随机自适应设计的统计模拟  

Statistical Simulation of Response-adaptive Design

作　　者：言方荣[1] 黄园[1] 

机构地区：[1]中国药科大学基础部数学教研室,南京210009

出　　处：《数理医药学杂志》2011年第5期520-523,共4页Journal of Mathematical Medicine

摘　　要：自适应设计是允许在不破坏试验有效性与安全性的前提下,通过临床中期分析,来发现和更改试验设计之初不合理的假设,降低研发成本,缩短研究周期。本研究借助matlab软件及蒙特卡罗方法,模拟优效性试验中两个治疗组(试验组与控制组)主要终点治疗指标的变化,包括组间差异值,方差,分配比,变异系数及样本容量的取值变化,观察对检验功效的影响。并通过模拟确定临床Ⅱ期实验中所需的最低样本容量。Response-adaptive design is a trial design that allows modifications to some aspects of the trial after its initiation without undermining the validity and integrity of the trial,and makes it possible to discover and rectify inappropriate assumptions in trial designs,lower development costs and reduce the time to market.It has become very attractive to the pharmaceutical industries.In this paper,relationship between power and variables exits in response-adaptive design will be studied by using the Monte Carlo Simulation（MCS）.MCS provides a unique and powerful tool to achieve the optimal design.Then the required sample size under the specified power will be determined.

关 键 词：自适应设计 检验功效 蒙特卡罗模拟 最低样本容量 

分 类 号：R311[医药卫生—基础医学]