This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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117
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 2, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307232 |
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Title:
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How to Define Regions in Multiregional Clinical Trials
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Author(s):
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Qi Zhang*+ and Yoko Tanaka
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Companies:
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Eli Lilly and Company and Eli Lilly and Company
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Address:
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, , ,
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Keywords:
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MRCT ;
regions
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Abstract:
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Pharmaceutical, biotech and device companies have embraced globalization as a core component of their business models, especially in the realm of clinical trials. The globalization of clinical research is a relatively recent phenomenon. One of the key challenges of the globalization of clinical research is how to define "region". This talk will discuss research conducted by the MRCT Key Issue Team (KIT) on the definition of regions and the impact of those definitions. This research explores a number of definitions for regions from the perspectives of 1) general points to consider for defining regions, 2) therapeutic area level examples, and 3) influencing factors such as culture, ethnicity, language, medical practice.
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