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Activity Number: 406
Type: Topic Contributed
Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #316280 View Presentation
Title: The Application of Group Sequential Stopping Boundaries to Evaluate the Effect of an Experimental Agent Across a Range of Marker Expression
Author(s): Eric Holmgren*
Companies: Oncomed
Keywords: Biomarker ; Group Sequential ; Phase 2 ; Clinical Development
Abstract:

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

Authors who are presenting talks have a * after their name.

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