Sample size estimation in phase III cancer clinical trials

被引：17

作者：

Curran, D

Sylvester, RJ

Boes, GH

机构：

[1] Eortc Data Ctr, B-1200 Brussels, Belgium

[2] Zeneca Pharmaceut, Macclesfield, Cheshire, England

来源：

EUROPEAN JOURNAL OF SURGICAL ONCOLOGY | 1999年 / 25卷 / 03期

关键词：

endpoint; factorial design; equivalence trials; variance; Type I and Type III errors;

D O I：

10.1053/ejso.1998.0635

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

This paper deals with the basic principles involved in sample size calculation of phase III cancer clinical trials. It illustrates the concepts and factors determining the sample size. Various examples of phase III cancer clinical trials are provided and the sample size is calculated taking into account the assumptions made. The examples provided include sample sizes for comparing proportions and sample sizes for comparing survival times, Several special topics are also discussed including choice of endpoint, number of treatment groups, factorial designs and equivalence trials.

引用

页码：244 / 250

页数：7

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