JSM 2004 - Toronto

Abstract #301298

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Activity Number: 274
Type: Contributed
Date/Time: Tuesday, August 10, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301298
Title: Issues in the Application of Microarray Data in a Clinical Trial
Author(s): Bret J. Musser*+
Companies: Merck & Co., Inc.
Address: 126 E Lincoln Ave, Rahway, NJ, 07065,
Keywords: microarray ; clinical trial ; crossover ; variance components
Abstract:

The clinical application of microarray data has typically been in an observational setting. This presentation will discuss uses of microarray data in a phase I clinical trial. There are a number of specific issues that arise in a clinical trial setting for the use of microarray data. In a clinical trial, there are limits to the types and quantities of samples that can be taken from healthy volunteers. Invasive tissue sampling limits the number of volunteers and samples per volunteer, thus careful attention must be paid to the sources of error, including errors in sample collection and handling, and the typical inter- and intra-subject variation. The impact of these sources of variability on the power of the study will be discussed. I will present an overview of a proposed experiment and then focus on the design of the sampling scheme for the study. Real and/or simulated data are shown to justify the proposed design.

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Revised March 2004