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FDA Public Workshop: Cardiovascular Toxicity Assessment in Oncology Trials

Organized by the:
U.S. Food & Drug Administration (FDA)
with support from the American Association for Cancer Research (AACR), American College of Cardiology (ACC), the American Heart Association (AHA) & American Society of Clinical Oncology (ASCO)

Co-Chairs: Dr. Laleh Amiri-Kordestani and Dr. Ana Barac

This Food and Drug Administration (FDA) public workshop will provide a forum for discussion of cardiovascular toxicity assessment within oncology clinical trials.  Cardiotoxicity is a well-established complication of oncology therapies. In the past decade, an explosion of novel cancer therapies, often targeted and more specific than conventional therapies, has revolutionized oncology therapy and dramatically changed cancer prognosis. However, some of these therapies have introduced an assortment of cardiovascular complications. At times, these devastating outcomes have only become apparent after drug approval and have limited the use of potent therapies. There is a growing need for better nonclinical testing platforms, imaging and serum biomarkers and trial designs; to screen, monitor and prevent these toxicities. The goals of this public workshop are to:

  • Discuss in vitro and in vivo nonclinical models to assess cardiovascular toxicity. 
  • Discuss best practices for identifying cardiovascular safety signals within oncology clinical trials. 
  • Discuss the role of imaging and biomarkers to predict and monitor cardiovascular toxicities.
  • Discuss what cardiovascular risk factors need to be captured at baseline and throughout the study.
  • Discuss how to improve the cardiovascular Adverse Events reporting within oncology clinical trials beyond CTCAE. 
  • Review the evidence available regarding implementation of cardiovascular prevention strategies.
  • Discuss how to design and implement cardiovascular safety registries.

Date: September 22, 2016

Time: 8:00 a.m. to 4:30 p.m.

Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 A (Great Room), Silver Spring, MD 20993

Webcast Information:

Meeting Information





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