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Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22
Session Chair(s)
Bennett Levitan, MD
Executive Director, Benefit-Risk Assessment / Epidemiology
Johnson & Johnson, United States
This workshop explores integrating patient preference studies into clinical trial design and drug application submissions, highlighting operational strategies, stakeholder collaboration, and how these align with the upcoming ICH E22 guideline.
Learning Objective : Recognize key aspects of patient preference studies (PPS) design using a practical, interactive preference elicitation example; Describe how to incorporate PPS into clinical trial design and regulatory decisions using insights from ICH E22; Identify key operational strategies and challenges in designing PPS.
Speaker(s)
Patient Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Megan Aragon, MBA
East Texas Lighthouse for the Blind, United States
Technology Services Administrator
Regulatory Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Representative Invited
FDA, United States
Industry Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Leila Lackey, MHS, PHD
Pfizer, United States
Director, Patient Preference Evidence Generation
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