摘要
选择合适的方法探索药物的最大耐受剂量(MTD)一直是Ⅰ期耐受性试验设计的要点。贝叶斯最优区间(BOIN)设计是一种新颖的确定MTD的模型辅助设计,兼顾规则设计的简单性及模型设计的良好特性,具有可操作性强、安全性高、识别MTD准确性高、灵活高效等优点。本研究模拟临床试验,采用BOIN设计进行操作说明。
To select the appropriate method to explore the maximum tolerated dose(MTD)of drugs has been the main point of the design of phaseⅠtolerance trials.Bayesian optimal interval(BOIN)design is a novel model-assisted design for determining MTD,which combines the simplicity of rule-design with the good characteristics of model-design,with the advantages of strong operability,high security,high accuracy of MTD identification,flexibility and efficiency.This study simulates clinical trial using BOIN design to explain the operation procedures.
作者
沈庆
孙瑞华
郝肖迪
虞康达
吴婉玲
肖畅
王蜜源
SHEN Qing;SUN Rui-hua;HAO Xiao-di;YU Kang-da;WU Wan-ling;XIAO Chang;WANG Mi-yuan(School of Management,Beijing University of Chinese Medicine,BEIJING 100029,China;Clinical Research Data and Project Management Platform,China-Japan Friendship Hospital,BEIJING 100029,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2019年第9期533-536,共4页
Chinese Journal of New Drugs and Clinical Remedies
