Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.

Authors

• Mitchell A. Psotka, Inova Heart and Vascular Institute
• William T. Abraham, The Ohio State University
• Mona Fiuzat, Duke University Medical Center and Duke Clinical Research Institute
• Gerasimos Filippatos, University of Cyprus Medical School
• JoAnn Lindenfeld, Vanderbilt Heart and Vascular Institute
• Tariq Ahmad, Yale University School of Medicine
• Ankeet S. Bhatt, Brigham and Women's Hospital
• Peter E. Carson, Washington Veterans Affairs Medical Center
• John G.F. Cleland, University of Glasgow
• G. Michael Felker, Duke University Medical Center and Duke Clinical Research Institute
• James L. Januzzi, Massachusetts General Hospital and Baim Institute for Clinical Research
• Dalane W. Kitzman, Wake Forest School of Medicine
• Eric S. Leifer, National Heart, Lung, and Blood Institute
• Eldrin F. Lewis, Stanford University
• John J.V. McMurray, University of Glasgow
• Robert J. Mentz, Duke University Medical Center and Duke Clinical Research Institute
• Scott D. Solomon, Brigham and Women's Hospital
• Norman Stockbridge, United States Food and Drug Administration
• John R. Teerlink, University of California-San Francisco
• Muthiah Vaduganathan, Brigham and Women's Hospital
• Orly Vardeny, Minneapolis VA Center for Care Delivery and Outcomes Research and University of Minnesota
• David J. Whellan, Thomas Jefferson UniversityFollow
• Janet Wittes, Statistics Collaborative, Washington, DC
• Stefan D. Anker, Charité Universitätsmedizin Berlin
• Christopher M. O'Connor, Inova Heart and Vascular Institute; Duke University Medical Center and Duke Clinical Research Institute

Document Type

Article

Publication Date

11-17-2020

Comments

This article is the author’s final published version in Journal of the American College of Cardiology, Volume 76, Issue 20, November 2020, Pages 2368-2378.

The published version is available at https://doi.org/10.1016/j.jacc.2020.09.544. Copyright © Psotka et al.

Abstract

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.

Recommended Citation

Psotka, Mitchell A.; Abraham, William T.; Fiuzat, Mona; Filippatos, Gerasimos; Lindenfeld, JoAnn; Ahmad, Tariq; Bhatt, Ankeet S.; Carson, Peter E.; Cleland, John G.F.; Felker, G. Michael; Januzzi, James L.; Kitzman, Dalane W.; Leifer, Eric S.; Lewis, Eldrin F.; McMurray, John J.V.; Mentz, Robert J.; Solomon, Scott D.; Stockbridge, Norman; Teerlink, John R.; Vaduganathan, Muthiah; Vardeny, Orly; Whellan, David J.; Wittes, Janet; Anker, Stefan D.; and O'Connor, Christopher M., "Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel." (2020). Department of Medicine Faculty Papers. Paper 281.
https://jdc.jefferson.edu/medfp/281

Creative Commons License

This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

PubMed ID

33183511

Language

English