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Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).

Identifieur interne : 001273 ( Main/Exploration ); précédent : 001272; suivant : 001274

Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).

Auteurs : Stefan D. Anker [Allemagne] ; Javed Butler [États-Unis] ; Muhammad Shahzeb Khan [États-Unis] ; William T. Abraham [États-Unis] ; Johann Bauersachs [Allemagne] ; Edimar Bocchi [Brésil] ; Biykem Bozkurt [États-Unis] ; Eugene Braunwald [États-Unis] ; Vijay K. Chopra [Inde] ; John G. Cleland [Royaume-Uni] ; Justin Ezekowitz [Canada] ; Gerasimos Filippatos [Grèce] ; Tim Friede [Allemagne] ; Adrian F. Hernandez [États-Unis] ; Carolyn S P. Lam [Singapour, Pays-Bas] ; Joann Lindenfeld [États-Unis] ; John J V. Mcmurray [Royaume-Uni] ; Mandeep Mehra [États-Unis] ; Marco Metra [Italie] ; Milton Packer [États-Unis] ; Burkert Pieske [Allemagne] ; Stuart J. Pocock [Royaume-Uni] ; Piotr Ponikowski [Pologne] ; Giuseppe M C. Rosano [Italie, Royaume-Uni] ; John R. Teerlink [États-Unis] ; Hiroyuki Tsutsui [Japon] ; Dirk J. Van Veldhuisen [Pays-Bas] ; Subodh Verma [Canada] ; Adriaan A. Voors [Pays-Bas] ; Janet Wittes [États-Unis] ; Faiez Zannad [France] ; Jian Zhang [République populaire de Chine] ; Petar Seferovic [Serbie] ; Andrew J S. Coats [Italie]

Source :

RBID : pubmed:32498081

Descripteurs français

English descriptors

Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

DOI: 10.1093/eurheartj/ehaa461
PubMed: 32498081
PubMed Central: PMC7314099


Affiliations:


