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PubMed · 17054103

Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives.

Alex Dmitrienko·Brian L Wiens·Ajit C Tamhane·Xin Wang
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Abstract

This paper discusses a new class of multiple testing procedures, tree-structured gatekeeping procedures, with clinical trial applications. These procedures arise in clinical trials with hierarchically ordered multiple objectives, for example, in the context of multiple dose-control tests with logical restrictions or analysis of multiple endpoints. The proposed approach is based on the principle of closed testing and generalizes the serial and parallel gatekeeping approaches developed by Westfall and Krishen (J. Statist. Planning Infer. 2001; 99:25-41) and Dmitrienko et al. (Statist. Med. 2003; 22:2387-2400). The proposed testing methodology is illustrated using a clinical trial with multiple endpoints (primary, secondary and tertiary) and multiple objectives (superiority and non-inferiority testing) as well as a dose-finding trial with multiple endpoints.

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Antihypertensive AgentsBlood GlucoseBlood PressureBlood Pressure Monitoring, AmbulatoryCholesterol, HDLClinical Trials as TopicData Interpretation, StatisticalDecision TreesDiabetes Mellitus, Type 2Glycated HemoglobinHumansHypertensionHypoglycemic AgentsResearch DesignJournal ArticleResearch Support, N.I.H., Extramural

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Alex Dmitrienko, Brian L Wiens, Ajit C Tamhane, Xin Wang. 2007-05-30. Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives.. https://doi.org/10.1002/sim.2716

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