December 29, 2014 — The American College of Cardiology and the American Heart Association released clinical data standards for cardiovascular and endpoints in clinical trials.
The document, which was developed in collaboration with the U.S. Food and Drug Administration (FDA) and the Standardized Data Collection for Cardiovascular Trials Initiative, is the first step in developing a universal language to 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 collaboration acknowledges the need to align clinical concepts for regulatory reporting and concepts for clinical care.
For more information: www.cardiosource.org/ACC, www.heart.org