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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

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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
Subjects: Q Science > QA Mathematics
R Medicine > R Medicine (General)
R Medicine > RM Therapeutics. Pharmacology
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
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:
DateEvent
30 April 2010Published
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

Data sourced from Thomson Reuters' Web of Knowledge

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