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Activity Number: 30
Type: Contributed
Date/Time: Sunday, August 3, 2014 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #313246 View Presentation
Title: An Adaptive Cohort Up-and-Down Design to Identify Doses with a Low Event Rate When the Study Duration Is Fixed
Author(s): David Li*+
Companies: Pfizer
Keywords: adaptive design ; up-and-down design ; dose-finding
Abstract:

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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