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Practice Guideline
. 2020 Jun 7;41(22):2109-2117.
doi: 10.1093/eurheartj/ehaa461.

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)

Stefan D Anker  1 , Javed Butler  2 , Muhammad Shahzeb Khan  3 , William T Abraham  4 , Johann Bauersachs  5 , Edimar Bocchi  6 , Biykem Bozkurt  7 , Eugene Braunwald  8 , Vijay K Chopra  9 , John G Cleland  10 , Justin Ezekowitz  11 , Gerasimos Filippatos  12 , Tim Friede  13 , Adrian F Hernandez  14 , Carolyn S P Lam  15   16 , JoAnn Lindenfeld  17 , John J V McMurray  18 , Mandeep Mehra  19 , Marco Metra  20 , Milton Packer  21 , Burkert Pieske  22 , Stuart J Pocock  23 , Piotr Ponikowski  24 , Giuseppe M C Rosano  25   26 , John R Teerlink  27 , Hiroyuki Tsutsui  28 , Dirk J Van Veldhuisen  16 , Subodh Verma  29 , Adriaan A Voors  16 , Janet Wittes  30 , Faiez Zannad  31 , Jian Zhang  32 , Petar Seferovic  33 , Andrew J S Coats  34
Affiliations
Practice Guideline

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)

Stefan D Anker et al. Eur Heart J. .

Erratum in

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.

Keywords: COVID-19; Clinical trials; Coronavirus; Heart failure.

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Figures

Figure 1
Figure 1
A summary of issues along with the possible solutions related to patient and staff safety in the conduct of clinical trials due to the COVID-19 pandemic. Problems related to data quality and perseveration of scientific integrity are also highlighted along with their possible solutions. HCP, healthcare providers.
See this image and copyright information in PMC

Comment in

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