JSM Preliminary Online Program
This is the preliminary program for the 2006 Joint Statistical Meetings in Seattle, Washington.

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Activity Number: 97
Type: Topic Contributed
Date/Time: Monday, August 7, 2006 : 8:30 AM to 10:20 AM
Sponsor: ENAR
Abstract - #306930
Title: Delivering Robust Outcomes from Multiregional Clinical Trials
Author(s): Yoko Tanaka*+
Companies: Eli Lilly and Company
Address: Lilly Corporate Center, DC 6166, Indianpolis, IN, 46285,
Keywords: heterogeneity ; multi-regional ; generalizability
Abstract:

Principles and strategies are considered for addressing heterogeneity due to geographic diversity in multiregional clinical trials. This diversity can be the result of differences in race, culture, standard of care, and/or quality of data across regions---each of which will be discussed. In light of these various sources of variability, we will consider implications of global data to specific regions and the generalizability of results. An important focus throughout will be the question of what constitutes an internally consistent global trial.


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Revised April, 2006