This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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663
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306352 |
Title:
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Design and Trial Operational Considerations for a Phase II Two-Stage Adaptive Trial
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Author(s):
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Weili He*+ and Madhuja Mallick and Yevgen Tymofyeyev and James A. Bolognese
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc. and Cytel Inc.
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Address:
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Clinical Biostatistics, RY 34-A316 , Rahway, NJ, 07065,
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Keywords:
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adaptive design trial ;
Type I error ;
sample size re-estimation ;
futility check ;
trial operation issues
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Abstract:
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We design a two-stage adaptive design for the purposes of proof of concept and obtaining preliminary dose response information for a new chemical entity. Patients will be randomized to receive a high dose of test drug, placebo, and an active control during Stage I. During Stage II, a lower dose of test drug will be added in addition to the treatment arms in Stage I. Since the trial serves multiple purposes, we consider several design issues: a) assessment of futility, b) evaluation of assay sensitivity, and c) sample size re-estimation. We propose criteria for these evaluations. We consider and discuss the methods and the implications on the type I error rate. A simulation study evaluating the study design characteristics will be presented. Additionally, trial operation issues arise from the implementation of a complex adaptive design trial. We will describe the issues and the imple
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