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A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection

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  • D. Magirr
  • T. Jaki
  • J. Whitehead

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. Copyright 2012, Oxford University Press.

Suggested Citation

  • D. Magirr & T. Jaki & J. Whitehead, 2012. "A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection," Biometrika, Biometrika Trust, vol. 99(2), pages 494-501.
    • Handle: RePEc:oup:biomet:v:99:y:2012:i:2:p:494-501
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    File URL: http://hdl.handle.net/10.1093/biomet/ass002
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    Cited by:

    1. Jonathan Legare & Ping Yao & Victor S. Y. Lo, 2023. "A case for conducting business-to-business experiments with multi-arm multi-stage adaptive designs," Journal of Marketing Analytics, Palgrave Macmillan, vol. 11(3), pages 490-502, September.
    2. Yan‐Cheng Chao & Thomas M. Braun & Roy N. Tamura & Kelley M. Kidwell, 2020. "A Bayesian group sequential small n sequential multiple‐assignment randomized trial," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 69(3), pages 663-680, June.
    3. Pranab Ghosh & Lingyun Liu & P. Senchaudhuri & Ping Gao & Cyrus Mehta, 2017. "Design and monitoring of multi‐arm multi‐stage clinical trials," Biometrics, The International Biometric Society, vol. 73(4), pages 1289-1299, December.
    4. Pavel Mozgunov & Thomas Jaki, 2020. "An information theoretic approach for selecting arms in clinical trials," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 82(5), pages 1223-1247, December.
    5. Nigel Stallard & Peter K Kimani, 2018. "Uniformly minimum variance conditionally unbiased estimation in multi-arm multi-stage clinical trials," Biometrika, Biometrika Trust, vol. 105(2), pages 495-501.

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