JSM 2005 - Toronto

Abstract #303572

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 149
Type: Luncheons
Date/Time: Monday, August 8, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303572
Title: Issues in the Use and Interpretation of Subgroup Analyses in Clinical Trials
Author(s): Cristiana Gassmann-Mayer*+
Companies: Johnson & Johnson
Address: 1125 Trenton Harbourton Road, Titsuville, NJ, 08560, United States
Keywords: subgroup analysis ; clinical trials ; treatment effect
Abstract:

An important issue in clinical trials is the evaluation of treatment effects across groups of patients. As it is commonly believed that samples in clinical studies are not homogeneous populations, one needs to address the ethical question of identifying how and what subgroups of patients would benefit more from the treatment under investigation. Common sources of improper subgroup analyses and their misinterpretation will be discussed. Special consideration will be given to the exchange of ideas, experiences, and suggestions to handle subgroup analyses. Are the "subgroup of statisticians" and the "subgroup of clinicians" involved in a clinical trial significantly different in terms of approaching and interpreting subgroup analyses?

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Revised March 2005