A variation of a 2-in-1 adaptive design to seamlessly expand a selected dose from a phase 2 trial to a phase 3 trial for oncology drug development.

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第一作者： Pingye,Zhang

第一单位： Global Statistics and Data Science, BeiGene, Ltd., Ridgefield Park, NJ, USA. Electronic address: pingyezhangusc@gmail.com.

作者： Pingye,Zhang ^[1] ; Xiaoyun Nicole,Li ^[2] ; Kaifeng,Lu ^[2] ; Chengqing,Wu ^[2] ; Miaomiao,Ge ^[3]

作者单位： Global Statistics and Data Science, BeiGene, Ltd., Ridgefield Park, NJ, USA. Electronic address: pingyezhangusc@gmail.com. ^[1] Global Statistics and Data Science, BeiGene, Ltd., Ridgefield Park, NJ, USA. ^[2] Department of Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc, 900 Ridgebury Road, Ridgefield, CT 06877, USA. ^[3]

关键词 2-in-1 adaptive design Dose optimization, seamless phase 2/3 trial Oncology

主题词人类(Humans);研究设计(Research Design);医学肿瘤学(Medical Oncology);剂量效应关系, 药物(Dose-Response Relationship, Drug)

DOI 10.1016/j.cct.2023.107119

PMID 36804045

发布时间 2023-04-14

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准确一般字义偏差语意偏离译文作用小提交