DIA 48th Annual Meeting
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Labeling Claims Based on Patient-reported Outcome Measures: It Takes a Village!
Track : Track 07: Processes and Technologies for Clinical Research
Program Code: 223
Date: Tuesday, June 26, 2012
Time: 10:00 AM to 11:30 AM  EST
J. Jason Lundy, Critical Path Institute, United States
J. Jason Lundy, Critical Path Institute, United States
 Clarice (Risa) Hayes, Eli Lilly and Company, United States
 James Stansbury, FDA, United States
A pragmatic overview will be provided that delineates the series of activities necessary to properly develop and implement a patient-reported outcome (PRO) measure in a clinical trial for the purposes of product approval and labeling. During this interactive forum, a real-world example will be used to illustrate the considerations and associated resources that a clinical trial sponsor may face when using a PRO instrument as an efficacy endpoint.

Learning Objectives:
Define the various steps in developing PRO instruments suitable for product approval and labeling
Describe the considerations related to the implementation of a PRO measure in a clinical trial
Identify the procedures for obtaining FDA feedback on PRO instruments intended to support claims in medical product labeling.