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Le document en format XML

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<nlm:affiliation>Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</nlm:affiliation>
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<nlm:affiliation>Centre d'Investigation Clinique-Plurithématique INSERM CIC-P 1433, and INSERM U1116, CHRU Nancy Brabois, F-CRIN INI-CRCT, Université de Lorraine, Nancy, France.</nlm:affiliation>
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<name sortKey="Zhang, Jian" sort="Zhang, Jian" uniqKey="Zhang J" first="Jian" last="Zhang">Jian Zhang</name>
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<nlm:affiliation>Heart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China.</nlm:affiliation>
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<nlm:affiliation>San Raffaele Pisana Scientific Institute, Rome, Italy.</nlm:affiliation>
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<title xml:lang="en">Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).</title>
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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>Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Butler, Javed" sort="Butler, Javed" uniqKey="Butler J" first="Javed" last="Butler">Javed Butler</name>
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<nlm:affiliation>Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Medicine, University of Mississippi Medical Center, Jackson, MS</wicri:regionArea>
<placeName>
<region type="state">État du Mississippi</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Khan, Muhammad Shahzeb" sort="Khan, Muhammad Shahzeb" uniqKey="Khan M" first="Muhammad Shahzeb" last="Khan">Muhammad Shahzeb Khan</name>
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<nlm:affiliation>Department of Medicine, Cook County Hospital, Chicago, IL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Medicine, Cook County Hospital, Chicago, IL</wicri:regionArea>
<placeName>
<region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Abraham, William T" sort="Abraham, William T" uniqKey="Abraham W" first="William T" last="Abraham">William T. Abraham</name>
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<nlm:affiliation>Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus, OH, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus, OH</wicri:regionArea>
<placeName>
<region type="state">Ohio</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Bauersachs, Johann" sort="Bauersachs, Johann" uniqKey="Bauersachs J" first="Johann" last="Bauersachs">Johann Bauersachs</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Cardiology and Angiology, Hannover Medical School, Hannover</wicri:regionArea>
<placeName>
<region type="land" nuts="2">Basse-Saxe</region>
<settlement type="city">Hanovre</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Bocchi, Edimar" sort="Bocchi, Edimar" uniqKey="Bocchi E" first="Edimar" last="Bocchi">Edimar Bocchi</name>
<affiliation wicri:level="3">
<nlm:affiliation>Division of Cardiology, Sâo Paulo University Medical School, São Paulo, Brazil.</nlm:affiliation>
<country xml:lang="fr">Brésil</country>
<wicri:regionArea>Division of Cardiology, Sâo Paulo University Medical School, São Paulo</wicri:regionArea>
<placeName>
<settlement type="city">São Paulo</settlement>
<region type="state">État de São Paulo</region>
</placeName>
</affiliation>
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<name sortKey="Bozkurt, Biykem" sort="Bozkurt, Biykem" uniqKey="Bozkurt B" first="Biykem" last="Bozkurt">Biykem Bozkurt</name>
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<nlm:affiliation>Winters Center for Heart Failure Research, Cardiovascular Research Institute, Baylor College of Medicine, Michael E. DeBakey VA Medical Center, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Winters Center for Heart Failure Research, Cardiovascular Research Institute, Baylor College of Medicine, Michael E. DeBakey VA Medical Center, Houston, TX</wicri:regionArea>
<placeName>
<region type="state">Texas</region>
</placeName>
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<author>
<name sortKey="Braunwald, Eugene" sort="Braunwald, Eugene" uniqKey="Braunwald E" first="Eugene" last="Braunwald">Eugene Braunwald</name>
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<nlm:affiliation>Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Brigham and Women's Hospital, Harvard Medical School, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
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<author>
<name sortKey="Chopra, Vijay K" sort="Chopra, Vijay K" uniqKey="Chopra V" first="Vijay K" last="Chopra">Vijay K. Chopra</name>
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<nlm:affiliation>Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India.</nlm:affiliation>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi</wicri:regionArea>
