June 15, 2026Circulation
Defining Cardiovascular Endpoints in Oncology Trials: Challenges and Opportunities: A Scientific Statement From the American Heart Association
Why the study?
Cardiovascular toxicities from cancer treatments affect patient outcomes, but evaluating safety signals in oncology trials has been limited by inconsistent definitions and variable approaches to event characterization.
Key Points
- This statement aims to establish clear definitions and frameworks for evaluating cardiovascular safety in cancer trials.
- Provides a framework for systematic selection and characterization of cardiovascular endpoints in oncology trials.
- Links drug-specific mechanisms to standardized definitions of adverse cardiovascular events.
- Suggests practical guidance for endpoint adjudication and statistical methods for analyzing risks and toxicities.
- Standardized definitions for adverse cardiovascular events including heart failure and thrombotic events.
- Enhanced alignment of cardiovascular endpoint assessment across oncology trials supports innovation in cancer therapeutics.
- Improved risk stratification and regulatory acceptance for cardiovascular safety in cancer treatment.
PICO
P
Population
Cardiovascular toxicities in cancer
I
Intervention / Comparator
Standardized cardiovascular endpoint definitions
This AHA scientific statement provides standardized definitions and practical guidance for assessing cardiovascular endpoints in oncology trials to enhance risk stratification and patient safety.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
“The statement provides a framework to enhance trial design, support regulatory decision-making, and ultimately improve care for patients receiving novel cancer therapies.”
Implication
May enhance CV endpoint consistency in oncology trials; leaves open effects on outcomes or regulatory decisions pending validation.
Abstract
The unprecedented expansion of approved oncology therapies has prolonged survival and transformed the prognosis for many patients diagnosed with cancer. However, cancer treatments may be associated with cardiovascular toxicities that manifest through vascular, myocardial, or metabolic pathways, potentially limiting the use of cancer therapeutics and adversely affecting outcomes. Oncology clinical trials provide an important opportunity to evaluate cardiovascular safety signals by generating data on the incidence, timing, and spectrum of toxicities. However, progress has been limited by inconsistent definitions and variable approaches to event characterization. This scientific statement aligns the advances in cardiovascular medicine and cardiovascular clinical trials to provide criteria for systematic selection, rigorous characterization, and adjudication of cardiovascular endpoints in contemporary oncology trials. The proposed framework links drug-specific mechanisms to endpoint selection and standardizes the approach to definitions of adverse cardiovascular events, including heart failure, arrhythmias, myocarditis, and thrombotic events. Definitions of major adverse cardiac events, clinical events, and surrogate endpoints are discussed, along with strategies for alignment with the Common Terminology Criteria for Adverse Events and patient-reported outcomes. Practical guidance is provided for prospective surveillance, decentralized and hybrid clinical trial designs, independent endpoint adjudication, and statistical approaches to competing risks and late-emerging toxicities. By harmonizing cardiovascular endpoint assessment across oncology trials, this scientific statement aims to enhance risk stratification, facilitate regulatory acceptance, and inform clinical decision-making, ultimately improving patient safety while supporting innovation in cancer therapeutics.
Discussion
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Cite This Study
Barac et al. (2026) conducted a review in Cardiovascular toxicities in cancer. Standardized cardiovascular endpoint definitions was evaluated. This AHA scientific statement provides a standardized framework for the systematic selection, characterization, and adjudication of cardiovascular endpoints in contemporary oncology clinical trials.