Sample size calculation for complex clinical trials with survival endpoints
Sample size calculation for complex clinical trials with survival endpoints
复制标题
DOI：
10.1016/s0197-2456(95)00132-8
复制
发表时间：
1995-12-01
期刊：
影响因子：
--
通讯作者：
Shih, JH
中科院分区：
文献类型：
--
作者：
Shih, JH
样本量估计在临床试验计划中很重要。本文的目的是描述的特点和使用的大小，一个全面的计算机程序，用于计算样本量，功率和研究的临床试验中的时间依赖性的事件，交叉和失访率的持续时间。SIZE涵盖了临床试验中常见的各种复杂性，如非比例风险、治疗效果的滞后和治疗获益的不确定性。通过几个假设的例子以及应用到真实的研究设计中来说明SIZE的使用，每个例子都有一个统计问题。
Sample size estimation is important in planning clinical trials. The purpose of this paper is to describe features and use of SIZE, a comprehensive computer program for calculating sample size, power, and duration of study in clinical trials with time-dependent rates of event, crossover, and loss to follow-up. SIZE covers a wide range of complexities commonly occurring in clinical trials, such as nonproportional hazards, lag in treatment effect, and uncertainties in treatment benefit. The use of SIZE is illustrated by several hypothetical examples as well as applications to real study designs, each featuring a statistical issue.