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

Abstract Details

Activity Number: 329
Type: Topic Contributed
Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306418
Title: Comparing Adaptive and Traditional Crossover Designs for Dose-Finding Trials
Author(s): James A. Bolognese*+ and Nitin R. Patel and Byron Jones
Companies: Cytel Inc. and Cytel Inc. and Pfizer Inc.
Address: 675 massachusetts ave, cambridge, MA, 02139, usa
Keywords: adaptive design ; crossover ; T-statistic ; 2-stage design ; incomplete block ; dose response
Abstract:

This talk presents simulation results under a range of monotone or near monotone dose response scenarios and sample sizes comparing effectiveness of adaptive cross-over designs with traditional cross-over designs. Effectiveness measures are the probability of detecting a dose response, the probability of selecting a dose that gives a desired response relative to placebo and number of subjects allocated to the target dose. The comparisons are carried out for several different values for key variables including sample size, variance, target level of response, patient accrual rate and number of interim looks. The adaptive cross-over design is based on the T-statistic (Ivanova, et al. 2008) and compared to a 2-stage procedure with all doses at Stage 1, and only the promising doses at Stage 2, and to a corresponding fixed sample size incomplete block crossover design.


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