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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

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Official URL: http://dx.doi.org/10.1080/10543406.2013.840646

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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
Subjects: Q Science > QA Mathematics
R Medicine > R Medicine (General)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Journal or Publication Title: Journal of Biopharmaceutical Statistics
Publisher: Taylor & Francis Inc.
ISSN: 1054-3406
Official Date: 20 January 2015
Dates:
DateEvent
20 January 2015Published
3 April 2014Available
17 August 2013Accepted
18 September 2012Submitted
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
Funder: Medical Research Council
Grant number: G1001344

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