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Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.
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.
  • Psotka MA; Inova Heart and Vascular Institute, Falls Church, Virginia. Electronic address: https://twitter.com/mpsotka.
  • Abraham WT; Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. Electronic address: William.Abraham@osumc.edu.
  • Fiuzat M; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina. Electronic address: https://twitter.com/mfiuzat.
  • Filippatos G; University of Cyprus Medical School, Shakolas Educational Center for Clinical Medicine, Nicosia, Cyprus.
  • Lindenfeld J; Heart Failure and Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.
  • Ahmad T; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.
  • Bhatt AS; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Carson PE; Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC.
  • Cleland JGF; Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.
  • Felker GM; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.
  • Januzzi JL; Cardiology Division, Massachusetts General Hospital and Baim Institute for Clinical Research, Boston, Massachusetts.
  • Kitzman DW; Sections on Cardiovascular Medicine and Geriatrics, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
  • Leifer ES; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.
  • Lewis EF; Division of Cardiovascular Medicine, Stanford University, Palo Alto, California.
  • McMurray JJV; BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
  • Mentz RJ; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.
  • Solomon SD; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Stockbridge N; United States Food and Drug Administration, Silver Spring, Maryland.
  • Teerlink JR; Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California-San Francisco, San Francisco, California. Electronic address: https://twitter.com/jteerlinkmd.
  • Vaduganathan M; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Vardeny O; Pharmacy Practice Division, Minneapolis VA Center for Care Delivery and Outcomes Research and University of Minnesota, Minneapolis, Minnesota.
  • Whellan DJ; Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania.
  • Wittes J; Statistics Collaborative, Washington, DC.
  • Anker SD; Division of Cardiology and Metabolism, Department of Cardiology, Berlin-Brandenburg Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.
  • O'Connor CM; Inova Heart and Vascular Institute, Falls Church, Virginia; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina. Electronic address: https://twitter.com/coconnormd.
J Am Coll Cardiol ; 76(20): 2368-2378, 2020 11 17.
Article in English | MEDLINE | ID: covidwho-912306
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Clinical Trials as Topic / Coronavirus Infections / Pandemics Type of study: Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Am Coll Cardiol Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Clinical Trials as Topic / Coronavirus Infections / Pandemics Type of study: Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Am Coll Cardiol Year: 2020 Document Type: Article