JSM 2011 Online Program

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Abstract Details

Activity Number: 14
Type: Topic Contributed
Date/Time: Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
Sponsor: International Chinese Statistical Association
Abstract - #302365
Title: Inference in Designs with Interim Treatment Selection by a Flexible Selection Margin
Author(s): Yujun Wu*+ and Yunwen Yang and Peng-liang Zhao
Companies: sanofi-aventis and University of Illinois at Urbana-Champaign and sanofi-aventis
Address: 15 McElroy Ln, Belle Mead, NJ, 08502, USA
Keywords: adaptive design ; interim treatment selection ; estimation ; clinical trials
Abstract:

A two-stage adaptive design with selection of the treatments at the interim stage has been introduced by Wu and Zhao (2009). The design specifies a selection margin which is used to define the acceptable interim treatment effects for further consideration. On one hand, this margin allows the selection of more than one arm at the interim stage; on the other hand, it plays as a futility rule to stop the treatment arms with significantly inferior effect when compared to the arm with the highest mean response. Statistical inference including hypothesis testing and point estimation are discussed for the general cases with no limitations on the number of treatment arms in the study. The case with binary endpoint is also discussed.


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