The American Heart Association has called for standardized definitions of cardiovascular events that occur during clinical cancer trials, according to a scientific statement published June 15 in Circulation. The statement highlights how inconsistent definitions can be a barrier to understanding the cardiac risks associated with cancer therapies.
In the statement, researchers outlined standard definitions for adverse cardiovascular events such as heart failure, arrhythmias, myocarditis and thrombotic events.
Here are five things to know from the statement:
- Current clinical cancer trial designs inconsistently capture how and when cancer therapies cause cardiovascular toxicity.
- Researchers recommend that independent committees of cardiovascular experts be consulted in trials where cardiotoxicity is a safety concern.
- Decentralized and hybrid trial designs that use wearables and remote monitoring are addressed, with guidance on regulatory standards for data quality.
- Patient-reported outcomes should be collected alongside clinician-reported cardiovascular endpoints.
- The statement calls for closer collaboration between oncology and cardiology to improve cardiovascular safety evaluation without adding undue operational burden to trial design.
Read the full statement here.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