<wicri:noRegion>New Delhi</wicri:noRegion>
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<author>
<name sortKey="Cleland, John G" sort="Cleland, John G" uniqKey="Cleland J" first="John G" last="Cleland">John G. Cleland</name>
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<nlm:affiliation>Robertson Centre for Biostatistics & Clinical Trials, University of Glasgow, Lanarkshire, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Robertson Centre for Biostatistics & Clinical Trials, University of Glasgow, Lanarkshire</wicri:regionArea>
<orgName type="university">Université de Glasgow</orgName>
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<settlement type="city">Glasgow</settlement>
<region type="country">Écosse</region>
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</affiliation>
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<author>
<name sortKey="Ezekowitz, Justin" sort="Ezekowitz, Justin" uniqKey="Ezekowitz J" first="Justin" last="Ezekowitz">Justin Ezekowitz</name>
<affiliation wicri:level="1">
<nlm:affiliation>Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta</wicri:regionArea>
<wicri:noRegion>Alberta</wicri:noRegion>
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<author>
<name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name>
<affiliation wicri:level="3">
<nlm:affiliation>National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.</nlm:affiliation>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea>National and Kapodistrian University of Athens, Attikon University Hospital, Athens</wicri:regionArea>
<placeName>
<settlement type="city">Athènes</settlement>
<region nuts="2" type="region">Attique (région)</region>
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</affiliation>
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<author>
<name sortKey="Friede, Tim" sort="Friede, Tim" uniqKey="Friede T" first="Tim" last="Friede">Tim Friede</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Medical Statistics, University Medical Center Goettingen; and German Centre for Cardiovascular Research (DZHK), partner site Goettingen, Goettingen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Medical Statistics, University Medical Center Goettingen; and German Centre for Cardiovascular Research (DZHK), partner site Goettingen, Goettingen</wicri:regionArea>
<wicri:noRegion>Goettingen</wicri:noRegion>
<wicri:noRegion>Goettingen</wicri:noRegion>
<wicri:noRegion>Goettingen</wicri:noRegion>
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</author>
<author>
<name sortKey="Hernandez, Adrian F" sort="Hernandez, Adrian F" uniqKey="Hernandez A" first="Adrian F" last="Hernandez">Adrian F. Hernandez</name>
<affiliation wicri:level="2">
<nlm:affiliation>Division of Cardiology, Duke University Medical Center, Durham, NC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Cardiology, Duke University Medical Center, Durham, NC</wicri:regionArea>
<placeName>
<region type="state">Caroline du Nord</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lam, Carolyn S P" sort="Lam, Carolyn S P" uniqKey="Lam C" first="Carolyn S P" last="Lam">Carolyn S P. Lam</name>
<affiliation wicri:level="1">
<nlm:affiliation>National Heart Centre Singapore, Duke-National University of Singapore, Singapore.</nlm:affiliation>
<country xml:lang="fr">Singapour</country>
<wicri:regionArea>National Heart Centre Singapore, Duke-National University of Singapore</wicri:regionArea>
<wicri:noRegion>Duke-National University of Singapore</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen</wicri:regionArea>
<placeName>
<settlement type="city">Groningue</settlement>
<region nuts="2" type="province">Groningue (province)</region>
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</affiliation>
</author>
<author>
<name sortKey="Lindenfeld, Joann" sort="Lindenfeld, Joann" uniqKey="Lindenfeld J" first="Joann" last="Lindenfeld">Joann Lindenfeld</name>
<affiliation wicri:level="2">
<nlm:affiliation>Vanderbilt Heart and Vascular Institute, Nashville, TN, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vanderbilt Heart and Vascular Institute, Nashville, TN</wicri:regionArea>
<placeName>
<region type="state">Tennessee</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Mcmurray, John J V" sort="Mcmurray, John J V" uniqKey="Mcmurray J" first="John J V" last="Mcmurray">John J V. Mcmurray</name>
<affiliation wicri:level="4">
<nlm:affiliation>BHF Cardiovascular Research Center, University of Glasgow, Glasgow, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>BHF Cardiovascular Research Center, 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="Mehra, Mandeep" sort="Mehra, Mandeep" uniqKey="Mehra M" first="Mandeep" last="Mehra">Mandeep Mehra</name>
<affiliation wicri:level="2">
