This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 541
Type: Roundtables
Date/Time: Wednesday, August 4, 2010 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308756
Title: Multiplicity Issues in Multidomain Patient Reported Outcome (PRO)--Based Endpoints
Author(s): Mahboob Sobhan*+
Companies: FDA
Address: 10903 New Hampshire Av, Silver Spring, MD, 20993,
Keywords: Multiplicity ; Patient reported outcome
Abstract:

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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