ACC and AHA Issue New Clinical Data Standards on Cardiovascular Endpoint Events in Clinical Trials
The ACC and the American Heart Association, collaborating with the U.S. Food and Drug Administration (FDA) and the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), have released key data elements and definitions for cardiovascular endpoint events in clinical trials. The new document, published in the Journal of the American College of Cardiology, is designed to “provide a framework of data standards that would simplify the design and conduct of clinical trials for those considering regulatory submissions.”
The new terminology set includes cardiovascular endpoints of universal interest in clinical care, research, and regulatory review: death (specifically attribution of the cause of death), myocardial infarction, stroke, transient ischemic attack (TIA), coronary intervention (including stent thrombosis), peripheral vascular intervention, hospitalization for unstable angina and acute heart failure events. “These data standards are a first step in developing a universal language for clinical trials and other types of health-related research,” the authors said. However, they note that the intent of the document is not to be overly prescriptive. For example, they point out that stroke data elements included in the document are “minimal by design to allow for flexibility needed to conduct global clinical trials for drugs and devices.”
Moving forward, the authors acknowledge that the cardiovascular and stroke endpoint event concepts are a subset of a larger set of cardiovascular endpoints. Endpoint concepts related to carotid/cerebral revascularization, peripheral surgical revascularization and treatment of diseases of the aorta are beyond the scope of this current document and still remain to be developed.
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