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Methods for identification and confirmation of targeted subgroups in clinical trials : a systematic review
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Ondra, Thomas, Dmitrienko, Alex, Friede, Tim, Graf, Alexandra, Miller, F. (Frank), Stallard, Nigel and Posch, Martin (2016) Methods for identification and confirmation of targeted subgroups in clinical trials : a systematic review. Journal of Biopharmaceutical Statistics, 26 (1). pp. 99-119.
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Official URL: http://www.tandfonline.com/toc/lbps20/current
Abstract
Important objectives in the development of stratified medicines include the identification and confirmation of subgroups of patients with a beneficial treatment effect and a positive benefit-risk balance. We report the results of literature review on methodological approaches to the design and analysis clinical trials investigating a potential heterogeneity of treatment effects across subgroups. The identified approaches are classified based on certain characteristics of the proposed trial designs and analysis methods. We distinguish between exploratory and confirmatory subgroup analysis, frequentist, Bayesian and decision-theoretic approaches and, lastly, fixed-sample, group-sequential and adaptive designs and illustrate the available trial designs and analysis strategies with published case studies.
| Item Type: | Journal Article | ||||||||
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| Subjects: | R Medicine > RA Public aspects of medicine | ||||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Clinical trials -- Methodology | ||||||||
| Journal or Publication Title: | Journal of Biopharmaceutical Statistics | ||||||||
| Publisher: | Taylor & Francis Inc. | ||||||||
| ISSN: | 1054-3406 | ||||||||
| Official Date: | 2016 | ||||||||
| Dates: |
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| Volume: | 26 | ||||||||
| Number: | 1 | ||||||||
| Number of Pages: | 54 | ||||||||
| Page Range: | pp. 99-119 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Restricted or Subscription Access |
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