<nlm:affiliation>Heart and Vascular Center, Brigham and Women's Hospital, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Heart and Vascular Center, Brigham and Women's Hospital, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Metra, Marco" sort="Metra, Marco" uniqKey="Metra M" first="Marco" last="Metra">Marco Metra</name>
<affiliation wicri:level="1">
<nlm:affiliation>Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia</wicri:regionArea>
<wicri:noRegion>Brescia</wicri:noRegion>
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</author>
<author>
<name sortKey="Packer, Milton" sort="Packer, Milton" uniqKey="Packer M" first="Milton" last="Packer">Milton Packer</name>
<affiliation wicri:level="2">
<nlm:affiliation>Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX</wicri:regionArea>
<placeName>
<region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Pieske, Burkert" sort="Pieske, Burkert" uniqKey="Pieske B" first="Burkert" last="Pieske">Burkert Pieske</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum; Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum; Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Berlin</wicri:regionArea>
<placeName>
<region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
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</affiliation>
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<author>
<name sortKey="Pocock, Stuart J" sort="Pocock, Stuart J" uniqKey="Pocock S" first="Stuart J" last="Pocock">Stuart J. Pocock</name>
<affiliation wicri:level="3">
<nlm:affiliation>London School of Hygiene and Tropical Medicine, London, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
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</affiliation>
</author>
<author>
<name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Heart Disease, University Hospital, Medical University, Wrocław, Poland.</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Department of Heart Disease, University Hospital, Medical University, Wrocław</wicri:regionArea>
<wicri:noRegion>Wrocław</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Rosano, Giuseppe M C" sort="Rosano, Giuseppe M C" uniqKey="Rosano G" first="Giuseppe M C" last="Rosano">Giuseppe M C. Rosano</name>
<affiliation wicri:level="3">
<nlm:affiliation>IRCCS San Raffaele Pisana, Rome, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>IRCCS San Raffaele Pisana, Rome</wicri:regionArea>
<placeName>
<settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
</placeName>
</affiliation>
<affiliation wicri:level="3">
<nlm:affiliation>St George's Medical School, London, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>St George's Medical School, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Teerlink, John R" sort="Teerlink, John R" uniqKey="Teerlink J" first="John R" last="Teerlink">John R. Teerlink</name>
<affiliation wicri:level="2">
<nlm:affiliation>Section of Cardiology, San Francisco Veterans Affairs Medical Center, School of Medicine, University of California, San Francisco, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Section of Cardiology, San Francisco Veterans Affairs Medical Center, School of Medicine, University of California, San Francisco, San Francisco, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Tsutsui, Hiroyuki" sort="Tsutsui, Hiroyuki" uniqKey="Tsutsui H" first="Hiroyuki" last="Tsutsui">Hiroyuki Tsutsui</name>
<affiliation wicri:level="4">
<nlm:affiliation>Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.</nlm:affiliation>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka</wicri:regionArea>
<orgName type="university">Université de Kyūshū</orgName>
<placeName>
<settlement type="city">Fukuoka</settlement>
<region type="province">Kyūshū</region>
<region type="prefecture">Préfecture de Fukuoka</region>
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</affiliation>
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<author>
<name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J" last="Van Veldhuisen">Dirk J. Van Veldhuisen</name>
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<nlm:affiliation>Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen</wicri:regionArea>
<placeName>
<settlement type="city">Groningue</settlement>
<region nuts="2" type="province">Groningue (province)</region>
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<author>
<name sortKey="Verma, Subodh" sort="Verma, Subodh" uniqKey="Verma S" first="Subodh" last="Verma">Subodh Verma</name>
<affiliation wicri:level="4">
<nlm:affiliation>Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto</wicri:regionArea>
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<settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
<orgName type="university">Université de Toronto</orgName>
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<author>
<name sortKey="Voors, Adriaan A" sort="Voors, Adriaan A" uniqKey="Voors A" first="Adriaan A" last="Voors">Adriaan A. Voors</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen</wicri:regionArea>
<placeName>
<settlement type="city">Groningue</settlement>
<region nuts="2" type="province">Groningue (province)</region>
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<author>
<name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name>
<affiliation wicri:level="2">
<nlm:affiliation>Statistics Collaborative, Inc., Washington, DC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Statistics Collaborative, Inc., Washington, DC</wicri:regionArea>
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<region type="state">District de Columbia</region>
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<author>
<name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name>
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<nlm:affiliation>Centre d'Investigation Clinique-Plurithématique INSERM CIC-P 1433, and INSERM U1116, CHRU Nancy Brabois, F-CRIN INI-CRCT, Université de Lorraine, Nancy, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Centre d'Investigation Clinique-Plurithématique INSERM CIC-P 1433, and INSERM U1116, CHRU Nancy Brabois, F-CRIN INI-CRCT, Université de Lorraine, Nancy</wicri:regionArea>
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<region type="region">Grand Est</region>
<region type="old region">Lorraine (région)</region>
<settlement type="city">Nancy</settlement>
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<author>
<name sortKey="Zhang, Jian" sort="Zhang, Jian" uniqKey="Zhang J" first="Jian" last="Zhang">Jian Zhang</name>
<affiliation wicri:level="3">
<nlm:affiliation>Heart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Heart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing</wicri:regionArea>
<placeName>
<settlement type="city">Pékin</settlement>
</placeName>
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<author>
<name sortKey="Seferovic, Petar" sort="Seferovic, Petar" uniqKey="Seferovic P" first="Petar" last="Seferovic">Petar Seferovic</name>
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<nlm:affiliation>University of Belgrade Faculty of Medicine; Serbian Academy of Sciences and Arts, Belgrade, Serbia.</nlm:affiliation>
<country xml:lang="fr">Serbie</country>
<wicri:regionArea>University of Belgrade Faculty of Medicine; Serbian Academy of Sciences and Arts, Belgrade</wicri:regionArea>
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<author>
<name sortKey="Coats, Andrew J S" sort="Coats, Andrew J S" uniqKey="Coats A" first="Andrew J S" last="Coats">Andrew J S. Coats</name>
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<nlm:affiliation>San Raffaele Pisana Scientific Institute, Rome, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>San Raffaele Pisana Scientific Institute, Rome</wicri:regionArea>
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<settlement type="city">Rome</settlement>
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<div type="abstract" xml:lang="en">The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.</div>
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<CopyrightInformation>Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.</CopyrightInformation>
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<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Brésil</li>
<li>Canada</li>
<li>France</li>
<li>Grèce</li>
<li>Inde</li>
<li>Italie</li>
<li>Japon</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>République populaire de Chine</li>
<li>Serbie</li>
<li>Singapour</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Attique (région)</li>
<li>Basse-Saxe</li>
<li>Berlin</li>
<li>Californie</li>
<li>Caroline du Nord</li>
<li>District de Columbia</li>
<li>Grand Est</li>
<li>Grand Londres</li>
<li>Groningue (province)</li>
<li>Illinois</li>
<li>Kyūshū</li>
<li>Latium</li>
<li>Lorraine (région)</li>
<li>Massachusetts</li>
<li>Ohio</li>
<li>Ontario</li>
<li>Préfecture de Fukuoka</li>
<li>Tennessee</li>
<li>Texas</li>
<li>Écosse</li>
<li>État de São Paulo</li>
<li>État du Mississippi</li>
</region>
<settlement>
<li>Athènes</li>
<li>Berlin</li>
<li>Fukuoka</li>
<li>Glasgow</li>
<li>Groningue</li>
<li>Hanovre</li>
<li>Londres</li>
<li>Nancy</li>
<li>Pékin</li>
<li>Rome</li>
<li>São Paulo</li>
<li>Toronto</li>
</settlement>
<orgName>
<li>Université de Glasgow</li>
<li>Université de Kyūshū</li>
<li>Université de Lorraine</li>
<li>Université de Toronto</li>
</orgName>
</list>
<tree>
<country name="Allemagne">
<noRegion>
<name sortKey="Anker, Stefan D" sort="Anker, Stefan D" uniqKey="Anker S" first="Stefan D" last="Anker">Stefan D. Anker</name>
</noRegion>
<name sortKey="Bauersachs, Johann" sort="Bauersachs, Johann" uniqKey="Bauersachs J" first="Johann" last="Bauersachs">Johann Bauersachs</name>
<name sortKey="Friede, Tim" sort="Friede, Tim" uniqKey="Friede T" first="Tim" last="Friede">Tim Friede</name>
<name sortKey="Pieske, Burkert" sort="Pieske, Burkert" uniqKey="Pieske B" first="Burkert" last="Pieske">Burkert Pieske</name>
</country>
<country name="États-Unis">
<region name="État du Mississippi">
<name sortKey="Butler, Javed" sort="Butler, Javed" uniqKey="Butler J" first="Javed" last="Butler">Javed Butler</name>
</region>
<name sortKey="Abraham, William T" sort="Abraham, William T" uniqKey="Abraham W" first="William T" last="Abraham">William T. Abraham</name>
<name sortKey="Bozkurt, Biykem" sort="Bozkurt, Biykem" uniqKey="Bozkurt B" first="Biykem" last="Bozkurt">Biykem Bozkurt</name>
<name sortKey="Braunwald, Eugene" sort="Braunwald, Eugene" uniqKey="Braunwald E" first="Eugene" last="Braunwald">Eugene Braunwald</name>
<name sortKey="Hernandez, Adrian F" sort="Hernandez, Adrian F" uniqKey="Hernandez A" first="Adrian F" last="Hernandez">Adrian F. Hernandez</name>
<name sortKey="Khan, Muhammad Shahzeb" sort="Khan, Muhammad Shahzeb" uniqKey="Khan M" first="Muhammad Shahzeb" last="Khan">Muhammad Shahzeb Khan</name>
<name sortKey="Lindenfeld, Joann" sort="Lindenfeld, Joann" uniqKey="Lindenfeld J" first="Joann" last="Lindenfeld">Joann Lindenfeld</name>
<name sortKey="Mehra, Mandeep" sort="Mehra, Mandeep" uniqKey="Mehra M" first="Mandeep" last="Mehra">Mandeep Mehra</name>
<name sortKey="Packer, Milton" sort="Packer, Milton" uniqKey="Packer M" first="Milton" last="Packer">Milton Packer</name>
<name sortKey="Teerlink, John R" sort="Teerlink, John R" uniqKey="Teerlink J" first="John R" last="Teerlink">John R. Teerlink</name>
<name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name>
</country>
<country name="Brésil">
<region name="État de São Paulo">
<name sortKey="Bocchi, Edimar" sort="Bocchi, Edimar" uniqKey="Bocchi E" first="Edimar" last="Bocchi">Edimar Bocchi</name>
</region>
</country>
<country name="Inde">
<noRegion>
<name sortKey="Chopra, Vijay K" sort="Chopra, Vijay K" uniqKey="Chopra V" first="Vijay K" last="Chopra">Vijay K. Chopra</name>
</noRegion>
</country>
<country name="Royaume-Uni">
<region name="Écosse">
<name sortKey="Cleland, John G" sort="Cleland, John G" uniqKey="Cleland J" first="John G" last="Cleland">John G. Cleland</name>
</region>
<name sortKey="Mcmurray, John J V" sort="Mcmurray, John J V" uniqKey="Mcmurray J" first="John J V" last="Mcmurray">John J V. Mcmurray</name>
<name sortKey="Pocock, Stuart J" sort="Pocock, Stuart J" uniqKey="Pocock S" first="Stuart J" last="Pocock">Stuart J. Pocock</name>
<name sortKey="Rosano, Giuseppe M C" sort="Rosano, Giuseppe M C" uniqKey="Rosano G" first="Giuseppe M C" last="Rosano">Giuseppe M C. Rosano</name>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Ezekowitz, Justin" sort="Ezekowitz, Justin" uniqKey="Ezekowitz J" first="Justin" last="Ezekowitz">Justin Ezekowitz</name>
</noRegion>
<name sortKey="Verma, Subodh" sort="Verma, Subodh" uniqKey="Verma S" first="Subodh" last="Verma">Subodh Verma</name>
</country>
<country name="Grèce">
<region name="Attique (région)">
<name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name>
</region>
</country>
<country name="Singapour">
<noRegion>
<name sortKey="Lam, Carolyn S P" sort="Lam, Carolyn S P" uniqKey="Lam C" first="Carolyn S P" last="Lam">Carolyn S P. Lam</name>
</noRegion>
</country>
<country name="Pays-Bas">
<region name="Groningue (province)">
<name sortKey="Lam, Carolyn S P" sort="Lam, Carolyn S P" uniqKey="Lam C" first="Carolyn S P" last="Lam">Carolyn S P. Lam</name>
</region>
<name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J" last="Van Veldhuisen">Dirk J. Van Veldhuisen</name>
<name sortKey="Voors, Adriaan A" sort="Voors, Adriaan A" uniqKey="Voors A" first="Adriaan A" last="Voors">Adriaan A. Voors</name>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Metra, Marco" sort="Metra, Marco" uniqKey="Metra M" first="Marco" last="Metra">Marco Metra</name>
</noRegion>
<name sortKey="Coats, Andrew J S" sort="Coats, Andrew J S" uniqKey="Coats A" first="Andrew J S" last="Coats">Andrew J S. Coats</name>
<name sortKey="Rosano, Giuseppe M C" sort="Rosano, Giuseppe M C" uniqKey="Rosano G" first="Giuseppe M C" last="Rosano">Giuseppe M C. Rosano</name>
</country>
<country name="Pologne">
<noRegion>
<name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name>
</noRegion>
</country>
<country name="Japon">
<region name="Kyūshū">
<name sortKey="Tsutsui, Hiroyuki" sort="Tsutsui, Hiroyuki" uniqKey="Tsutsui H" first="Hiroyuki" last="Tsutsui">Hiroyuki Tsutsui</name>
</region>
</country>
<country name="France">
<region name="Grand Est">
<name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name>
</region>
</country>
<country name="République populaire de Chine">
<noRegion>
<name sortKey="Zhang, Jian" sort="Zhang, Jian" uniqKey="Zhang J" first="Jian" last="Zhang">Jian Zhang</name>
</noRegion>
</country>
<country name="Serbie">
<noRegion>
<name sortKey="Seferovic, Petar" sort="Seferovic, Petar" uniqKey="Seferovic P" first="Petar" last="Seferovic">Petar Seferovic</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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