Defining Cardiovascular Endpoints in Oncology Trials: Challenges and Opportunities
Updated: June 15, 2026
- Cancer therapies can carry meaningful cardiovascular (CV) risks. Oncology trials play an important role in identifying, defining, and interpreting CV effects alongside anticancer benefit.
- This statement outlines a standardized framework for CV endpoints, including clear definitions, adjudication, baseline testing, surveillance, and the use of biomarkers and patient-reported outcomes.
- Its broader aim is to make oncology trials more consistent, clinically relevant, and regulator-ready, while strengthening collaboration between oncology and cardiology to better assess net clinical benefit.
Message from the Chairs
In this video, Writing Group Chair Ana Barac, MD, PhD, FAHA and Vice Chair Avirup Guha, MD, FAHA discuss the multidisciplinary effort behind the new statement, including contributions from cardio-oncology experts, clinical trialists, statisticians, and the U.S. Food and Drug Administration, and emphasize alignment with regulatory and oncology communities and support from the American Society of Clinical Oncology (ASCO). The statement provides a framework to enhance trial design, support regulatory decision-making, and ultimately improve care for patients receiving novel cancer therapies.