Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group
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Published:2021-06-07
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ISSN:0031-3998
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Container-title:Pediatric Research
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language:en
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Short-container-title:Pediatr Res
Author:
Ramanan Athimalaipet V.ORCID, Modi Neena, de Wildt Saskia N., Aurich Beate, Bakhtadze Sophia, Sirvent Francisco J. Bautista, Cabañas Fernando, Campbell Lisa, Casanova Michaela, Charlton Philippa, Crandall Wallace, Eichler Irmgard, Fregonese Laura, Hawcutt Daniel B., Iveli Pablo, Jaki Thomas, Jocic-Jakubi Bosanka, Johnson Mats, Kaguelidou Florentina, Karadag Bülent, Kelly Lauren E., Lim Ming, Moreno Carmen, Neumann Eva, Ollivier Cécile, Oualha Mehdi, Raffaeli Genny, Ribeiro Maria A., Roilides Emmanuel, de Rojas Teresa, Simón Alba Rubio San, Ruperto Nicolino, Scarpa Maurizio, Schwab Matthias, Siapkara Angeliki, Singh Yogen, Smits Anne, Striano Pasquale, Urru Silvana A. M., Vivarelli Marina, de Wildt Saskia, Zivkoviz Zorica,
Abstract
Abstract
Background
The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners.
Methods
We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity.
Findings
We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent–patient–public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.
Publisher
Springer Science and Business Media LLC
Subject
Pediatrics, Perinatology, and Child Health
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