Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - A generalized Dunnett Test for Multi-arm Multi-stage Clinical Studies with Treatment Selection
AU - Magirr, Dominic
AU - Jaki, Thomas
AU - Whitehead, John
PY - 2012/6
Y1 - 2012/6
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Dunnett test
KW - Familywise error rate
KW - Treatment selection
U2 - 10.1093/biomet/ass002
DO - 10.1093/biomet/ass002
M3 - Journal article
VL - 99
SP - 494
EP - 501
JO - Biometrika
JF - Biometrika
SN - 0006-3444
IS - 2
ER -