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Activity Number: 161
Type: Luncheons
Date/Time: Monday, August 7, 2006 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305595
Title: What Are the Statistical Issues in Subgroup Analysis - Design, Analysis, and Interpretation?
Author(s): Chul H. Ahn*+
Companies: U.S. Food and Drug Administration
Address: 1350 Piccard Drive, CDHR, Rockville, MD, 20850,
Keywords: multiplicity ; familywise error ; subgroup p-value ; interaction test ; data dredging ; regression to the mean
Abstract:

Subgroup analysis appears in almost every device or drug clinical trial. When the sponsor reports the results by demographic variables, they immediately run into subgroup analysis problems. In this discussion, we will consider two major problems in subgroup analysis---multiple testing and statistical power---among others. Then, subgroup analysis will be discussed in more detail in design, analysis, and interpretation.


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