A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks

A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design... IntroductionGatekeeping procedures for testing multiple hierarchical objectives such as tests on multiple endpoints have been been studied by many authors in the last 15 years, see, for example, Dmitrienko and Tamhane (, ). For the most part, these studies are restricted to fixed sample designs. However, group sequential designs (GSDs) have become increasingly more common in clinical trials since the early works of Pocock () and O'Brien and Fleming (); Jennison and Turnbull () have given a thorough overview of the subject. Jennison and Turnbull (), Tang and Geller (), and Maurer and Bretz () have addressed certain aspects of multiple testing in GSDs. Still, there is a pressing need to develop procedures at the interface of gatekeeping and group sequential designs. This article addresses a practically important problem at this interface.Hung et al. () were the first to study a gatekeeping test on a primary and a secondary endpoint using a GSD with two looks (or stages). They showed that the fixed‐sequence testing strategy of propagating α from a rejected hypothesis to an unrejected one, used effectively in gatekeeping and graphical procedures (Bretz et al., ), inflates the type I error rate when used in a GSD. Glimm http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Biometrics Wiley

A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks

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Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
© 2018, The International Biometric Society
ISSN
0006-341X
eISSN
1541-0420
D.O.I.
10.1111/biom.12732
Publisher site
See Article on Publisher Site

Abstract

IntroductionGatekeeping procedures for testing multiple hierarchical objectives such as tests on multiple endpoints have been been studied by many authors in the last 15 years, see, for example, Dmitrienko and Tamhane (, ). For the most part, these studies are restricted to fixed sample designs. However, group sequential designs (GSDs) have become increasingly more common in clinical trials since the early works of Pocock () and O'Brien and Fleming (); Jennison and Turnbull () have given a thorough overview of the subject. Jennison and Turnbull (), Tang and Geller (), and Maurer and Bretz () have addressed certain aspects of multiple testing in GSDs. Still, there is a pressing need to develop procedures at the interface of gatekeeping and group sequential designs. This article addresses a practically important problem at this interface.Hung et al. () were the first to study a gatekeeping test on a primary and a secondary endpoint using a GSD with two looks (or stages). They showed that the fixed‐sequence testing strategy of propagating α from a rejected hypothesis to an unrejected one, used effectively in gatekeeping and graphical procedures (Bretz et al., ), inflates the type I error rate when used in a GSD. Glimm

Journal

BiometricsWiley

Published: Jan 1, 2018

Keywords: ; ; ; ; ; ; ; ;

References

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