JSM Preliminary Online Program
This is the preliminary program for the 2008 Joint Statistical Meetings in Denver, Colorado.

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Activity Number: 152
Type: Roundtables
Date/Time: Monday, August 4, 2008 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301412
Title: How Not To Be Lost in Translation: Expanding Roles for Consultant Statisticians in the Era of Multinational Drug Development
Author(s): Yoko Adachi*+
Companies: U.S. Food and Drug Administration
Address: 7500 Standish Pl, Rockville, MD, 20855,
Keywords: Multi-Region ; Consulting ; International Clinical Trials ; Regulatory Difference ; Cultural Barriers ; Biostatistics
Abstract:

As more clinical trials are conducted in regions other than the United States and Western Europe, various issues emerge for consultant statisticians who work with sponsors with various backgrounds in terms of nationality, resources, and drug development experiences. This discussion will focus on opportunities and challenges consultant biostatisticians face when a drug is developed and marketed, such as regulatory differences, cultural barriers, and communication issues.

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Revised September, 2008