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Activity Number: 325
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #317156 View Presentation
Title: General Mixture-Based Gatekeeping Procedures in an Adaptive-Design Setting
Author(s): George Kordzakhia* and Alex Dmitrienko and Eiji Ishida
Companies: FDA and Quintiles and FDA
Keywords: adaptive design ; gatekeeping procedures ; multiple testing
Abstract:

Testing of multiple clinical objectives in clinical trials that employ adaptive designs has recently attracted attention in the multiple comparison literature. This presentation considers a general framework for setting up mixture-based gatekeeping procedures in clinical trials with several decision points. It is assumed that the null hypotheses of interest are grouped into families to reject their clinical importance. The framework supports powerful component procedures applied within each family and serial logical relationships among the null hypotheses in different families. The approach is illustrated by applying it to a common class of multivariate multiplicity problems with multiple sequences of hypotheses. This is a joint work with Alex Dmitrienko and Eiji Ishida.


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