JSM 2005 Online Program

Abstract #302598

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	506
Type:	Invited
Date/Time:	Thursday, August 11, 2005 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #302598
Title:	Statistical Considerations in Designing PGx Study Using Microarray Technology
Author(s):	Nanxiang Ge*+
Companies:	Sanofi-Aventis
Address:	Mail Stop B-203C. PO Box 6800, Bridgewater, NJ, 08807-6800, USA
Keywords:	Microarray ; Pharmacogenomics ; Study power ; trial design
Abstract:	Microarray technology, originated in drug discovery, has shown more and more applications in clinical studies. Applying microarray technology in clinical trial introduces many challenging statistical issues. There are at least two scenarios where microarray technology can be used prospectively. First, used within a large phase III trial. Second, used in two subsequent trials with the first one used as a marker identification trial and the second used as a prospective validation trial. For the first type of application, one needs to decide how to allocate enrolled subjects into training and validation sets such that the training set will have reasonable statistical power to identify a set of markers for predicting treatment outcome difference and the validation set will have enough power to demonstrate the treatment outcome difference. For the second type of application, similar questions need to be addressed. In this paper, using one internal example, we will try to shed some lights on these questions via simulation as well as theoretical investigations.

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