Adaptive Dunnett tests for treatment selection

被引：79

作者：

Koenig, Franz ^{[1
]}

Brannath, Werner ^{[1
]}

Bretz, Frank ^{[2
]}

Posch, Martin ^{[1
]}

机构：

[1] Med Univ Vienna, Core Unit Med Stat & Informat, Sect Med Stat, A-1090 Vienna, Austria

[2] Novartis Pharma AG, CH-4002 Basel, Switzerland

来源：

STATISTICS IN MEDICINE | 2008年 / 27卷 / 10期

关键词：

adaptive seamless design; flexible designs; conditional error rate; clinical trials; many-to-one comparisons;

D O I：

10.1002/sim.3048

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Clinical trials incorporating treatment selection at pre-specified interim analyses allow to integrate two clinical studies into a single, confirmatory study. In an adaptive interim analysis, treatment arms are selected based on interim data as well as external information. The specific selection rule does not need to be pre-specified in advance in order to control the multiple type I error rate. We propose an adaptive Dunnett test procedure based on the conditional error rate of the single-stage Dunnett test. The adaptive procedure uniformly improves the classical Dunnett test, which is shown to be strictly conservative if treatments are dropped at interim. The adaptive Dunnett test is compared in a simulation with the classical Dunnett test as well as with adaptive combination tests based on the closure principle. The method is illustrated with a real-data example. Copyright (C) 2007 John Wiley & Sons, Ltd.

引用

页码：1612 / 1625

页数：14

共 26 条

[11]

Hommel G, 2001, BIOMETRICAL J, V43, P581, DOI 10.1002/1521-4036(200109)43:5<581::AID-BIMJ581>3.0.CO

[12]

2-J

[13] Methodological issues with adaptation of clinical trial design [J].