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

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Activity Number: 325
Type: Contributed
Date/Time: Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305841
Title: Subgroup Heterogeneity in Drug Efficacy
Author(s): Qiang (Casey) Xu*+ and Rajeshwari Sridhara and Shenghui Tang and Yu-Ling Chang
Companies: FDA and FDA and FDA and FDA
Address: CDER, Silver Spring, MD, ,
Keywords: Clinical Trials ; Subgroup Analysis ; Baseline Comparison ; Biomarker
Abstract:

Heterogeneous treatment efficacy across special subgroups in clinical trials has been frequently observed in various therapeutic areas. Recent multi-region studies and effect modifying biomarkers, such as K-ras mutation in oncology studies, push this issue to a more prominent position than ever. The impact of (1) quantitative or qualitative treatment by subgroup interaction, (2) subgroup sample size, and (3) non-random sampling on the behavior of subgroup analyses in terms of false-positive rate, false negative rate and estimation bias, are examined using simulation studies. Rules of planning, analysis, and interpreting of subgroup analyses in clinical trials, especially in oncology trials, are proposed.

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