AHA and ASCO Joint Statement Calls for Redefining Cardiovascular Endpoints in Oncology Trials
核心洞察
The American Heart Association and American Society of Clinical Oncology issued a joint scientific statement on defining cardiovascular endpoints in oncology trials, published in the Journal of Clinical Oncology and Circulation.
The statement provides a framework for asking cardiovascular safety questions before oncology trials begin, addressing a critical gap in current trial design.
Experts emphasize that traditional endpoints like MACE and mortality may slow innovation, while surrogate biomarkers such as MRD and ctDNA can accelerate decision-making.
A new joint scientific statement from the American Heart Association (AHA) and the American Society of Clinical Oncology (ASCO) is calling for a fundamental rethinking of how cardiovascular endpoints are defined and integrated into oncology clinical trials. Published simultaneously in the Journal of Clinical Oncology and Circulation, the statement outlines both the challenges and opportunities in capturing cardiovascular safety signals in cancer drug development.
The statement, authored by a multidisciplinary panel including Ana Barac, Avirup Guha, Thomas R. Fleming, Marc Bonaca, Paaladinesh Thavendiranathan, Anita Deswal, Laleh Amiri-Kordestani, Vishal Bhatnagar, Raul Cordoba, Sara Hurvitz, Alex A. Adjei, and Neeraj Agarwal, provides what the authors describe as "a framework for asking CV safety questions before trials begin."
Neeraj Agarwal, Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute, shared the publication on social media, emphasizing the importance of proactively addressing cardiovascular considerations in oncology research.
The Growing Need for Integrated Endpoints
The convergence of oncology and cardiovascular medicine has become increasingly important as cancer patients live longer and the cardiotoxic effects of many cancer therapies become more apparent. The AHA/ASCO statement arrives at a time when the clinical research community is grappling with a broader tension: the science of drug development is advancing faster than the frameworks used to evaluate it.
As Wael Harb, MD, Head of Research & Development in Early Phase Oncology at Syneos Health, noted in a related discussion on evolving clinical endpoints: "When a patient walks into a clinical trial, they are hoping to see their daughter graduate, go back to work sooner, or have the energy to live the life they came in hoping to keep, and yet, that's not what we measure."
Surrogate Endpoints Accelerating Decision-Making
In oncology, surrogate endpoints such as minimal residual disease (搜索) (MRD) are shortening the time required for clinical decision-making. Dr. Harb pointed to a landmark regulatory development: "The FDA's January 2026 MRD guidance in multiple myeloma (搜索) became a turning point in how we think about drug development. We can now decide on transformative therapy at 12 months instead of seven years. For a patient, that's not a regulatory detail; that's life."
Circulating tumor DNA (ctDNA) and MRD represent the kind of surrogate biomarkers that drug developers are increasingly relying upon to expedite evaluations while maintaining scientific rigor.
Cardiometabolic Endpoints Under Similar Pressure
The challenge is mirrored in cardiometabolic trials, where traditional foundational endpoints such as major adverse cardiovascular events (MACE) and mortality, while delivering rigor and credibility, come with significant burdens. Anup Sabharwal, MD, Vice President and Head of Research & Development and Scientific Strategy in Cardiometabolic at Syneos Health, explained: "There is a lot of focus on hard endpoints that have delivered rigor, credibility and meaningful impact. But they also come with time, scale and cost that can slow innovation."
This recognition is driving interest in alternative measures that better reflect meaningful patient outcomes, including days alive and out of hospital (DAOH) and quality-of-life adjusted outcomes.
Toward a Layered Endpoint Strategy
Looking ahead, experts suggest the next evolution of clinical endpoints will not involve replacing existing measures but rather layering them. This approach would incorporate a holistic view of the patient's experience, considering pain levels, emotional well-being, and functional independence alongside traditional clinical metrics.
The AHA/ASCO joint statement represents a significant step toward formalizing this integrated approach, particularly at the intersection of oncology and cardiovascular medicine, where the stakes for patient safety and treatment optimization are especially high.