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

Research output: Contribution to journalJournal article

Published

Journal publication date06/2012
JournalBiometrika
Journal number2
Volume99
Number of pages8
Pages494-501
Original languageEnglish

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.