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Patient Voice and its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures
Session Chair(s)
Alexander Varond, JD
Partner, Goodwin Procter LLP, United States
Patients are playing an increasing role in drug development. This session discusses on one area where this true -- in understanding clinical meaningfulness and selection and development of clinical outcome measures.
Learning Objective : Develop endpoints that capture individuals' most burdensome aspect of the disease; Identify the role of the patient voice in endpoint selection and assessment.
Speaker(s)
Patroula Smpokou, MD
Division Director , FDA, United States
FDA Perspective
Alison Skrinar, PhD, MPH
Vice President, Clinical Outcomes Research and Evaluation, Ultragenyx Pharmaceutical, United States
Industry Perspective
James Valentine, JD, MHS
Director, Hyman, Phelps & McNamara, PC, United States
Patient Perspective
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