RAPID - Phase III PAIINTERS
PAndemic Impact on INTERventional deviceS (PAIINTERS) Research Task Force
Peripheral Interventional Devices Team
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Michael R. Jaff, D.O.
Chief Medical Officer
Clinical Affairs, Technology and Innovation
Boston Scientific Corporation
Professor of Medicine, Harvard Medical School
Ajay J. Kirtane, M.D., S.M.
Professor of Medicine at the Columbia University Medical Center
Chief Academic Officer, Center for Interventional Vascular Therapy
Director, NYP/Columbia Cardiac Catheterization Laboratories
In conjunction with the National Evaluation System for health Technologies (NEST) RAPID Pathways Public-Private Partnership program, the PAndemic Impact on INTERventional deviceS (PAIINTERS) Research Task Force was launched in July 2020. This group represents a transparent, pre-competitive, collaborative forum for dialogue across stakeholders related to active and planned interventional device trials that were interrupted or otherwise affected by the pandemic from last spring reaching into the future as a public health emergency.
The first work item evolving from this group is a Use-Case Landscape of CAD and PAD regulatory, NIH and independent trials that were in planning, early enrollment, later enrollment, and completed enrollment in follow up when interrupted by the pandemic and, in many cases, where enrollment has resumed as the pandemic continues to wax and wane regionally and internationally.