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Stage phase II clinical trials with continuous outcomes

Lookup NU author(s): Professor James WasonORCiD

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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. Copyright © Taylor & Francis Group, LLC.

Publication metadata

Author(s): Wason JMS, Mander AP

Publication type: Article

Publication status: Published

Journal: Journal of Biopharmaceutical Statistics

Year: 2012

Volume: 22

Issue: 4

Pages: 836-852

Online publication date: 31/05/2012

ISSN (print): 1054-3406

ISSN (electronic): 1520-5711

Publisher: Taylor and Francis

URL: https://doi.org/10.1080/10543406.2010.528104

DOI: 10.1080/10543406.2010.528104

PubMed id: 22651118

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