The American College of Cardiology and the American Heart Association have released clinical data standards for cardiovascular and endpoints in clinical trials.
The document, which was developed in collaboration with the US Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative, is the first step in developing a universal language to uniformly capture clinical event information across all types of clinical trials and other research and clinical evaluations. The data standards will facilitate the conduct of pooled analyses and meta-analyses to evaluate safety and effectiveness in clinical trials. These data standards may also be used in clinical care processes, registries, electronic health records, longitudinal drug or device surveillance, and other types of health-related research to capture key cardiovascular outcomes. This unique collaboration acknowledges the need to align key clinical concepts for regulatory reporting and key concepts for clinical care.
The 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials will publish in full on the websites for the ACC (www.cardiosource.org) and AHA (www.heart.org) and will appear in upcoming print editions of Journal of the American College of Cardiology and Circulation.