1. 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)
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Petar M. Seferovic, Subodh Verma, Hiroyuki Tsutsui, Jian Zhang, JoAnn Lindenfeld, John G.F. Cleland, Carolyn S.P. Lam, Johann Bauersachs, Eugene Braunwald, Giuseppe M.C. Rosano, Janet Wittes, Javed Butler, Stuart J. Pocock, Mandeep R. Mehra, Gerasimos Filippatos, Marco Metra, John J.V. McMurray, Muhammad Shahzeb Khan, Piotr Ponikowski, Vijay K. Chopra, Stefan D. Anker, Dirk J. van Veldhuisen, Andrew J.S. Coats, Adrian F. Hernandez, Burkert Pieske, Justin A. Ezekowitz, William T. Abraham, Edimar Alcides Bocchi, Tim Friede, John R. Teerlink, Biykem Bozkurt, Milton Packer, Faiez Zannad, Adriaan A. Voors, and Cardiovascular Centre (CVC)
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medicine.medical_specialty ,Social contract ,Clinical trials ,Coronavirus ,COVID-19 ,Heart failure ,Clinical Trials as Topic ,Europe ,Humans ,Informed Consent ,Patient Safety ,Patient Selection ,Research Design ,Betacoronavirus ,Coronavirus Infections ,Heart Failure ,Pandemics ,Pneumonia, Viral ,Clinical Sciences ,Cardiorespiratory Medicine and Haematology ,030204 cardiovascular system & hematology ,03 medical and health sciences ,Patient safety ,0302 clinical medicine ,Internal medicine ,Pandemic ,Medicine ,Viral ,030212 general & internal medicine ,Association (psychology) ,business.industry ,Risk of infection ,Pneumonia ,medicine.disease ,3. Good health ,Clinical trial ,Cardiovascular System & Hematology ,Cardiology ,Position paper ,Cardiology and Cardiovascular Medicine ,business - Abstract
Author(s): Anker, Stefan D; Butler, Javed; Khan, Muhammad Shahzeb; Abraham, William T; Bauersachs, Johann; Bocchi, Edimar; Bozkurt, Biykem; Braunwald, Eugene; Chopra, Vijay K; Cleland, John G; Ezekowitz, Justin; Filippatos, Gerasimos; Friede, Tim; Hernandez, Adrian F; Lam, Carolyn SP; Lindenfeld, JoAnn; McMurray, John JV; Mehra, Mandeep; Metra, Marco; Packer, Milton; Pieske, Burkert; Pocock, Stuart J; Ponikowski, Piotr; Rosano, Giuseppe MC; Teerlink, John R; Tsutsui, Hiroyuki; Van Veldhuisen, Dirk J; Verma, Subodh; Voors, Adriaan A; Wittes, Janet; Zannad, Faiez; Zhang, Jian; Seferovic, Petar; Coats, Andrew JS | 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.
- Published
- 2020
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