山东医药2025，Vol.65Issue(5)：153-158,6.DOI:10.3969/j.issn.1002-266X.2025.05.032
Ⅰ/Ⅱ期新药研发中适应性无缝设计贝叶斯模型的类型及应用
Bayesian models and application of adaptive seamless designs for phase Ⅰ/Ⅱ new drug development
摘要
Abstract
Adaptive seamless design is an innovative design methodology that integrates independent phase Ⅰ(safety/dose exploration)and phase Ⅱ(efficacy/dose selection)clinical trials into a single consecutive trial in traditional drug dis-covery and development.It improves the efficiency and safety of clinical trials by incorporating Bayesian modeling.There are various Bayesian models in the adaptive seamless designs,which mainly include Bayesian Adaptive Method,Bayesian dose-response model,Bayesian Marginal Probability Model,and Hierarchical Model.With the increasing popularity of Bayesian models in the clinical trials,their application in adaptive seamless designs has become increasingly widespread,particularly in emergency contexts such as cancer immunotherapy,combination therapies,and outbreaks of acute infec-tious diseases.关键词
贝叶斯模型/适应性无缝设计/新药研发/Ⅰ期临床试验/Ⅱ期临床试验Key words
Bayesian model/adaptive seamless design/new drug development/Ⅰ clinical trial/Ⅱ clinical trial分类
药学引用本文复制引用
许颖俭,韩雪,朱鑫伟,刘裕,顾菁,赖颖斯,帅雨杏,陈新林..Ⅰ/Ⅱ期新药研发中适应性无缝设计贝叶斯模型的类型及应用[J].山东医药,2025,65(5):153-158,6.基金项目
国家重点研发计划项目(2023YFC3503002) （2023YFC3503002）
广东省基础与应用基础研究基金项目(2022A1515220162) （2022A1515220162）
广东省广州市科技计划项目(2024B03J1293). （2024B03J1293）
