Transcription of Gatekeeping procedures with clinical trial applications
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PHARMACEUTICAL STATISTICSP harmaceut. ;6: 171 180 Published online 21 June 2007 in Wiley InterScience( ) DOI: procedures with clinicaltrial applicationsAlex Dmitrienko1,*,yand Ajit C. Tamhane21 Eli Lilly and Company, Indianapolis, IN, USA2 Northwestern University, Evanston, IL, USAThe objective of this paper is to give an overview of a relatively new area of multiplicity research thatdeals with the analysis of hierarchically ordered multiple objectives. Testing procedures for thisproblem are known as Gatekeeping procedures and have found a variety of applications in clinicaltrials. This paper reviews main classes of these procedures , including serial and parallel gatekeepingprocedures, and tree Gatekeeping procedures that account for logical restrictions among multipleobjectives. We focus on procedures based on marginalp-values; extensions to procedures that exploitthe joint distribution of thep-values are also noted.
Gatekeeping procedures are defined as multiple testing procedures that meet the following condi-tions: * Type I error rate control: The familywise error rate (FWER ...
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