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Measuring Clinically Meaningful Change of Function: A Case Study of Patient-Centered Clinical Outcome Assessments in Early Parkinson’s Disease
Session Chair(s)
Thomas Morel, DrSc
Director, Patient-Centred Outcomes Research
UCB Biopharma, Belgium
The FDA has been encouraging patient-focused drug development and, as part of that, incorporating patients into the development of clinical outcomes assessments (COAs) to ensure that they are meaningful to patients and appropriate to measure treatment benefit.
Outcome assessments used in clinical trials need to fit the needs of multiple stakeholders; it is beneficial to engage with multiple stakeholders throughout the development/modification of COAs.
Panelists will discuss the need for patient-centred measures to capture a clinically meaningful effect of an intervention in the context of early Parkinson's disease.
Learning Objective : Describe how to better incorporate patient viewpoints into both legacy clinical outcome assessment (COA) measures and novel instruments (with the case of early Parkinson's disease as illustration); Define more informed COA strategies based on FDA's current thinking and approach; Discuss the state FDA’s PFDD program.
Speaker(s)
Panelist
Karlin Schroeder, MA
Parkinson's Foundation, United States
Associate Vice President, Community Engagement
Panelist
Michelle Campbell, PhD
FDA, United States
Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER
Panelist
Roger Barker, MD, PhD
Cambridge University, United Kingdom
Professor, Department of Clinical Neurosciences
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