RAPID - Phase III ANSWER Task Force
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)
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.