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