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 - #308782 |
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Title:
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Exploration of Regional Impact on Efficacy Data in Antidepressant Clinical Trials
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Author(s):
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Peiling Yang*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Ave, Silver Spring, MD, 20993,
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Keywords:
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Major Depressive Disorder ;
Multi-regional Trials
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Abstract:
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In this era of globalization of clinical trials, increasingly clinical trial data submitted in new drug applications are generated outside the US. A consistently significant rate of failed trials and the high rate of placebo response have been the main concern for clinical trials in major depressive disorder (MDD). In this talk we will explore the potential regional impact on efficacy data from placebo-controlled MDD trials that were submitted in support of new drug applications over the past 25 years.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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