CSRC Think Tank: CV Safety in Oncology Clinical Trials: Providing Clarity for a New Era of Cancer Therapeutics

December 1, 2021

Welcome and Introductions

Jonathan Seltzer, MD, MBA, MA (Executive Director, Cardiac Safety Research Consortium)

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Session 1: There is a problem with CV endpoints in oncology trials

  • Pros: Marc Bonaca, MD, MPH (CPC Clinical Research – University of Colorado)

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  • Cons: Leslie Lipka, MD, PhD (Merck & Co, Inc.)

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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)

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  • Over- and under-counting of CV events: experience of miscalculation of CV events in oncology trials– James Januzzi, Jr, MD (Harvard Medical)

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Session 3: Problems with Current Methods of Endpoint Capture

  • Problems with current methods of endpoint capture: Ninian Lang, MBChB, PhD (University of Glasgow, UK)

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