Minimizing the Maximum Expected Sample Size in Two-Stage Phase II Clinical Trials with Continuous Outcomes

Wason, James M. S. and Mander, Adrian P. ORCID: https://orcid.org/0000-0002-0742-9040 2012. Minimizing the Maximum Expected Sample Size in Two-Stage Phase II Clinical Trials with Continuous Outcomes. Journal of Biopharmaceutical Statistics 22 (4) , pp. 836-852. 10.1080/10543406.2010.528104

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Abstract

Two-stage designs are commonly used for Phase II trials. Optimal two-stage designs have the lowest expected sample size for a specific treatment effect, for example, the null value, but can perform poorly if the true treatment effect differs. Here we introduce a design for continuous treatment responses that minimizes the maximum expected sample size across all possible treatment effects. The proposed design performs well for a wider range of treatment effects and so is useful for Phase II trials. We compare the design to a previously used optimal design and show it has superior expected sample size properties.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Publisher:	Taylor & Francis: STM, Behavioural Science and Public Health Titles
ISSN:	1054-3406
Date of Acceptance:	10 September 2010
Last Modified:	04 Nov 2022 12:29
URI:	https://orca.cardiff.ac.uk/id/eprint/123291

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