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Abstract Details
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Activity Number:
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165
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305342 |
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Title:
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Elicitation of Patient Preference for Risk Tolerance of Weight Reduction Devices in Obese Population
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Author(s):
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Martin Ho*+
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Companies:
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FDA/CDRH
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Address:
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10903 New Hampshire Ave, Silver Spring, MD, , USA
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Keywords:
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Patient Risk Tolerance ;
Medical Device ;
Preference Elicitation
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Abstract:
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To explore how to incorporate patient's input in regulatory decision making, FDA's Center for Devices and Radiological Health sponsored the Agency's first patient risk tolerance survey. The purpose of this survey is to elicit the maximum risk tolerance of obese population in exchange for specific level of weight reduction for devices with combinations of attributes such as the safety profiles and diet restrictions. After describing the motivation behind this survey, I will explain the statistical methodology behind the study and discuss the potential role of the result in CDRH's regulatory process.
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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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