This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 226
Type: Topic Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306535
Title: Choice of Multiple Comparison Procedure in Two Pivotal Clinical Trials for Approval of a New Pharmaceutical Product: Power and Aesthetics
Author(s): Brian L. Wiens*+ and Alex Dmitrienko
Companies: Alcon Laboratories, Inc. and Eli Lilly and Company
Address: 6201 South Freeway, Fort Worth, TX, 76134,
Keywords: fallback procedure ; fixed sequence ; weighted Holm ; closed test ; clinical trials
Abstract:

We consider analysis of two identical pivotal trials with correlated multiple endpoints evaluated by the fixed sequence, weighted Holm or fallback procedure. For approval, at least one endpoint must be significant in both studies. Evaluation of the procedures as closed tests distinguishes which has better power in different situations. The fixed sequence procedure has the highest power to reject the first hypothesis and to reject all three hypotheses. The fixed sequence often has the highest chance of obtaining inconsistent results, which makes it less aesthetically pleasing. The weighted Holm and fallback procedures have very similar properties. Under some plausible assumptions, we find weights that maximize or minimize power differences between the fallback and weighted Holm procedure, and provide practical guidance on which is preferable.


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