Abstract Details
Activity Number:
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406
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #316280
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View Presentation
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Title:
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The Application of Group Sequential Stopping Boundaries to Evaluate the Effect of an Experimental Agent Across a Range of Marker Expression
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Author(s):
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Eric Holmgren*
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Companies:
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Oncomed
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Keywords:
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Biomarker ;
Group Sequential ;
Phase 2 ;
Clinical Development
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Abstract:
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Using stopping boundaries developed for group sequential trials, we control the overall type 1 error for a series of tests that evaluate the treatment effect of an experimental agent in each of several predefined marker subgroups. We then go on to present a procedure based on these group sequential stopping boundaries that provides strong control of type 1 error for testing a series of hypothesis regarding the treatment effect over a range of marker expression. To provide some context for this procedure we will also discuss the role of a biomarker in Phase 2 from the perspective of the Phase 2/3 clinical development of a new molecule
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Authors who are presenting talks have a * after their name.
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