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Activity Number: 302
Type: Topic Contributed
Date/Time: Tuesday, August 6, 2013 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #309880
Title: Decisionmaking in Confirmatory Multipopulation Tailoring Clinical Trials
Author(s): Brian Millen*+ and Alexei Dmitrienko
Companies: Eli Lilly & Company and Quintiles
Keywords: multiple testing ; interaction condition ; influence condition ; subgroup analysis ; tailoring
Abstract:

This talk focuses on statistical analyses of clinical trials pursuing tailored therapy objectives wherein evaluation of treatment effect occurs within an overall population as well as within a predefined subpopulation. Design and analysis principles which provide a framwork for decision making in these novel multipopulation tailoring trial designs will be presented for the confirmatory trial setting.


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