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Patient Engagement and NEST: Lessons Learned and Best Practices
Fadia T. Shaya, PhD, MPH and Frank B. Palumbo, PhD, JD
University of Maryland Baltimore Center on Drugs and Public Policy, School of Pharmacy, Pharmaceutical Health Services Department
Gregory Pappas, MD, PhD, and Lisa Miller, PhD
Center for Devices and Radiological Health (CDRH) Food and Drug Administration
Meeting Objectives: This meeting will engage a variety of patient and patient groups related to the device ecosystem. An objective of NEST is to fully engage patients in its development and function in all aspects. The workshop will gather lessons learned and best practices for patient engagement in evidence generation (planning, collection of data and information, analysis, and dissemination). The workshop should stimulate discussion on the best practices and lessons learned for NEST to more fully engage patients
Meeting Outcomes/deliverables: The workshop should document, as presented by the speakers, existing best practices and lessons learned of how patients are engaged with real world evidence generation for medical device or device and drug combination evaluation. The workshop speakers should identify evidence gaps for future investigation. The workshop will also document the best practices and lessons learned for patient engagement in the production and use of real world evidence (RWE) that will facilitate future work in this area. Lessons learned and best practices will be drawn together into a proceedings document from this workshop.
|7:30-8:30||Registration, Coffee and light breakfast|
|8:30-9:30||Session 1 – Framing the Challenge||
|9:30-10:00||Session 2 – Keynote|
|10:30-11:30||Session 3 – Building the Infrastructure||
|11:30-12:30||Session 4 – Best Practices||
|12:30-1:30||Lunch||Table exhibits, invitations will be sent to patient groups offering them a table.|
Afternoon concurrent breakout sessions
Small groups will work in parallel, to bring together best practices and lessons learned for patient engagement to develop and use of RWE in NEST.
|Breakout session 1: Cardiology||Moderator: Ms. Kathleen Hewitt, ACC (accepted)|
|Breakout session 2: Orthopedics||Moderator: TBA|
|Breakout session 3: Women’s health||Moderator: Dr. Danica Marinac-Dabic, FDA/CDRH|