DIA 48th Annual Meeting
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PRO Measurement in Clinical Trials: Need for Education and Training
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
159
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Josephine Norquist, Merck Sharp & Dohme Corp., United States
PRESENTER
(S):
Josephine Norquist, Merck Sharp & Dohme Corp., United States
Laurie Burke, FDA, United States Clarice (Risa) Hayes, Eli Lilly and Company, United States
Description
This session will present two examples of initiatives in pharmaceutical companies for PRO education and training as well as present the current initiatives being developed through the PRO Consortium, a partnership between pharmaceutical companies and the FDA to develop qualified, PRO endpoints to support product labeling claims.
Learning Objectives:
Discuss the importance of PRO measures in drug development
Demonstrate best practices within pharmaceutical companies on how to implement more efficient and consistent approaches to endpoint development, validation, and implementation
Demonstrate methods to establish educational and training programs in PRO measurement within pharmaceutical companies Identify the need for PRO education and training for a broader audience including academic, government, and other industry groups.
Learning Objectives:
Discuss the importance of PRO measures in drug development
Demonstrate best practices within pharmaceutical companies on how to implement more efficient and consistent approaches to endpoint development, validation, and implementation
Demonstrate methods to establish educational and training programs in PRO measurement within pharmaceutical companies Identify the need for PRO education and training for a broader audience including academic, government, and other industry groups.
This session is a part of:
Handout Online
