Journal of the American College of Cardiology · 2020
Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.
Consensus StatementСтатьяОбзорНазвание и аннотация: Перевод пока не подготовлен
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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, O'Connor Christopher M
Аннотация
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.