析中的程度.
- 在临床试验过程的各个阶段识别ML/AI的当前利用模式.
主要方法:
- 使用PubMed,Embase和Scopus数据库进行了全面的范围审查.
- 搜索包括临床试验和协议,对Covidence进行查,使用GPT模型支持.
- 在标题/摘要和全文选后,包括了108条记录.
主要成果:
- 在多个CT阶段确定了ML/AI应用,其中93个CT主要在数据分析中使用这些技术.
- 具体的设计应用包括先进的方法 (20项研究),分层 (6),治疗选择 (4),参与者选择 (6),结果评估 (2) 和地点选择 (2).
- 在七项研究中,可穿戴设备数据收集和分析涉及ML/AI,其中一项研究用于监测.
结论:
- 在CT中ML/AI的潜在好处与其当前的实际应用之间存在很大的差异.
- 在CT中ML/AI的不足利用可能会阻碍开发更快,更有效的临床试验方法.
- 需要进一步的研究和标准化的报告来充分利用ML/AI来推进临床试验.
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