Consensus recommendations for populations and endpoint definitions were established by the Heart Failure Academic Research Consortium to stimulate heart failure clinical trial innovation.
The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation.
Abraham et al. (Mon,) conducted a review in Heart failure. Standardized definitions for evaluation of heart failure therapies was evaluated. Consensus recommendations for populations and endpoint definitions were established by the Heart Failure Academic Research Consortium to stimulate heart failure clinical trial innovation.