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

Abstract Details

Activity Number: 625
Type: Contributed
Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #307433
Title: How to Handle Placebo Data in Dosing Ranging Studies Using 2-by-2 Crossover Design
Author(s): Xin Zhao*+
Companies: Merck & Co., Inc.
Address: , , ,
Keywords: crossover design ; linear mixed model ; dose ranging studies
Abstract:

A classic dose ranging study will have multiple parallel arms for multiple doses of investigational drug and placebo. Recently, 2-by-2 crossover design start to be utilized in dose ranging studies to reduce patients cost by utilizing within-patient treatment comparisons. Specifically, a 2-by-2 crossover for each dose may be implemented and hence the study will have the same number of 2-by-2 crossovers (each crossover has 2 sequences) as the number of the doses investigated . This design will have a lot of placebo data. The talk will discuss how to handle these placebo data appropriately.


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