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Impact of COVID-19 disease on clinical research in pediatric and congenital cardiology - 30/06/22

Doi : 10.1016/j.arcped.2022.03.004 
V. Pommier a, H. Abassi a, b, K. Lavastre a, J. Calderon a, b, c, S. Guillaumont a, d, Y. Dulac e, F. Auriol e, C. Ovaert f, A. Blondelon f, S. Hascoet g, F. Lecerf g, C. Jore h, M. Avesani h, J.-B. Thambo h, i, P. Amedro h, i,
a Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Clinical Investigation Centre, University Hospital, Montpellier, France 
b PhyMedExp, CNRS, INSERM, University of Montpellier, Montpellier, France 
c Cardiac Neurodevelopmental Program, Department of Psychiatry, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, United States 
d Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France 
e Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Toulouse University Hospital, Toulouse CIC 1436, France 
f Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, APHM La Timone University Hospital, Marseille, France 
g Pediatric and Congenital Cardiology Department, M3C National Reference Centre, Centre Medico-Chirurgical Marie-Lannelongue, Le Plessis-Robinson, France 
h Pediatric and Congenital Cardiology Department, M3C National Reference Centre, Bordeaux University Hospital, Avenue de Magellan, Bordeaux 33604, France 
i IHU Liryc, Electrophysiology and Heart Modelling Institute, INSERM 1045, Bordeaux University Foundation, Pessac, France 

Corresponding author.

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Abstract

Background

COVID-19 triggered an unprecedented crisis affecting society at every level. Research in pediatric and congenital cardiology is currently in full development and may have been disrupted. The aim of the study was to determine the impact of COVID-19 on pediatric and congenital cardiology clinical research and to analyze decision-making and adaptation processes, from a panel of ongoing academic and industry-sponsored research at the time of the pandemic.

Methods

This observational study was carried out in April 2020, from a CHD clinical research network involving five tertiary care pediatric and congenital cardiology centers. Investigators and clinical research assistants from each participating research center completed an online survey questionnaire, and each principal investigator underwent a 1-h web-based videoconference interview.

Results

A total of 34 study questionnaires were collected, reporting that 18 studies were totally suspended. Upon the investigator's decision, after discussion on ethical issues and with facilitating support from health authorities, 16 studies were resumed. The rate of study suspension in interventional research (53%) was similar to that in non-interventional research (56%). Logistical problems were predominantly reported in both continued and suspended trials. Research protocols were adapted, largely thanks to telemedicine, which in some cases even improved the course of the study.

Conclusion

The impact of the COVID-19 pandemic on clinical research in pediatric and congenital cardiology has been limited by a rapid adaptation of all research structures and an extensive use of telemedicine at all stages of the studies.

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Keywords : SARS-CoV-2, Drug trials, Randomized controlled trial, Pandemic, Congenital heart disease

Abbreviations : CHD, COVID-19, IRB, M3C, RCT, SARS-CoV-2


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© 2022  French Society of Pediatrics. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 29 - N° 5

P. 347-353 - juillet 2022 Retour au numéro
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