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Abstract Details
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Activity Number:
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606
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 2, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304954 |
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Title:
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Test and Power Considerations for Multiple Endpoint Analyses
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Author(s):
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Frank Bretz*+ and Willi Maurer and Ekkehard Glimm
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Companies:
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Novartis and Novartis and Novartis
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Address:
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, , , Switzerland
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Keywords:
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Clinical trials ;
multiple testing ;
multiplicity ;
gatekeeping ;
graphical procedure ;
sample size
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Abstract:
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A variety of powerful test procedures are available for the analysis of clinical trials addressing multiple objectives, such as comparing several treatments with a control, assessing the benefit of a new drug for more than one endpoint, etc. Most research has focused on the analysis of such structured multiple hypotheses test problems. In this presentation we focus on the problem of determining the sample size in such situations. We discuss suitable power measures for clinical trials with multiple primary and/or secondary objectives. We discuss the importance of choosing suitable weights for the underlying closed test procedures and how to optimally propagate local significance levels to meet the study objectives. We use a real case study to illustrate the results.
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