Sample size calculation for complex clinical trials with survival endpoints

被引：64

作者：

Shih, JH

机构：

[1] Office of Biostatistics Research, National Heart, Lung, Blood Institute, Bethesda, MD

来源：

CONTROLLED CLINICAL TRIALS | 1995年 / 16卷 / 06期

关键词：

Markov model; time-dependent rates; nonproportional hazards; lag time; unconditional power;

D O I：

10.1016/S0197-2456(95)00132-8

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页码：395 / 407

页数：13

共 8 条

[1] SAMPLE SIZES FOR MEDICAL TRIALS WITH SPECIAL REFERENCE TO LONG-TERM THERAPY [J].