Spoke-3-and-4-Completing-the-Dossier-Reliability-Construct-Validity-Ability-to-Detect-Change-and-Interpretation-Metrics

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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

After content validity is demonstrated, other measurement properties specific to the context of use, need to be demonstrated. This session is dedicated to research methods for identifying the other measurement properties—reliability, construct validity, and the ability to detect change. In addition the metrics of clinically meaningful change in the particular context of use will be discussed.

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 A 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 A 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

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes