This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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408
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Type:
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Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307801 |
Title:
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Interval Estimation in Two-Stage, Drop-the-Losers Clinical Trials with Flexible Treatment Selection
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Author(s):
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Dan Neal*+ and George Casella and Mark Yang and Samuel S. Wu+
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Companies:
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University of Florida and University of Florida and University of Florida and University of Florida
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Address:
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1329 SW 16th Street Room 5231, Gainesville, FL, 32610-0177, 1329 SW 16th Street Room 5231, Gainesville, FL, 32610, USA
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Keywords:
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Flexible selection ;
clinical trial ;
drop-the-losers design ;
p-value combination ;
two-stage test
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Abstract:
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In a two-stage, drop-the-losers clinical trial, the ``best" among a number of treatments is chosen at an interim analyis after the first stage. The selected treatment continues into the second stage for confirmation of efficacy while the remaining treatments (the ``losers") are dropped from the study. Wu et al.(Biometrika, in press) showed how to construct confidence limits for the mean difference between the selected treatment and the control when the treatment is chosen based on highest efficacy in the primary clinical endpoint. We show how to construct a lower confidence limit for the mean difference when the treatment is chosen based on first-stage safety data, early endpoint efficacy data, or any other selection rule. The result extends the applicability of drop-the-losers designs, for in practice, the "best" treatment often is not chosen for efficacy alone.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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