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

Kunz, Cornelia Ursula and Friede, Tim and Parsons, Nicholas and 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. ISSN 1054-3406

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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 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.

Item Type:
Journal Article
Journal or Publication Title:
Journal of Biopharmaceutical Statistics
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/2700/2736
Subjects:
?? ADAPTIVE SEAMLESS DESIGNMULTI-ARM MULTI-STAGE TRIALSURROGATE ENDPOINTSSTATISTICS AND PROBABILITYPHARMACOLOGYPHARMACOLOGY (MEDICAL) ??
ID Code:
73892
Deposited By:
Deposited On:
18 Jun 2015 05:55
Refereed?:
Yes
Published?:
Published
Last Modified:
18 Sep 2023 00:52