Objective

The task force’s goal is to improve the evaluation and documentation of content validity and other measurement properties including reliability, construct validity, and ability to detect change for PerfO assessments and to provide detailed recommended good practices for clinical trial implementation, allowing for more precise and reliable measurement and interpretation of treatment benefit. The task force reports will address PerfO assessments of physical function (e.g., mobility), cognitive function (e.g., working memory) or cognition-dependent function (e.g., instrumental activities of daily living), and sensory function (e.g., low contrast visual acuity). While PerfO assessments may also be used for diagnostic purposes and in clinical practice, these uses are outside the task force’s scope, which is focused on their use as outcome measures in clinical trials.

Rationale

Very little has been published on evaluating content validity and measurement properties of PerfO assessments especially in the context of drug (or device) labeling. This task force will be providing guidance on a topic where interest is growing due to its use in rare diseases and cognitively impaired populations. It is crucial that good measurement practices are developed and refined to optimize their development and use.

Co-Chairs:

Elizabeth (Nicki) Bush

Elizabeth (Nicki) Bush

Global Head, Patient-Focused Outcomes Center of Expertise, Eli Lilly and Company
Indianapolis, IN, United States
Stephen Joel Coons

Stephen Joel Coons, PhD

Senior Vice President, Critical Path Institute
Koloa, HI, United States
Christopher Edgar

Christopher Edgar, MSc, PhD

Chief Science Officer, Cogstate
New Haven, CT, United States

Leadership Group

Heather Adams, PhD

Associate Professor, University of Rochester Medical Center
Rochester, NY, United States

Rachel Ballinger, PhD, BSc

Principal, ICON
Reading, RDG, United Kingdom

Bill Byrom, PhD, BSc

Vice President of Product Strategy and Innovation, Signant Health
Nottingham, NTT, United Kingdom

Michelle Campbell, PhD

Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, Division of Neurology Products, Office of New Drugs (OND), CDER, Food and Drug Administration
Silver Spring, MD, United States

Wen-Hung Chen, PhD

Specialty Care, General Medicines & Vaccine Lead, Patient-Centered Outcomes, GSK
Collegeville, PA, United States

Helen Doll, MSc, DPhil

Strategic Lead, Quantitative Science, Clinical Outcomes Solutions
Folkestone, Kent, United Kingdom

Sonya Eremenco, MA

Executive Director, PRO Consortium, Critical Path Institute
Tucson, AZ, United States

Fiona McDougall, Mphil, PhD, BSc

Associate Director, Genentech
South San Francisco, CA, United States

Bray Patrick-Lake

Director of Strategic Partnerships, Evidation Health
San Mateo, CA, United States

Ashley Slagle, MS, PhD

Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC
Steamboat Springs, CO, United States
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