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Adaptive designs for confirmatory clinical trials with subgroup selection
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Stallard, Nigel, Hamborg, Thomas, Parsons, Nicholas R. and Friede, Tim (2014) Adaptive designs for confirmatory clinical trials with subgroup selection. Journal of Biopharmaceutical Statistics, Volume 24 (Number 1). pp. 168-187. doi:10.1080/10543406.2013.857238 ISSN 1054-3406.
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Official URL: http://dx.doi.org/10.1080/10543406.2013.857238
Abstract
Growing interest in stratified medicine is leading to increasing importance of subgroup analyses in confirmatory clinical trials. Conventionally, confirmatory clinical trials either focus on a subgroup identified in advance or assess subgroup effects once the trial is completed. The focus of this article is methodology for adaptive clinical trials that both identify whether a treatment is particularly effective in a predefined subgroup, potentially enabling alteration of recruitment, and assess the effectiveness in the subgroup and/or whole population. Methods for such adaptive trials are described and compared, and the logistical and regulatory issues associated with such approaches are discussed.
Item Type: | Journal Article | ||||
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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: | 2014 | ||||
Dates: |
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Volume: | Volume 24 | ||||
Number: | Number 1 | ||||
Page Range: | pp. 168-187 | ||||
DOI: | 10.1080/10543406.2013.857238 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
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