Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel.
Publication/Presentation Date
12-1-2022
Abstract
The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of Health, payers, and industry. Members discussed the measure, remote capture, and clinical utility of functional and quality-of-life endpoints for use in clinical trials of heart failure and cardiovascular therapeutics, with the goal of improving the efficiency of heart failure and cardiovascular clinical research, evidence generation, and thereby patient quality of life, functional status, and survival. Assessments of patient-reported outcomes and maximal and submaximal exercise tolerance are standardized and validated, but actigraphy remains inconsistent as a potential endpoint. This paper details those discussions and consensus recommendations.
Volume
10
Issue
12
First Page
889
Last Page
901
ISSN
2213-1787
Published In/Presented At
Psotka, M. A., Abraham, W. T., Fiuzat, M., Filippatos, G., Lindenfeld, J., Ahmad, T., Felker, G. M., Jacob, R., Kitzman, D. W., Leifer, E. S., Lewis, E. F., Mentz, R. J., Nkulikiyinka, R., Ni, W., Schaber, D. E., Sharma, A., Solomon, S. D., Stockbridge, N., Teerlink, J. R., Unger, E. F., … O'Connor, C. M. (2022). Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel. JACC. Heart failure, 10(12), 889–901. https://doi.org/10.1016/j.jchf.2022.09.012
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
36456063
Department(s)
Administration and Leadership
Document Type
Article