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A comparison of methods for adaptive treatment selection
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Friede, Tim and Stallard, Nigel (2008) A comparison of methods for adaptive treatment selection. Biometrical Journal, Vol.50 (No.5 Sp. Iss. SI). pp. 767-781. doi:10.1002/bimj.200710453 ISSN 0323-3847.
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Official URL: http://dx.doi.org/10.1002/bimj.200710453
Abstract
Traditionally drug development is generally divided into three phases which have different aims and objectives. Recently so-called adaptive seamless designs that allow combination of the objectives of different development phases into a single trial have gained much interest. Adaptive trials combining treatment selection typical for Phase II and confirmation of efficacy as in Phase III are referred to as adaptive seamless Phase II/III designs and are considered in this paper. We compared four methods for adaptive treatment selection, namely the classical Dunnett test, an adaptive version of the Dunnett test based on the conditional error approach, the combination test approach, and an approach within the classical group-sequential framework. The latter two approaches have only recently been published. In a simulation study we found that no one method dominates the others in terms of power apart from the adaptive Dunnett test that dominates the classical Dunnett by construction. Furthermore, scenarios under which one approach outperforms others are described.
Item Type: | Journal Article | ||||
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Subjects: | Q Science > QA Mathematics R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||
Library of Congress Subject Headings (LCSH): | Clinical trials -- Design, Experimental design, Therapeutics -- Testing | ||||
Journal or Publication Title: | Biometrical Journal | ||||
Publisher: | Wiley - V C H Verlag GmbH & Co. KGaA | ||||
ISSN: | 0323-3847 | ||||
Official Date: | October 2008 | ||||
Dates: |
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Volume: | Vol.50 | ||||
Number: | No.5 Sp. Iss. SI | ||||
Number of Pages: | 15 | ||||
Page Range: | pp. 767-781 | ||||
DOI: | 10.1002/bimj.200710453 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access | ||||
Version or Related Resource: | Paper presented at the 5th International Conference on Multiple Comparison Procedures (MCP 2007), Vienna, Austria 9–11 July, 2007. |
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