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Pediatric Engagement in Research: Young People Have a Voice
Session Chair(s)
Elisa Koppelman, MPH
Team & Program Director
MRCT Center, United States
The importance of pediatric patient and parent (or guardian) engagement and input in all aspects of clinical research and product development is increasingly recognized, although not consistently practiced, particularly in pediatric research. This forum will discuss why it is critical to get decision makers (industry sponsors, IRBs/ethics committees, regulatory agencies, patient community) to buy in to the concept; who is involved in the data collection via exploration of the qualitative methodologies that explicitly and systemically gather data to build "representativeness" into the process; include exploration of what constitutes sufficiency of evidence; and how to gather data creatively and effectively by sharing practical considerations for patient and parent or guardian and sponsor interaction.
Learning Objective : Discuss the ways IRBs, ethics committees and regulators currently view/utilize patient/family input; Describe approaches for enhanced incorporation of the patient/family perspective into the lifecycle of product development.
Speaker(s)
Panelist
Albert Allen, MD, PHD, MSC
A. J. Allen Pediatric Drug Development Consulting, United States
Consultant
Panelist
Gianna McMillan, PHD
Loyola Marymount University, United States
Bioethics Institute, Associate Director
Panelist
Nathalie Bere, MPH
European Medicines Agency, Netherlands
Patient Engagement
Panelist
Jennifer Denise Preston
University of Liverpool, United Kingdom
Senior Patient and Public Involvement Manager, Dept of Women & Children's Health