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June 15, 2026Journal of Clinical Oncology
Defining Cardiovascular Endpoints in Oncology Trials: Challenges and Opportunities: A Scientific Statement From the American Heart Association
Why the study?
Cardiovascular safety evaluation in oncology clinical trials has been hindered by inconsistent definitions and variable approaches to cardiovascular event characterization.
Key Points
- This statement aims to standardize cardiovascular endpoint definitions and improve safety in oncology trials.
- Proposed a framework for cardiovascular endpoints linking drug mechanisms to event definitions.
- Discussed major adverse cardiac events and patient-reported outcomes.
- Provided guidance on independent endpoint adjudication and statistical approaches.
- Establishes criteria for systematic selection and rigorous characterization of cardiovascular endpoints.
- Improved risk stratification and facilitated regulatory acceptance of oncology therapies.
- Enhances clinical decision making to improve patient safety.
PICO
P
Population
Cardiovascular toxicities in oncology
Standardizing cardiovascular endpoint definitions in oncology trials will enhance risk stratification, facilitate regulatory acceptance, and improve patient safety.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The goal is to improve the consistency and interpretability of cardiovascular safety data without prescribing measures that unduly increase trial cost or operational complexity. Investigators and sponsors should balance scientific rigor with feasibility and prioritize evidence-based, low-burden approaches whenever high-quality data do not justify more intensive monitoring or data collection.”
EJEiman JahangirPhysician, cardiology (institution not specified)
“Great to see this published. Identifying cardiac endpoints in cancer trials is important as this field continues to grow. Additionally, identifying which endpoints warrant change to the cancer treatment will become important as we standardize these definitions and understand the outcomes more fully.”
Implication
Oncology trials warrant routine CV safety integration; leaves open optimal monitoring protocols for practice.
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.
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Cite This Study
Barac et al. (2026) conducted a review in Cardiovascular toxicities in oncology. This American Heart Association scientific statement provides a standardized framework for defining, selecting, and adjudicating cardiovascular endpoints in contemporary oncology clinical trials.