Abstract Details
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Activity Number:
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53
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Type:
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Invited
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Date/Time:
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Sunday, August 4, 2013 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306975 |
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Title:
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Challenges and Opportunities with Observational Studies: A CDRH's Perspective
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Author(s):
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Lilly Yue*+
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Companies:
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U.S. FDA
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Keywords:
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Observational study ;
study design ;
control group selection ;
treatment group comparability
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Abstract:
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In the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration, observational studies play a substantial role in both pre-market and post-market safety/effectiveness evaluations of medical products. However, the special nature of medical device clinical studies presents unique challenges in study design, conduct and analysis, such as prospective study design, control group selection and treatment group comparability. In this presentation, some of such challenges will be discussed and illustrated with examples from a regulatory perspective.
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Authors who are presenting talks have a * after their name.
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