Περίληψη:
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. © 2020 Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020.
Συγγραφείς:
Anker, S.D.
Butler, J.
Khan, M.S.
Abraham, W.T.
Bauersachs, J.
Bocchi, E.
Bozkurt, B.
Braunwald, E.
Chopra, V.K.
Cleland, J.G.
Ezekowitz, J.
Filippatos, G.
Friede, T.
Hernandez, A.F.
Lam, C.S.P.
Lindenfeld, J.
McMurray, J.J.V.
Mehra, M.
Metra, M.
Packer, M.
Pieske, B.
Pocock, S.J.
Ponikowski, P.
Rosano, G.M.C.
Teerlink, J.R.
Tsutsui, H.
Van Veldhuisen, D.J.
Verma, S.
Voors, A.A.
Wittes, J.
Zannad, F.
Zhang, J.
Seferovic, P.
Coats, A.J.S.
Λέξεις-κλειδιά:
consensus development; coronavirus disease 2019; follow up; health care planning; health education; heart failure; human; infection control; morbidity; mortality rate; pandemic; patient participation; priority journal; professional standard; Review; screening test; social distance; stakeholder engagement; adverse outcome; Asia; Australia; biostatistician; cardiac patient; cardiology; clinical effectiveness; clinical trial (topic); consensus; coronavirus disease 2019; data analysis; Europe; health care delivery; health care organization; high risk population; infection risk; medical documentation; medical expert; medical research; medical society; North America; pandemic; patient safety; randomization; research subject; Severe acute respiratory syndrome coronavirus 2; South America; teleconference
