RAPID - Phase III ANSWER Task Force

Leadership Team

Roseann White, Syntactx (Co-Chair)

Eleni Whatley, PhD  U.S. Food and Drug Administration (Co-Chair)

Rebecca Wilgus, MSN Duke Clinical Research Institute (Project Leader)

Work Product 

Members from the Collaborative PTX Project Work Group and the SANEST Work Group collaborate with the Paclitaxel Pan-Industry Collaboration to develop a statistical analysis plan to re-evaluate the PTX safety signal identified in December 2018.  The re-analysis will estimate mortality and TLR, as well as various sensitivity analyses, in observational and real-world datasets and single arm studies.    

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