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J Biopharm Stat. 2014;24(4):817-33. doi: 10.1080/10543406.2014.901341.

Flexible stopping boundaries when changing primary endpoints after unblinded interim analyses.

Author information

1
a Global Research Operation, Biostatistics, PAREXEL International , Durham , North Carolina , USA.

Abstract

It has been widely recognized that interim analyses of accumulating data in a clinical trial can inflate type I error. Different methods, from group sequential boundaries to flexible alpha spending functions, have been developed to control the overall type I error at prespecified level. These methods mainly apply to testing the same endpoint in multiple interim analyses. In this article, we consider a group sequential design with preplanned endpoint switching after unblinded interim analyses. We extend the alpha spending function method to group sequential stopping boundaries when the parameters can be different between interim, or between interim and final analyses.

KEYWORDS:

Alpha spending function; Group sequential trials; Interim analyses; Stopping boundaries; Switching endpoints

PMID:
24697500
PMCID:
PMC4024106
DOI:
10.1080/10543406.2014.901341
[Indexed for MEDLINE]
Free PMC Article
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