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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
President, Two Legs Consulting LLC, United States
Longitudinal Psychometric Evaluation
Laura Lee Johnson, PhD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
Interpretation of Scores
Lisa A Kammerman, PhD, MS
Regulatory Statistics and PRO Consultant, Kammerman Consulting, LLC, United States
Panel Discussion Moderator
Paivi Miskala, PhD
Endpoints Reviewer, Study Endpoints and Labeling Development, CDER, FDA, United States
Panel Discussion
Cynthia A Bens
Senior Vice President, Public Policy, Personalized Medicine Coalition, United States
Jeremy Hobart, PhD, FRCP
Professor, Clinical Neurology and Health Measurement , Peninsula College of Medicine and Dentistry, United Kingdom
Laura Lee Johnson, PhD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
Lisa A Kammerman, PhD, MS
Regulatory Statistics and PRO Consultant, Kammerman Consulting, LLC, United States
Patrick Marquis, MD, PhD, MBA, FACP
President, Two Legs Consulting LLC, United States
Elektra Papadopoulos, MD, MPH
Director, Patient Experience Data and Strategy, AbbVie, United States
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