“What makes this work unique is that it reviews and refines the terms as developed by the SCTI explicitly for use in reporting clinical trial results and in regulatory submissions, and it delineates where these concepts could or should not be used as the foundational vocabulary in routine clinical care,” Dr. Hicks, a cardiologist at the FDA, and her associates stated.
The SCTI is a working group comprised of experts from academia, professional societies, the FDA, and manufacturers of pharmaceuticals and CV devices. The ACC/AHA task force included 16 people with expertise in internal medicine, cardiovascular medicine, neurology, clinical research, epidemiology, invasive and interventional therapies, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.
The full report is available from the American College of Cardiology at www.acc.org and from the American Heart Association at www.myamericanheart.org.
This work received no commercial support. Dr. Hicks and her associates volunteered their time and were supported exclusively by the ACC and AHA.