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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, Cornelia, Friede, Tim, Parsons, Nicholas R., Todd, Susan and Stallard, Nigel (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. doi:10.1080/10543406.2013.840646 ISSN 1054-3406.
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Official URL: http://dx.doi.org/10.1080/10543406.2013.840646
Abstract
In an adaptive seamless phase II/III clinical trial interim
analysis data are used for treatment selection, enabling resources to be focussed 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 focusses 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-term and long-term endpoints.
Item Type: | Journal Article | ||||||||||
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Subjects: | Q Science > QA Mathematics R Medicine > R Medicine (General) |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Journal of Biopharmaceutical Statistics | ||||||||||
Publisher: | Taylor & Francis Inc. | ||||||||||
ISSN: | 1054-3406 | ||||||||||
Official Date: | 20 January 2015 | ||||||||||
Dates: |
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Volume: | 25 | ||||||||||
Number: | 1 | ||||||||||
Page Range: | pp. 170-189 | ||||||||||
DOI: | 10.1080/10543406.2013.840646 | ||||||||||
Status: | Peer Reviewed | ||||||||||
Publication Status: | Published | ||||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||||
Date of first compliant deposit: | 25 December 2015 | ||||||||||
Date of first compliant Open Access: | 25 December 2015 | ||||||||||
Funder: | Medical Research Council | ||||||||||
Grant number: | G1001344 |
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