JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 233
Type: Contributed
Date/Time: Monday, August 3, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305332
Title: Optimal Treatment Allocation for a 2-Period, M Treatment Clinical Trial with Fixed Subject Total
Author(s): Theodore C. Lystig*+
Companies: Boehringer Ingelheim Pharmaceuticals, Inc.
Address: 900 Ridgebury Road, Ridgefield, CT, 06877-0368,
Keywords: experimental design ; power ; sample size ; dependent data ; clinical trials
Abstract:

We are interested in comparing different possible designs for a two period clinical trial with a fixed number n of subjects, and a moderate number M of treatments, one of which is placebo. Due to various logistical constraints, using 2n subjects for a single visit each is not a possible alternative. Let the optimality of a candidate treatment design be measured by the variance of the treatment contrast testing for the difference between placebo and any of the other M-1 treatments. What is the optimum set of two period treatment sequences to which patients should be randomly assigned? We derive simple analytical expressions for the variance of the treatment contrast for several interesting candidate designs, as well as the general case, and display the results graphically. Connections to other means of evaluating and obtaining optimal study designs will be explained.


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