A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints

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Kunz, C. U., Friede, T., Parsons, N., Todd, S. orcid id iconORCID: https://orcid.org/0000-0002-9981-923X and Stallard, N. (2015) A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints. Journal of Biopharmaceutical Statistics, 25 (1). pp. 170-189. ISSN 1054-3406 doi: 10.1080/10543406.2013.840646

Abstract/Summary

In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment selection, enabling resources to be focused on comparison of more effective treatment(s) with a control. In this paper, we compare two methods recently proposed to enable use of short-term endpoint data for decision-making at the interim analysis. The comparison focuses on the power and the probability of correctly identifying the most promising treatment. We show that the choice of method depends on how well short-term data predict the best treatment, which may be measured by the correlation between treatment effects on short- and long-term endpoints.

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Item Type Article
URI https://reading-clone.eprints-hosting.org/id/eprint/39111
Identification Number/DOI 10.1080/10543406.2013.840646
Refereed Yes
Divisions Science > School of Mathematical, Physical and Computational Sciences > Department of Mathematics and Statistics
Science > School of Mathematical, Physical and Computational Sciences > Department of Mathematics and Statistics > Applied Statistics
Uncontrolled Keywords Adaptive seamless design, Multi-arm multi-stage trial, Surrogate endpoints
Publisher Taylor & Francis
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