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A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information
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Stallard, Nigel (2010) A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information. Statistics in Medicine, Vol.29 (No.9). pp. 959-971. doi:10.1002/sim.3863
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Official URL: http://dx.doi.org/10.1002/sim.3863
Abstract
Seamless phase II/III designs allow strong control of the familywise type I error rate when the most promising of a number of experimental treatments is selected at an interim analysis to continue along with the control treatment. If the primary endpoint is observed only after long-term follow-up it may be desirable to use correlated short-term endpoint data available at the interim analysis to inform the treatment selection. If short-term data are available for some patients for whom the primary endpoint is not available, basing treatment selection on these data may, however, lead to inflation of the type I error rate. This paper proposes a method for the adjustment of the usual group-sequential boundaries to maintain strong control of the familywise error rate even when short-term endpoint data are used for the treatment selection at the first interim analysis. This method allows the use of the short-term data, leading to an increase in power when these data are correlated with the primary endpoint data. Copyright (C) 2010 John Wiley & Sons, Ltd.
| 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 Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Clinical trials -- Design, Clinical trials -- Statistical methods, Therapeutics -- Testing | ||||
| Journal or Publication Title: | Statistics in Medicine | ||||
| Publisher: | John Wiley & Sons Ltd. | ||||
| ISSN: | 0277-6715 | ||||
| Official Date: | 30 April 2010 | ||||
| Dates: |
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| Volume: | Vol.29 | ||||
| Number: | No.9 | ||||
| Number of Pages: | 13 | ||||
| Page Range: | pp. 959-971 | ||||
| DOI: | 10.1002/sim.3863 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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