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Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It
Session Chair(s)
Elektra Papadopoulos, MD, MPH
Director, Patient Experience Data and Strategy
AbbVie, United States
Patient-focused clinical outcome assessments (COAs) are necessary for ensuring that the patient perspective is sufficiently incorporated into drug development decision-making. This session will cover regulatory, industry and instrument developer perspectives on how to efficiently and successfully design and implement patient-focused COAs as endpoints that are fit-for-purpose in drug development. FDA participant(s) will provide perspective on: 1) current initiatives (e.g., the COA Compendium, Critical Path Innovation Meetings, qualification partnerships, etc.) that can help facilitate the development and use of patient-focused COAs as endpoints in clinical trials; 2) best practices for interacting with the FDA; and 3) methods for engaging patients in COA endpoint development. An industry representative will offer perspective on recent patient-focused cultural shifts in industry and their impact on COA development and implementation in clinical trials. An Instrument developer will also discuss practical experiences in designing patient-focused COAs for use as endpoints in clinical trials.
Learning Objective : Describe the best practices for successfully developing and implementing patient-focused COA study endpoints that are fit-for-purpose for use in clinical trials.
Speaker(s)
Best Practices for Facilitating the Development and Use of Patient-Focused, Fit-For-Purpose COA Endpoints in Clinical Trials
Ebony Dashiell-Aje, PhD
BioMarin, United States
Executive Director and Head, Patient Centered Outcomes Science
Industry Initiatives: Cultural Shifts Impacting COA Development and Implementation in Clinical Trials
Lisa A Kammerman, PhD, MS
Kammerman Consulting, LLC, United States
Regulatory Statistics and PRO Consultant
Practical Experiences in Designing Patient-Focused COAs for Use as Endpoints in Clinical Trials: An Instrument Developer’s Perspective
Chad Gwaltney, PhD
Gwaltney Consulting, United States
President
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