Abstract Details
Activity Number:
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30
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Type:
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Contributed
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Date/Time:
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Sunday, August 3, 2014 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313246
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View Presentation
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Title:
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An Adaptive Cohort Up-and-Down Design to Identify Doses with a Low Event Rate When the Study Duration Is Fixed
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Author(s):
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David Li*+
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Companies:
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Pfizer
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Keywords:
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adaptive design ;
up-and-down design ;
dose-finding
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Abstract:
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This presentation will focus on identifying the range of doses with a particular event rate < = 3% after 4 weeks of dosing in a diabetes trial. The traditional approach is to use a parallel group design. Given the 3% cutoff, the sample size per group in a parallel group design needs to be decent. As a result, the number of doses which can be studied is limited with a capped budget. Therefore an adaptive cohort up-and-down design is considered. However, the study team is reluctant to accept the resulted long study duration, which obviously delays the development timeline. Finally a modification of well-known cohort up-and-down design is proposed to meet the need of budget constraint and timeline constraint.
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Authors who are presenting talks have a * after their name.
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