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

TitleFlexible stopping boundaries when changing primary endpoints after unblinded interim analyses.
Publication TypeJournal Article
Year of Publication2014
AuthorsChen, Liddy M., Joseph G. Ibrahim, and Haitao Chu
JournalJ Biopharm Stat
Volume24
Issue4
Pagination817-33
Date Published2014
ISSN1520-5711
KeywordsClinical Trials as Topic, Endpoint Determination, Humans, Research Design
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.

DOI10.1080/10543406.2014.901341
Alternate JournalJ Biopharm Stat
Original PublicationFlexible stopping boundaries when changing primary endpoints after unblinded interim analyses.
PubMed ID24697500
PubMed Central IDPMC4024106
Grant ListP01 ES014635 / ES / NIEHS NIH HHS / United States
1P01CA142538 / CA / NCI NIH HHS / United States
U54-MD008620 / MD / NIMHD NIH HHS / United States
2P30CA077598 / CA / NCI NIH HHS / United States
P01 CA142538 / CA / NCI NIH HHS / United States
Project: