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Sunday, June 24 • 1:00pm - 4:30pm
#35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban

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Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-18-511-L04-P; CME 3.25; IACET 3.25; RN 3.25

In this case study the audience will serve as the CDER Cardiorenal Advisory Committee voting on the same questions as on September 2011 (Rivaroxaban for stroke prevention in atrial fibrillation). The case study will follow the following sequence: CDER Advisory Committee structure and function relative to CDER decisions, rivaroxaban pivotal trial summary (Rocket AF), critical video clips from the advisory committee impacting your vote, biostatistics analysis discussion, your vote, and post advisory committee history including realizing the portable device used to measure INR malfunctioned. Particular focal areas in the case will include issues around dose-response, regional heterogeneity in results, and best practices for device use in pivotal clinical trials. General principles on trial design, analysis and interpretation will be illustrated through topic specific video play and interactive in-class discussion. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for individuals who work in regulatory affairs, clinical development, biostatistics, trial monitoring, clinical investigators, exploratory development, and regulatory agencies.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Evaluate the CDER Advisory Committee value in regulatory decisions
  • Describe the particular concerns regarding pivotal non-inferiority, multi-regional global trial design
  • Analyze the impact of biomarker device performance on pivotal clinical trials



Speakers
RP

Robert Powell

Clinical Pharmacologist, University of North Carolina
Bob Powell, Pharm.D. is a clinical pharmacologist working on precision drug dosing research as an adjunct professor at the University of North Carolina Chapel Hill College of pharmacy. He also teaches drug development principles at the Peking University Clinial Research Institute... Read More →
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →
avatar for Stephen Wilson

Stephen Wilson

Statistical Consultant
Statistical reviewer/manager at FDA/CDER for more than 30 years; Captain in the USPHS; Retired as Dir. of Div. of Biometrics III/Office of Biostatistics on June 1, 2017; Received a doctorate in Biostatistics from UNC Chapel Hill in 1984; Also worked for the East West Center, the Indonesian... Read More →


Sunday June 24, 2018 1:00pm - 4:30pm
Room 162A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA