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

Identifieur interne : 000191 ( Main/Exploration ); précédent : 000190; suivant : 000192

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

Auteurs : Mitchell A. Psotka [États-Unis] ; William T. Abraham [États-Unis] ; Mona Fiuzat [États-Unis] ; Gerasimos Filippatos [Chypre (pays)] ; Joann Lindenfeld [États-Unis] ; Tariq Ahmad [États-Unis] ; Ankeet S. Bhatt [États-Unis] ; Peter E. Carson [États-Unis] ; John G F. Cleland [Royaume-Uni] ; G Michael Felker [États-Unis] ; James L. Januzzi [États-Unis] ; Dalane W. Kitzman [États-Unis] ; Eric S. Leifer [États-Unis] ; Eldrin F. Lewis [États-Unis] ; John J V. Mcmurray [Royaume-Uni] ; Robert J. Mentz [États-Unis] ; Scott D. Solomon [États-Unis] ; Norman Stockbridge [États-Unis] ; John R. Teerlink [États-Unis] ; Muthiah Vaduganathan [États-Unis] ; Orly Vardeny [États-Unis] ; David J. Whellan [États-Unis] ; Janet Wittes [États-Unis] ; Stefan D. Anker [Allemagne] ; Christopher M. O'Connor [États-Unis]

Source :

RBID : pubmed:33183511

Descripteurs français

English descriptors

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.

DOI: 10.1016/j.jacc.2020.09.544
PubMed: 33183511


Affiliations:


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Le document en format XML

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<name sortKey="Bhatt, Ankeet S" sort="Bhatt, Ankeet S" uniqKey="Bhatt A" first="Ankeet S" last="Bhatt">Ankeet S. Bhatt</name>
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<region type="state">Massachusetts</region>
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<name sortKey="Carson, Peter E" sort="Carson, Peter E" uniqKey="Carson P" first="Peter E" last="Carson">Peter E. Carson</name>
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<region type="state">District de Columbia</region>
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<name sortKey="Cleland, John G F" sort="Cleland, John G F" uniqKey="Cleland J" first="John G F" last="Cleland">John G F. Cleland</name>
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<name sortKey="Felker, G Michael" sort="Felker, G Michael" uniqKey="Felker G" first="G Michael" last="Felker">G Michael Felker</name>
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<region type="state">Caroline du Nord</region>
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<name sortKey="Januzzi, James L" sort="Januzzi, James L" uniqKey="Januzzi J" first="James L" last="Januzzi">James L. Januzzi</name>
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<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
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<name sortKey="Kitzman, Dalane W" sort="Kitzman, Dalane W" uniqKey="Kitzman D" first="Dalane W" last="Kitzman">Dalane W. Kitzman</name>
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<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Caroline du Nord</region>
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<region type="state">Maryland</region>
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<name sortKey="Lewis, Eldrin F" sort="Lewis, Eldrin F" uniqKey="Lewis E" first="Eldrin F" last="Lewis">Eldrin F. Lewis</name>
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<region type="state">Californie</region>
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<wicri:cityArea>Division of Cardiovascular Medicine, Stanford University, Palo Alto</wicri:cityArea>
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<name sortKey="Mentz, Robert J" sort="Mentz, Robert J" uniqKey="Mentz R" first="Robert J" last="Mentz">Robert J. Mentz</name>
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<nlm:affiliation>Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Duke University Medical Center and Duke Clinical Research Institute, Durham</wicri:cityArea>
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<name sortKey="Solomon, Scott D" sort="Solomon, Scott D" uniqKey="Solomon S" first="Scott D" last="Solomon">Scott D. Solomon</name>
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<nlm:affiliation>Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Cardiovascular Division, Brigham and Women's Hospital, Boston</wicri:cityArea>
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<name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name>
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<nlm:affiliation>United States Food and Drug Administration, Silver Spring, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Maryland</region>
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<wicri:cityArea>United States Food and Drug Administration, Silver Spring</wicri:cityArea>
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<name sortKey="Teerlink, John R" sort="Teerlink, John R" uniqKey="Teerlink J" first="John R" last="Teerlink">John R. Teerlink</name>
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<nlm:affiliation>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.</nlm:affiliation>
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<wicri:cityArea>Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California-San Francisco, San Francisco</wicri:cityArea>
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<name sortKey="Vaduganathan, Muthiah" sort="Vaduganathan, Muthiah" uniqKey="Vaduganathan M" first="Muthiah" last="Vaduganathan">Muthiah Vaduganathan</name>
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<nlm:affiliation>Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
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<name sortKey="Vardeny, Orly" sort="Vardeny, Orly" uniqKey="Vardeny O" first="Orly" last="Vardeny">Orly Vardeny</name>
<affiliation wicri:level="2">
<nlm:affiliation>Pharmacy Practice Division, Minneapolis VA Center for Care Delivery and Outcomes Research and University of Minnesota, Minneapolis, Minnesota.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
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<name sortKey="Whellan, David J" sort="Whellan, David J" uniqKey="Whellan D" first="David J" last="Whellan">David J. Whellan</name>
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<nlm:affiliation>Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Department of Medicine, Thomas Jefferson University, Philadelphia</wicri:cityArea>
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<name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name>
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<nlm:affiliation>Statistics Collaborative, Washington, DC.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">District de Columbia</region>
</placeName>
<wicri:cityArea>Statistics Collaborative, Washington</wicri:cityArea>
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<name sortKey="Anker, Stefan D" sort="Anker, Stefan D" uniqKey="Anker S" first="Stefan D" last="Anker">Stefan D. Anker</name>
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<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>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</wicri:regionArea>
<placeName>
<region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
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<name sortKey="O Connor, Christopher M" sort="O Connor, Christopher M" uniqKey="O Connor C" first="Christopher M" last="O'Connor">Christopher M. O'Connor</name>
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<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Inova Heart and Vascular Institute, Falls Church, Virginia; Duke University Medical Center and Duke Clinical Research Institute, Durham</wicri:cityArea>
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<name sortKey="Fiuzat, Mona" sort="Fiuzat, Mona" uniqKey="Fiuzat M" first="Mona" last="Fiuzat">Mona Fiuzat</name>
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<country xml:lang="fr">États-Unis</country>
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<region type="state">Caroline du Nord</region>
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<name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name>
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<name sortKey="Lindenfeld, Joann" sort="Lindenfeld, Joann" uniqKey="Lindenfeld J" first="Joann" last="Lindenfeld">Joann Lindenfeld</name>
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<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Tennessee</region>
</placeName>
<wicri:cityArea>Heart Failure and Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville</wicri:cityArea>
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<name sortKey="Ahmad, Tariq" sort="Ahmad, Tariq" uniqKey="Ahmad T" first="Tariq" last="Ahmad">Tariq Ahmad</name>
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<nlm:affiliation>Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven</wicri:cityArea>
</affiliation>
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<author>
<name sortKey="Bhatt, Ankeet S" sort="Bhatt, Ankeet S" uniqKey="Bhatt A" first="Ankeet S" last="Bhatt">Ankeet S. Bhatt</name>
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<nlm:affiliation>Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Cardiovascular Division, Brigham and Women's Hospital, Boston</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Carson, Peter E" sort="Carson, Peter E" uniqKey="Carson P" first="Peter E" last="Carson">Peter E. Carson</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">District de Columbia</region>
</placeName>
<wicri:cityArea>Department of Cardiology, Washington Veterans Affairs Medical Center, Washington</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Cleland, John G F" sort="Cleland, John G F" uniqKey="Cleland J" first="John G F" last="Cleland">John G F. Cleland</name>
<affiliation wicri:level="4">
<nlm:affiliation>Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow</wicri:regionArea>
<orgName type="university">Université de Glasgow</orgName>
<placeName>
<settlement type="city">Glasgow</settlement>
<region type="country">Écosse</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Felker, G Michael" sort="Felker, G Michael" uniqKey="Felker G" first="G Michael" last="Felker">G Michael Felker</name>
<affiliation wicri:level="2">
<nlm:affiliation>Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Duke University Medical Center and Duke Clinical Research Institute, Durham</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Januzzi, James L" sort="Januzzi, James L" uniqKey="Januzzi J" first="James L" last="Januzzi">James L. Januzzi</name>
<affiliation wicri:level="2">
<nlm:affiliation>Cardiology Division, Massachusetts General Hospital and Baim Institute for Clinical Research, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Cardiology Division, Massachusetts General Hospital and Baim Institute for Clinical Research, Boston</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Kitzman, Dalane W" sort="Kitzman, Dalane W" uniqKey="Kitzman D" first="Dalane W" last="Kitzman">Dalane W. Kitzman</name>
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<region type="state">Maryland</region>
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<region type="state">Californie</region>
</placeName>
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<nlm:affiliation>Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.</nlm:affiliation>
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<placeName>
<region type="state">Caroline du Nord</region>
</placeName>
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<name sortKey="Solomon, Scott D" sort="Solomon, Scott D" uniqKey="Solomon S" first="Scott D" last="Solomon">Scott D. Solomon</name>
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<region type="state">Massachusetts</region>
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<name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name>
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<region type="state">Maryland</region>
</placeName>
<wicri:cityArea>United States Food and Drug Administration, Silver Spring</wicri:cityArea>
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<author>
<name sortKey="Teerlink, John R" sort="Teerlink, John R" uniqKey="Teerlink J" first="John R" last="Teerlink">John R. Teerlink</name>
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<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California-San Francisco, San Francisco</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Vaduganathan, Muthiah" sort="Vaduganathan, Muthiah" uniqKey="Vaduganathan M" first="Muthiah" last="Vaduganathan">Muthiah Vaduganathan</name>
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<nlm:affiliation>Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Cardiovascular Division, Brigham and Women's Hospital, Boston</wicri:cityArea>
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</author>
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<name sortKey="Vardeny, Orly" sort="Vardeny, Orly" uniqKey="Vardeny O" first="Orly" last="Vardeny">Orly Vardeny</name>
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<nlm:affiliation>Pharmacy Practice Division, Minneapolis VA Center for Care Delivery and Outcomes Research and University of Minnesota, Minneapolis, Minnesota.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Pharmacy Practice Division, Minneapolis VA Center for Care Delivery and Outcomes Research and University of Minnesota, Minneapolis</wicri:cityArea>
</affiliation>
</author>
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<name sortKey="Whellan, David J" sort="Whellan, David J" uniqKey="Whellan D" first="David J" last="Whellan">David J. Whellan</name>
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<nlm:affiliation>Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Department of Medicine, Thomas Jefferson University, Philadelphia</wicri:cityArea>
</affiliation>
</author>
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<name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name>
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<placeName>
<region type="state">District de Columbia</region>
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<name sortKey="Anker, Stefan D" sort="Anker, Stefan D" uniqKey="Anker S" first="Stefan D" last="Anker">Stefan D. Anker</name>
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<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>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</wicri:regionArea>
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<region type="land" nuts="3">Berlin</region>
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<name sortKey="O Connor, Christopher M" sort="O Connor, Christopher M" uniqKey="O Connor C" first="Christopher M" last="O'Connor">Christopher M. O'Connor</name>
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<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Inova Heart and Vascular Institute, Falls Church, Virginia; Duke University Medical Center and Duke Clinical Research Institute, Durham</wicri:cityArea>
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<title level="j">Journal of the American College of Cardiology</title>
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<term>Coronavirus Infections (MeSH)</term>
<term>Endpoint Determination (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Pneumonia, Viral (MeSH)</term>
<term>Socioeconomic Factors (MeSH)</term>
<term>Statistics as Topic (MeSH)</term>
</keywords>
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<term>Détermination du point final (MeSH)</term>
<term>Essais cliniques comme sujet (MeSH)</term>
<term>Facteurs socioéconomiques (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Infections à coronavirus (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Pneumopathie virale (MeSH)</term>
<term>Statistiques comme sujet (MeSH)</term>
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<term>COVID-19</term>
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<term>Coronavirus Infections</term>
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<front>
<div type="abstract" xml:lang="en">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.</div>
</front>
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<DateCompleted>
<Year>2020</Year>
<Month>11</Month>
<Day>19</Day>
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<DateRevised>
<Year>2020</Year>
<Month>12</Month>
<Day>10</Day>
</DateRevised>
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<ISSN IssnType="Electronic">1558-3597</ISSN>
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<Volume>76</Volume>
<Issue>20</Issue>
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<Year>2020</Year>
<Month>11</Month>
<Day>17</Day>
</PubDate>
</JournalIssue>
<Title>Journal of the American College of Cardiology</Title>
<ISOAbbreviation>J Am Coll Cardiol</ISOAbbreviation>
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<ArticleTitle>Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.</ArticleTitle>
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<MedlinePgn>2368-2378</MedlinePgn>
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<Abstract>
<AbstractText>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.</AbstractText>
<CopyrightInformation>Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
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<LastName>Psotka</LastName>
<ForeName>Mitchell A</ForeName>
<Initials>MA</Initials>
<AffiliationInfo>
<Affiliation>Inova Heart and Vascular Institute, Falls Church, Virginia. Electronic address: https://twitter.com/mpsotka.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Abraham</LastName>
<ForeName>William T</ForeName>
<Initials>WT</Initials>
<AffiliationInfo>
<Affiliation>Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. Electronic address: William.Abraham@osumc.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Fiuzat</LastName>
<ForeName>Mona</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina. Electronic address: https://twitter.com/mfiuzat.</Affiliation>
</AffiliationInfo>
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<LastName>Filippatos</LastName>
<ForeName>Gerasimos</ForeName>
<Initials>G</Initials>
<AffiliationInfo>
<Affiliation>University of Cyprus Medical School, Shakolas Educational Center for Clinical Medicine, Nicosia, Cyprus.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Lindenfeld</LastName>
<ForeName>JoAnn</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Heart Failure and Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Tariq</ForeName>
<Initials>T</Initials>
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<Affiliation>Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bhatt</LastName>
<ForeName>Ankeet S</ForeName>
<Initials>AS</Initials>
<AffiliationInfo>
<Affiliation>Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Carson</LastName>
<ForeName>Peter E</ForeName>
<Initials>PE</Initials>
<AffiliationInfo>
<Affiliation>Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Cleland</LastName>
<ForeName>John G F</ForeName>
<Initials>JGF</Initials>
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<Affiliation>Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.</Affiliation>
</AffiliationInfo>
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<ForeName>G Michael</ForeName>
<Initials>GM</Initials>
<AffiliationInfo>
<Affiliation>Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Januzzi</LastName>
<ForeName>James L</ForeName>
<Initials>JL</Initials>
<Suffix>Jr</Suffix>
<AffiliationInfo>
<Affiliation>Cardiology Division, Massachusetts General Hospital and Baim Institute for Clinical Research, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
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<ForeName>Dalane W</ForeName>
<Initials>DW</Initials>
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<Affiliation>Sections on Cardiovascular Medicine and Geriatrics, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Leifer</LastName>
<ForeName>Eric S</ForeName>
<Initials>ES</Initials>
<AffiliationInfo>
<Affiliation>Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Lewis</LastName>
<ForeName>Eldrin F</ForeName>
<Initials>EF</Initials>
<AffiliationInfo>
<Affiliation>Division of Cardiovascular Medicine, Stanford University, Palo Alto, California.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>McMurray</LastName>
<ForeName>John J V</ForeName>
<Initials>JJV</Initials>
<AffiliationInfo>
<Affiliation>BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Mentz</LastName>
<ForeName>Robert J</ForeName>
<Initials>RJ</Initials>
<AffiliationInfo>
<Affiliation>Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Solomon</LastName>
<ForeName>Scott D</ForeName>
<Initials>SD</Initials>
<AffiliationInfo>
<Affiliation>Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
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<ForeName>Norman</ForeName>
<Initials>N</Initials>
<AffiliationInfo>
<Affiliation>United States Food and Drug Administration, Silver Spring, Maryland.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Teerlink</LastName>
<ForeName>John R</ForeName>
<Initials>JR</Initials>
<AffiliationInfo>
<Affiliation>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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Vaduganathan</LastName>
<ForeName>Muthiah</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Vardeny</LastName>
<ForeName>Orly</ForeName>
<Initials>O</Initials>
<AffiliationInfo>
<Affiliation>Pharmacy Practice Division, Minneapolis VA Center for Care Delivery and Outcomes Research and University of Minnesota, Minneapolis, Minnesota.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Whellan</LastName>
<ForeName>David J</ForeName>
<Initials>DJ</Initials>
<AffiliationInfo>
<Affiliation>Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Wittes</LastName>
<ForeName>Janet</ForeName>
<Initials>J</Initials>
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</AffiliationInfo>
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<LastName>Anker</LastName>
<ForeName>Stefan D</ForeName>
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<Affiliation>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.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Christopher M</ForeName>
<Initials>CM</Initials>
<AffiliationInfo>
<Affiliation>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.</Affiliation>
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<CoiStatement>Author Relationship With Industry Dr. Psotka has received consulting fees from Amgen, Cytokinetics, and Windtree; and has received grant support from the U.S. Food and Drug Administration. Dr. Abraham has received consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; has received salary support from V-Wave; and has received research support from the U.S. National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Filippatos has received consulting income from Boehringer Ingelheim, Medtronic, Novartis, Servier, and Vifor; and has received lecture fees from Merck. Dr. Lindenfeld has received consulting fees from Novartis, Abbott, ResMed, V-Wave, CVRx, and Cytokinetics. Dr. Ahmad has received consulting fees from Amgen, Cytokinetics, Relypsa, and Novartis. Dr. Bhatt has received consulting fees from Sanofi Pasteur; and participates in clinical endpoint committees for the U.S. National Institutes of Health. Dr. Cleland has received consulting fees from Abbott, Amgen, Bayer, Medtronic, Novartis, Pharmacosmos, Vifor, Bristol Myers Squibb, and Servier; and has received research grants from Amgen, Bayer, Novartis, Pharmacosmos, Vifor, Bristol Myers Squibb, and Servier. Dr. Felker has received research grants from the National Heart, Lung, and Blood Institute, American Heart Association, Amgen, Merck, Cytokinetics, and Roche Diagnostics; and has received consulting fees from Novartis, Amgen, Bristol Myers Squibb, Cytokinetics, Medtronic, Cardionomic, Relypsa, V-Wave, Myokardia, Innolife, EBR Systems, Arena, Abbott, Sphingotec, Roche Diagnostics, Alnylam, LivaNova, Windtree Therapeutics, Rocket Pharma, and scPharmaceuticals. Dr. Januzzi is a trustee of the American College of Cardiology; has received grant support from Applied Therapeutics, Novartis Pharmaceuticals, and Abbott Diagnostics; has received consulting income from Abbott, Janssen, Novartis, Pfizer, Merck, and Roche Diagnostics; and participates in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Amgen, Boehringer Ingelheim, Janssen, and Takeda. Dr. Kitzman has received consulting fees from AstraZeneca, Bayer, Novartis, Merck, Pfizer, Boehringer Ingelheim, AbbVie, DCRI, and Corvia; has received grant support from AstraZeneca, Bayer, and Novartis; and has stock in Gilead. Dr. Lewis has received consulting fees from Novartis; and has received institutional research grant support from Amgen, Novartis, and Sanofi. Dr. McMurray has received financial support from Bayer, Cardiorentis, Amgen, Oxford University, Theracos, Abbvie, DalCor, Pfizer, Merck, Novartis, GlaxoSmithKline, Bristol Myers Squibb, Vifor-Fresenius, Kidney Research UK, and AstraZeneca. Dr. Mentz has received consulting fees from Abbott, Amgen, AstraZeneca, Bayer, Boston Scientific, Janssen, Luitpold, Medtronic, Merck, Novartis, and Sanofi; and has received research grants from Akros, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, GlaxoSmithKline, Gilead, InnoLife, Luitpold/American Reagent, Novartis, Otsuka, ResMed, and the U.S. National Institutes of Health grants U01HL125511-01A1 and R01AG045551-01A1. Dr. Solomon has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Bristol Myers Squibb, Celladon, Cytokinetics, Eidos, Gilead, GlaxoSmithKline, Ionis, Lone Star Heart, Mesoblast, MyoKardia, U.S. National Institutes of Health/National Heart, Lung, and Blood Institute, Novartis, Sanofi Pasteur, and Theracos; and has received consulting fees from Akros, Alnylam, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Cardior, Corvia, Cytokinetics, Gilead, GlaxoSmithKline, Ironwood, Merck Sharp & Dohme, Novartis, Roche, Takeda, Theracos, Quantum Genetics, Cardurion, AoBiome, Janssen, and Cardiac Dimensions. Dr. Teerlink has received consulting fees from Amgen, Bayer, Cytokinetics, Novartis, and Stealth Health; and has received research funding from Abbott, Amgen, Bayer, Bristol Myers Squibb, Novartis, and scPharmaceuticals. Dr. Vaduganathan is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541); and has served on Advisory Boards for Amgen, AstraZeneca, Baxter Healthcare, Bayer AG, Boehringer Ingelheim, Cytokinetics, and Relypsa. Dr. Vardeny has received consulting fees from Novartis; and has received research grants from AstraZeneca and Sanofi Pasteur. Dr. Whellan has received grant support from the U.S. National Institutes of Health (R01AG045551). Dr. Wittes reports that the company for which she works, Statistics Collaborative, has contracts with many companies, some of which are developing treatments for heart failure. Dr. Anker has received clinical trial–related fees from Abbott Vascular, Servier, Vifor, Bayer, Boehringer Ingelheim, Thermo Fisher, Respicardia, and Novartis. Dr. O’Connor has received research support from Roche Diagnostics and Merck; has been a consultant for Bristol Myers Squibb, Merck, Windtree, and Neurotronik; and is a co-owner of Biscardia. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.</CoiStatement>
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