I期临床试验设计比较  

Comparison of Phase I Clinical Trials

作　　者：李萌 张洵 

机构地区：[1]长沙理工大学,数学与统计学院,湖南 长沙

出　　处：《应用数学进展》2023年第12期5120-5126,共7页Advances in Applied Mathematics

摘　　要：I期临床可以分为基于规则、基于模型和基于模型辅助三种。选取上述三种设计具有代表性的设计,分别为3 + 3、CRM和BOIN,进行准确性和安全性评价。首先回顾三种设计的规则,区分三种规则之间的差异性;其次利用蒙特卡洛进行模拟,通过数值结果比较设计的准确性与安全性;最后对三种设计进行讨论。Phase I Clinical Trials can be divided into rule-based, model-based and model-assisted design three types. Select the above three representative designs, namely 3 + 3, CRM and BOIN, to evaluate the accuracy and safety. Firstly, review the three design rules and distinguish the differences among them. Secondly, Monte Carlo simulation is used to compare the accuracy and safety of the design through numerical results. Finally, three designs are discussed.

关 键 词：3 + 3 持续再评估方法 贝叶斯最优区间设计 

分 类 号：TP3[自动化与计算机技术—计算机科学与技术]