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A conditional error function approach for subgroup selection in adaptive clinical trials
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Friede, Tim, Parsons, Nicholas R. and Stallard, Nigel (2012) A conditional error function approach for subgroup selection in adaptive clinical trials. Statistics in Medicine, Vol.31 (No.30). pp. 4309-4320. doi:10.1002/sim.5541 ISSN 0277-6715.
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Official URL: http://dx.doi.org/10.1002/sim.5541
Abstract
Growing interest in personalised medicine and targeted therapies is leading to an increase in the importance of subgroup analyses. If it is planned to view treatment comparisons in both a predefined subgroup and the full population as co-primary analyses, it is important that the statistical analysis controls the familywise type I error rate. Spiessens and Debois (Cont. Clin. Trials, 2010, 31, 647–656) recently proposed an approach specific for this setting, which incorporates an assumption about the correlation based on the known sizes of the different groups, and showed that this is more powerful than generic multiple comparisons procedures such as the Bonferroni correction. If recruitment is slow relative to the length of time taken to observe the outcome, it may be efficient to conduct an interim analysis. In this paper, we propose a new method for an adaptive clinical trial with co-primary analyses in a predefined subgroup and the full population based on the conditional error function principle. The methodology is generic in that we assume test statistics can be taken to be normally distributed rather than making any specific distributional assumptions about individual patient data. In a simulation study, we demonstrate that the new method is more powerful than previously suggested analysis strategies. Furthermore, we show how the method can be extended to situations when the selection is not based on the final but on an early outcome. We use a case study in a targeted therapy in oncology to illustrate the use of the proposed methodology with non-normal outcomes. Copyright © 2012 John Wiley & Sons, Ltd.
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: | Statistics in Medicine | ||||
Publisher: | John Wiley & Sons Ltd. | ||||
ISSN: | 0277-6715 | ||||
Official Date: | 2012 | ||||
Dates: |
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Volume: | Vol.31 | ||||
Number: | No.30 | ||||
Page Range: | pp. 4309-4320 | ||||
DOI: | 10.1002/sim.5541 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access | ||||
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