Abstract Details
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Activity Number:
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599
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Type:
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Contributed
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Date/Time:
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Wednesday, August 7, 2013 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308532 |
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Title:
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Simulations to Evaluate the Impact of Multiplicity Adjustment Procedure Selection in Clinical Trial Design
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Author(s):
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Bidan Huang*+ and Yaqin Wang
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Companies:
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AbbVie and AbbVie Inc.
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Keywords:
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multiplicity ;
controlling family-wise error rate
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Abstract:
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Controlling family-wise error rate (FWER) in confirmatory trials is becoming more strictly enforced by regulatory agencies. In addition, sponsors are conducting more and more phase 3 trials with multiple endpoints and more than one dose of study drug. Methods for controlling FWER (eg, Bonferroni, Hochberg, and Fixed Sequence methods for single family of hypotheses, as well as serial and parallel gatekeeping methods for hypotheses grouped into multiple families) are well-understood. However, when it comes to a specific project, which method to apply for multiplicity adjustment is less obvious. Simulation results are presented to show the comparisons of the operating characteristics of various methods, based on degree of dose-response and correlation between primary and secondary endpoints.
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Authors who are presenting talks have a * after their name.
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