This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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541
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 4, 2010 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #308756 |
Title:
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Multiplicity Issues in Multidomain Patient Reported Outcome (PRO)--Based Endpoints
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Author(s):
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Mahboob Sobhan*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Av, Silver Spring, MD, 20993,
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Keywords:
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Multiplicity ;
Patient reported outcome
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Abstract:
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Efficacy endpoint(s) based on multidomain patient reported outcome (PRO) measures are often proposed to support labeling claim. In this discussion, we like to emphasize the regulatory requirement in designing such PRO based studies, including statistical considerations. Examples will be given to highlight the need for a priori design consideration in the clinical development.
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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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