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A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information.
MedLine Citation:
PMID:  20191605     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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 © 2010 John Wiley & Sons, Ltd.
Authors:
Nigel Stallard
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Publication Detail:
Type:  Journal Article     Date:  2010-02-26
Journal Detail:
Title:  Statistics in medicine     Volume:  29     ISSN:  1097-0258     ISO Abbreviation:  Stat Med     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2011-10-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  959-71     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 John Wiley & Sons, Ltd.
Affiliation:
Warwick Medical School, The University of Warwick, Coventry CV4 7AL, U.K.. n.stallard@warwick.ac.uk.
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