This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 117
Type: Topic Contributed
Date/Time: Monday, August 2, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #306900
Title: Multinational Clinical Trials: A Perspective from Latin America
Author(s): Carolina Cernadas*+
Companies: Schering Plough Argentina
Address: , , , Argentina
Keywords: Multinational trials ; power ; variance ; latin america
Abstract:

An increasing number of multinational trials to support marketing approval in the US have been implemented. One important issue is the unexpected sources of variability. Factors such as local demographics, ethnicity, medical practices and investigators training, may differ among the regions and impact the final outcomes. These factors often present statistical challenges and lead to nuisance qualitative interactions amoung different regions. Having more accurate definitions of regions and a better understanding of relevant variables such as demographic, cultural and economical factors in the design stage is important to minimize nuisance variability, properly power the trial and to obtain meaningful and relevant results. The Latin American region will be used as an example.


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