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A generalized Dunnett Test for Multi-arm Multi-stage Clinical Studies with Treatment Selection

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Published
<mark>Journal publication date</mark>06/2012
<mark>Journal</mark>Biometrika
Issue number2
Volume99
Number of pages8
Pages (from-to)494-501
Publication StatusPublished
<mark>Original language</mark>English

Abstract

We generalize the Dunnett test to derive efficacy and futility boundaries for a flexible multi-arm multi-stage clinical trial for a normally distributed endpoint with known variance. We show that the boundaries control the familywise error rate in the strong sense. The method is applicable for any number of treatment arms, number of stages and number of patients per treatment per stage. It can be used for a wide variety of boundary types or rules derived from α-spending functions. Additionally, we show how sample size can be computed under a least favourable configuration power requirement and derive formulae for expected sample sizes.