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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394
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307752 |
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Title:
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Strategies for Global Drug Development: Bridging vs. Multiregional Clinical Trials
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Author(s):
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William Wang*+ and William Malbecq
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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28 Floor, Park Place, Shanghai, 200040, China
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Keywords:
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Bridging ;
MRCT ;
Regional Consistency
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Abstract:
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In recent years, there has been an increasing trend by multinational companies to perform global clinical trials in emerging market regions. This presentation will feature the current state of clinical trials in Asia Pacific region. We will discuss some region-specific statistical considerations such as sample size requirements, statistical significance and regional consistency. We will also discuss the pros and cons of two different types of strategies: those using bridging trials versus those using multi-regional clinical trials (MRCTs). Simulations will be used to evaluate these strategies.
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Authors who are presenting talks have a * after their name.
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