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Innovation in the design and technique use of drug clinical trial

Hai-yan XIONG, Jian-feng LUO, Wei-bing WANG

Fudan University Journal of Medical Sciences, 2025, 52(01): 153-158. DOI: 10.3969/j.issn.1672-8467.2025.01.022

Fig 1 Diagrams of basket trial and umbrella trial

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Fig 2 The possible application scenarios of AI and machine learning in clinical trials CRF: Case report forms; SDTM: Study data tabulation model; DB: Double blind; SDV: Source data verification; PV: Pharmacovigilance; TMF: Trial master file; CSR: Clinical study report; AI: Artificial intelligence; ML: Machine learning.