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Monday, June 28 • 1:00pm - 2:00pm
#112 SL: Measuring Clinically Meaningful Change of Function: A Case Study of Patient-Centered Clinical Outcome Assessments in Early Parkinson’s Disease

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-532-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Thomas Morel, DrSc

Speaker

Panelist
Karlin Schroeder, MA

Panelist
Michelle Campbell, PhD

Panelist
Roger Barker, MD, PhD



Speakers
avatar for Thomas Morel

Thomas Morel

Director, Patient-Centred Outcomes Research, UCB Biopharma, Belgium
Thomas Morel (DrSc) is Director for Patient-Centred Outcomes Research, Global Clinical Development at UCB. Through his role, Thomas ensures that the patient perspective is at the very heart of drug development by promoting the use in clinical trials of PROs and of clinical outcome... Read More →
RB

Roger Barker

Professor, Department of Clinical Neurosciences, Cambridge University, United Kingdom
Roger Barker is the Professor of Clinical Neuroscience at the University of Cambridge and Consultant Neurologist at the Addenbrooke’s Hospital Cambridge. He is a PI in the MRC-Wellcome Trust Stem Cell Institute in Cambridge and Director of the MRC funded UKRMP Stem and Engineered... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
avatar for Karlin Schroeder

Karlin Schroeder

Associate Vice President, Community Engagement, Parkinson's Foundation, United States
Karlin Schroeder, M.A., is the Associate Vice President of Community Engagement at the Parkinson’s Foundation, where she leads the Research Advocacy program. Through this program, Karlin creates and directs projects to incorporate patient expertise into research design and implementation... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum
  • Beginner Intermediate
  • Featured Topics Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Patient Focused,Patient Focused
  • Featured Topics Patient Focused,Patient Focused
  • Tags Forum