RAPID - Phase III Collaborative PTX
Dr. Kenneth Rosenfield, Multi-Specialty Coalition on Paclitaxel (Chair)
Dr. Sara Royce, U. S. Food and Drug Administration (Co-Chair)
Dr. Andrew Farb, U. S. Food and Drug Administration (Co-Chair)
Dr. Aaron Lottes, Cook Medical (Co-Chair)
Rebecca Wilgus, MSN Duke Clinical Research Institute (Project Leader)
This workgroup will share collective knowledge regarding industry-sponsored and independently conducted studies of peripheral paclitaxel (PTX) devices, will examine the landscape of ongoing studies and determine when new meaningful data will become available. This information will be used to inform the reevaluation of global PTX data by the US FDA and other stakeholders. Lessons learned and gaps in data will be identified, and recommendations for future trials, including design, conduct, and data analysis, will be shared. The workgroup will publish a comprehensive white paper focused on a lessons learned from paclitaxel research.