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

ABSTRACT: The development of novel treatments has improved cancer outcomes but may result in cardiovascular toxicities. Traditional approaches to clinical trial safety evaluation have limitations in their ability to detect signals of cardiovascular risk. Mechanisms to increase power and specificity to clarify cardiovascular safety are required. However, implications include increased costs and slower development. The Cardiovascular Safety Research Consortium facilitated stakeholder discussions with representation from academia, industry, and regulators. A think tank was assembled with the aim of providing recommendations for improved collection and reporting of cardiovascular safety signals in oncology trials. Two working groups were formed. The first focuses on incorporation of consensus definition

SUBMITTER: Bonaca MP 

PROVIDER: S-EPMC11866450 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature