RAPID - Phase II Protocol Development

Co-chairs​

  • Daniel Bertges, MD & Jack Cronenwett, MD University of Vermont & Society of Vascular Surgery, Vascular Quality Initiative

  • Mitchell Krucoff, MD Duke University

  • Aaron Lottes, PhD Cook Medical

  • Misti Malone, PhD, US Food and Drug Administration

  • Melanie Raska, Boston Scientific

 

Members of the Protocol Development working group are developing research proposals to demonstrate use of patient-level data for the RAPID core data elements extracted from RAPID data partners and used to support regulatory applications.

 

Key responsibilities

  • Develop statistical analysis plan (SAP) for the SPEED Objective Performance Goal

  • Define covariates and endpoints for SPEED

  • Identify variables from RAPID data partner to support the SPEED SAP

  • Provide leadership and support for the data transfer and analysis for the SPEED OPC

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