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:

Stephen Joel Coons, PhD, Executive Director, Patient-Reported Outcome (PRO) Consortium and Program Officer, Clinical Outcome Assessment Program, Critical Path Institute, Tucson, AZ, USA

Elizabeth Nicole (Nicki) Bush, MHS, Director, Patient Focused Outcomes Center of Expertise, Global Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly and Company, Indianapolis, IN, USA

Leadership Group:

Heather R. Adams, PhD, Pediatric Neuropsychologist, University of Rochester,
Rochester, NY, USA  

Rachel Ballinger, PhD, Lead Outcomes Researcher, ICON, Abingdon, England, UK

Eric Bastings, MD
, Medical Reviewer, Division of Neurology Products, CDER, FDA,
Silver Spring, MD, USA

Helen Doll, DPhil, Senior Principal, Clinical Outcomes Assessments, Clinical Outcomes Solutions, Oxford, England, UK
Sonya Eremenco, MA, Associate Director, PRO Consortium, Critical Path Institute,
Tucson, AZ, USA

Richard S.E. Keefe, PhD, CEO, NeuroCog Trials and Professor, Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA

Jordi Llinares Garcia, MD
, Head of Product Development Scientific Support, EMA,
London, England, UK

Jay Magaziner, PhD, University of Maryland School of Medicine and School of Public Health, Baltimore, MD, USA

Fiona McDougall, PhD, Senior Scientist, Roche, London, England, UK

Elektra Papadopoulos, MD
, Associate Director, COA Staff, OND, CDER, FDA,
Silver Spring, MD, USA

Ashley Slagle, PhD, Aspen Consulting, Philadelphia, PA, USA

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