June 22, 2022 - June 23, 2022
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Patient Engagement in Medical-Product Research and Development (Virtual)
LEVEL: Introductory
TRACK: Patient Centered Research
LENGTH: 4 Hours | Course runs 2 consecutive days, 2 hours each day
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10:00AM–12:00PM Eastern Daylight Time (EDT)
14:00PM–16:00PM Coordinated Universal Time (UTC)
16:00PM–18:00PM Central European Time (CET)
Thursday, 23 June 2022 | Course runs 2 consecutive days
10:00AM–12:00PM Eastern Daylight Time (EDT)
14:00PM–16:00PM Coordinated Universal Time (UTC)
16:00PM–18:00PM Central European Time (CET)
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DESCRIPTION
Over the past decade, the role of patients as partners in medical-product development has increased. Add to that the development of Food and Drug Administration’s regulatory guidance for Patient-Focused Drug Development and the EMA’s patient input system, there is increasing an industry-wide focus on how to “collect information on the patient experience that is representative of the intended population to inform the development and evaluation of medical products throughout the medical product lifecycle.” Health economics and outcomes research (HEOR) stakeholders, including ISPOR members, are actively seeking to meaningfully partner with patients to incorporate patient-provided information and input into their research.
This half-day course is designed to provide participants with an introduction to patient engagement (PE) in medical-product research through defining PE and providing its historical context and significance throughout ISPOR’s HEOR taxonomy. This course will also equip attendees with tools to plan and implement meaningful PE activities in their respective areas of research expertise (eg, clinical development, epidemiology, health economics, real-world evidence, etc). The course will differentiate the skills needed for PE and who should be engaging versus methods for using patient experience data in research. There will be a session dedicated to addressing challenges in implementing PE in a clinical research environment. Real-world examples of patient-researcher partnerships will be presented to discuss best practices and demonstrate practical solutions to some of these challenges. One of the course’s strengths is that attendees will have the opportunity to interact with stakeholders who represent a variety of perspectives. Interaction with stakeholders and other attendees may also result in unique opportunities for further collaboration in PE medical-product research.
Elisabeth Oehrlein, PhD, MS
Founder & CEO
Applied Patient Experience, LLC
Washington, DC, USA
Robert McBurney, PhD
Chief Research Officer
Accelerated Cure Project for MS
Waltham, MA, USA
M. Suz Schrandt, JD
Founder & CEO
ExPPect
Arlington, VA, USA
Allison Martin Nguyen, MS
Senior Principal Scientist
Merck & Co
West Point, PA, USA
Basic Schedule:
Class Time: 2 hours daily