Group sequential designs for Phase II trials with historical controls

被引：10

作者：

Chang, MN ^{[1
]}

Shuster, JJ ^{[1
]}

Kepner, JL ^{[1
]}

机构：

[1] Univ Florida, Dept Stat, Gainesville, FL 32601 USA

来源：

CONTROLLED CLINICAL TRIALS | 1999年 / 20卷 / 04期

关键词：

clinical trials; group sequential tests; historical controls; Phase II trials; two-stage designs;

D O I：

10.1016/S0197-2456(99)00008-2

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：

Two-step tests based on historical control data are proposed for detecting different means when experimental and control populations are normally distributed with possibly different known variances. The results readily extend to the case where the control and experimental data are dichotomous. Provisions for early acceptance and early rejection are included. Control Clin Trials 1999;20:353-364 (C) Elsevier Science Inc. 1999.

引用

页码：353 / 364

页数：12

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