December 1, 2021
Welcome and Introductions
Jonathan Seltzer, MD, MBA, MA (Executive Director, Cardiac Safety Research Consortium)
Session 1: There is a problem with CV endpoints in oncology trials
- Pros: Marc Bonaca, MD, MPH (CPC Clinical Research – University of Colorado)
- Cons: Leslie Lipka, MD, PhD (Merck & Co, Inc.)
Session 2: Perspectives, CV endpoints in oncology trials
- Regulatory Perspective: Laleh Amiri-Kordestani, MD (US FDA)
No slides presented
- CTCAE Perspective: Alice Chen, MD (US NIH)
- Over- and under-counting of CV events: experience of miscalculation of CV events in oncology trials– James Januzzi, Jr, MD (Harvard Medical)
Session 3: Problems with Current Methods of Endpoint Capture
- Problems with current methods of endpoint capture: Ninian Lang, MBChB, PhD (University of Glasgow, UK)