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Spoke 3 and 4: Completing the Dossier: Reliability, Construct Validity, Ability to Detect Change, and Interpretation Metrics
Session Chair(s)
Paivi Miskala, PhD
Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
FDA, United States
Speaker(s)
Practical Consideration when Planning the Evaluation of Measurement Properties
Patrick Marquis, MD, PhD, MBA, FACP
Two Legs Consulting LLC, United States
President
Longitudinal Psychometric Evaluation
Laura Lee Johnson, PhD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
Interpretation of Scores
Lisa Kammerman, PhD, MS
Kammerman Consulting, LLC, United States
Regulatory Statistics and PRO Consultant
Panel Discussion Moderator
Paivi Miskala, PhD
FDA, United States
Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
Panel Discussion
Cynthia A Bens
Personalized Medicine Coalition, United States
Senior Vice President, Public Policy
Jeremy Hobart, PhD, FRCP
Peninsula College of Medicine and Dentistry, United Kingdom
Professor, Clinical Neurology and Health Measurement
Laura Lee Johnson, PhD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
Lisa Kammerman, PhD, MS
Kammerman Consulting, LLC, United States
Regulatory Statistics and PRO Consultant
Patrick Marquis, MD, PhD, MBA, FACP
Two Legs Consulting LLC, United States
President
Elektra Papadopoulos, MD, MPH
AbbVie, United States
Director, Patient Experience Data and Strategy
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