Real-World Evidence for Medical Devices: An Interim Report on Lessons from the NESTcc Test-Cases

The National Evaluation System for health Technology Coordinating Center (NESTcc) pilot projects, or Test-Cases, represent one of the largest initiatives undertaken to systematically assess the potential for real-world data (RWD) to support regulatory decision-making.

As part of its MDUFA IV commitments, NESTcc contracted with The RAND Corporation (RAND) to develop an independent assessment of the Test-Cases to evaluate the strengths, limitations and use of real-world evidence (RWE) for regulatory decision-making. RAND produced an interim report on 14 of the Test-Cases, which highlighted promising methods to generate RWE, as well as challenges and opportunities to continue advancing the use of RWD in device evaluation.

In this webinar, experts from NESTcc, RAND, and Test-Case project teams shared:

• Keys to success in generating evidence from diverse data sources for medical devices
• Opportunities to use real-world data in the evaluation of devices across therapeutic areas and device types
• Lessons to leverage and challenges to address for stakeholder efforts in generating evidence for regulatory decision-making

Webinar Speakers

• Sandra Siami, MPH, Senior Vice President, NESTcc/MDIC
• Justin W. Timbie, Ph.D., Senior Health Policy Researcher, The RAND Corporation
• Adrian Hernandez, M.D., MHS, Professor of Medicine at Duke School of Medicine, Vice Dean and Executive Director of the Duke Clinical Research Institute (DCRI), NESTcc Governing Committee Chair
• Paul Coplan, ScD, MBA, MPH, Vice President and Global Head of Medical Device Epidemiology and Real-World Data Sciences, Johnson & Johnson
• Joseph Ross, M.D., MHS, Professor of Medicine and of Public Health, Yale School of Medicine
• Art Sedrakyan, M.D., Ph.D., Professor of Population Health Sciences, Weill Cornell Medicine; Director, Institute for Health Technologies and Interventions and MDEpiNet