Peer-Reviewed Publication
Value Health2026September 28, 2026Journal Article
Recommendations on the Implementation of Performance Outcome Assessments in Clinical Trials: A Good Practices Report of an ISPOR Task Force.
Elizabeth Nicki Bush1, Chris J Edgar2, Heather Adams3, Alexandra Atkins4, Bill Byrom5, Michelle Campbell6, Heather Dickerson7, Sonya Eremenco8, Naomi Knoble9, Fiona McDougall10, Elektra Papadopoulos11, Ashley F Slagle12
1Critical Path Institute, Tucson, AZ. Electronic address: enbush@gmail.com.
2PCOA Associates Ltd, Whitchurch Hill, UK.
3University of Rochester, Rochester, NY, USA.
4Eli Lilly and Company, Indianapolis, IN, USA.
5Signant Health, Sandwich, UK.
6Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
7Patient Centered Outcomes, ICON, St. Albans, UK.
8Patient-Centered Evidence Consortium, Critical Path Institute, Tucson, AZ.
9Division of Clinical Outcome Assessment, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
10Genentech, South San Francisco, CA, USA.
11Patient Experience Data & Strategy in Immunology and Oncology, Abbvie, North Chicago, IL, USA.
12Scientific and Regulatory Consulting, Aspen Consulting, LLC, Steamboat, CO, USA.
Abstract
Performance outcome (PerfO) assessments are standardized, task-based clinical outcome assessments (COAs) used to evaluate patients' physical, cognitive, sensory, and functional abilities in clinical trials. Building on the first ISPOR PerfO Task Force report, which addressed selection, development, and modification of PerfO instruments, this second task force report focuses on clinical trial imple…
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