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DIA 2021 Global Annual Meeting
Measuring Clinically Meaningful Change of Function: A Case Study of Patient-Centered Clinical Outcome Assessments in Early Parkinson’s Disease
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.
Karlin Schroeder, MA
- Associate Vice President, Community Engagement
- Parkinson's Foundation, United States
Michelle Campbell, PhD
- Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
- FDA, United States
Roger Barker, MD, PhD
- Professor, Department of Clinical Neurosciences
- Cambridge University, United Kingdom