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Abstract Details
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Activity Number:
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454
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306197 |
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Title:
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Contemporary and Historical Controlled Trial Design Using Propensity Score Method: A Reviewer's Perspective
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Author(s):
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Xiting Yang*+ and Yunling Xu
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Companies:
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FDA and FDA
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Address:
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10903 New Hampshire Av., Silver Spring, MD, 20993-0002, United States
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Keywords:
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prespective design ;
propensity score ;
contempory and historical controlled trial
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Abstract:
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Though concurrent randomized controlled trial (RCT) is the gold standard in a clinical trial design, sometimes RCT is not possible due to ethical and practical reasons. Sometimes a contemporary control or a historical control can be used in a medical device trial, but only with a prospective design. Often, propensity score analysis is used. This talk shares some of the experience in prospectively designing a contemporary or historical controlled trial using propensity score method from a statistical reviewer's perspective.
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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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