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Activity Number: 526
Type: Topic Contributed
Date/Time: Wednesday, August 12, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #316772
Title: Visualizing Multiple Objectives in Flexible and Group Sequential Designs
Author(s): Florian Klinglmueller*
Companies: Medical University Vienna
Keywords: Adaptive design ; Group sequential design ; Multiple Testing
Abstract:

We present adaptive graph-based multiple testing procedures for clinical trials that permit early rejection of elementary hypotheses and provide the flexibility to perform interim trial modifications based on unblinded observations from the ongoing trial. The underlying multiple testing procedure can be tailored using an intuitive graphical approach. During the ongoing trial and based on unblinded observations one may, reassess and modify the preplanned sample sizes; modify the multiple testing procedure; introduce additional or change the timing of interim analyses; and add or drop treatments and - or hypotheses. The procedure uses a combination of the closed testing principle with the partial conditional error rate approach to ensure strong control of the family-wise error rate even if the correlation structure between test statistics is unknown. Moreover, if present the procedure will exploit any positive correlation between test statistics.


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