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Dose selection in seamless phase II/III clinical trials based on efficacy and safety
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Kimani, Peter K., Stallard, Nigel and Hutton, Jane (2009) Dose selection in seamless phase II/III clinical trials based on efficacy and safety. Statistics in Medicine, Vol.28 (No.6). pp. 917-936. doi:10.1002/sim.3522
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Official URL: http://dx.doi.org/10.1002/sim.3522
Abstract
Seamless phase II/III clinical trials are attractive in development of new drugs because they accelerate the drug development process. Seamless phase II/III trials are carried out in two stages. After stage I (phase II stage), an interim analysis is performed and a decision is made on whether to proceed to stage 2 (phase III stage). If the decision is to continue with further testing, some dose-selection procedure is used to determine the set of doses to be tested in stage 2. In this paper, we propose a dose-selection procedure for binary outcomes in adaptive seamless phase II/III clinical trials that incorporates the dose-response relationship when the experimental treatments are different dose levels of the same drug, and explicitly incorporates both efficacy and safety. The choice of the doses to continue to stage 2 is made by comparing the predictive power of the potential sets of doses, which might continue. Copyright (C) 2009 John Wiley & Sons, Ltd.
| Item Type: | Journal Article | ||||
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| Subjects: | Q Science > QA Mathematics R Medicine R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Science > Statistics Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Medicine -- Statistics, Clinical trials, Clinical trials -- Methodology, Drug development, Drugs -- Effectiveness -- Research | ||||
| Journal or Publication Title: | Statistics in Medicine | ||||
| Publisher: | John Wiley & Sons Ltd. | ||||
| ISSN: | 0277-6715 | ||||
| Official Date: | 15 March 2009 | ||||
| Dates: |
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| Volume: | Vol.28 | ||||
| Number: | No.6 | ||||
| Number of Pages: | 20 | ||||
| Page Range: | pp. 917-936 | ||||
| DOI: | 10.1002/sim.3522 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access | ||||
| Funder: | University of Warwick |
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