A modification of Simon's optimal design for phase II trials when the criterion is median sample size

被引：22

作者：

Hanfelt, JJ

Slack, RS

Gehan, EA

机构：

[1] Emory Univ, Rollins Sch Publ Hlth, Dept Biostat, Atlanta, GA 30322 USA

[2] Georgetown Univ, Lombardi Canc Ctr, Washington, DC USA

[3] Georgetown Univ, Dept Biomath & Biostat, Washington, DC USA

来源：

CONTROLLED CLINICAL TRIALS | 1999年 / 20卷 / 06期

关键词：

clinical trials; multistage study design;

D O I：

10.1016/S0197-2456(99)00028-8

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 [基础医学];

摘要：

We present a modification to Simon's optimal design for phase II trials in which the objective is to minimize the median sample size rather than the expected sample size when the true response rate is poor (p = p(0)). We argue that the modified design may be preferred in smaller institutions when the focus is on a single or small number of phase II trials rather than a large program of phase II trials. (C) Elsevier Science Inc. 1999.

引用

页码：555 / 566

页数：12

共 9 条

[1]

Chen TT, 1997, STAT MED, V16, P2701, DOI 10.1002/(SICI)1097-0258(19971215)16:23<2701::AID-SIM704>3.0.CO

[2]

2-1

[3]

AN OPTIMAL 3-STAGE DESIGN FOR PHASE-II CLINICAL-TRIALS [J].