Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer (JACC: CardioOncology State-of-the-Art Review February 2025)-Article: Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer

Article: Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer

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The article "Cardiovascular Safety in Oncology Clinical Trials" by Bonaca et al. addresses the growing concern of cardiovascular complications arising from cancer therapies. With advancements in cancer treatments, cardiovascular toxicities have surfaced as a significant side effect, necessitating a systematic approach to assess their safety during clinical trials. The American College of Cardiology through its JACC: CardioOncology initiative hosted a think tank involving leading experts from academia, the pharmaceutical industry, and regulatory agencies such as the FDA.<br /><br />The think tank aimed to enhance the identification and reporting of cardiovascular events in cancer clinical trials by establishing two working groups. The first group focused on integrating standardized definitions of cardiovascular diseases into the Common Terminology Criteria for Adverse Events (CTCAE) used in oncology. The second group examined methods for better ascertainment and adjudication of cardiovascular events.<br /><br />The necessity for increased collaboration in trial design is highlighted, particularly by incorporating cardiology input and refining data collection methods. Traditional safety evaluations like CTCAE, while comprehensive, face challenges such as overlapping terms and lack specificity in cardiovascular event characterization. Thus, the importance of innovative trial designs that include more diverse patient populations and robust post-marketing surveillance is stressed.<br /><br />These efforts reflect a broader objective to safeguard patients by ensuring cardiovascular risks are more accurately recognized and managed in the context of cancer treatment advancements. The consensus is that a tailored, collaborative, strategic approach is essential to improve cardiovascular safety, potentially involving endpoint adjudication and enhanced consultation with cardiology specialists.<br /><br />The article underscores the critical nature of shifting trial designs to encapsulate these new dynamics, ensuring the well-being of long-term cancer survivors who may face compounded cardiovascular risks.

Keywords

Cardiovascular Safety

Oncology Clinical Trials

Cancer Therapies

Cardiovascular Toxicities

JACC: CardioOncology

Adverse Events

Clinical Trial Design

Cardiology Collaboration

Endpoint Adjudication

Post-marketing Surveillance