1. Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research: A Pan-European and Canadian Snapshot in Time
- Author
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Olivier L. Mantha, Florence Flamein, Mark A. Turner, Ricardo M. Fernandes, Régis Hankard, Ruth Ladenstein, Andrea Mikolasek, Daphné Christiaens, Eva Degraeuwe, Johan Vande Walle, Lieve Nuytinck, Elise Mok, Jonathon L. Maguire, Thierry Lacaze-Masmonteil, Pavla Pokorna, Pernille Skovby, Heli Rajasaar, Jaana Kallio, Pirkko Lepola, Christele Gras-Le Guen, Frédéric Gottrand, Florentia Kaguelidou, Hugues Chevassus, Isabelle Pin, Jérémie Rouger-Gaudichon, Maya Patel, Eva Neumann, Matthias Schwab, Elias Losifidis, Emmanuel Roilides, Máiréad Murray, Federica La Neve, Francesca Rocchi, Sigrun Margrethe Hjelle, Thomas Halvorsen, Marek Migdał, Aleksander Wiśniewski, Inês Zimbarra Cabrita, Rita Carilho Torrão, Tiago Martins, Cristina Serén Trasorras, Federico Martinón-Torres, Anders Rane, Estelle Naumburg, Klara M. Posfay-Barbe, Manuel Diezi, Paolo Paioni, Fenna Mahler, Saskia N. de Wildt, Tesa Van der Geest, and Karen Wilding
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Canada ,Clinical Trials as Topic ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Pediatric research ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,MEDLINE ,COVID-19 ,Context (language use) ,Original Articles ,Europe ,Clinical research ,Pan european ,Pediatrics, Perinatology and Child Health ,Pandemic ,Emergency medicine ,Humans ,Medicine ,Renal disorders Radboud Institute for Health Sciences [Radboudumc 11] ,Child ,business - Abstract
Contains fulltext : 242783.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To capture the early effects of the coronavirus disease 2019 (COVID-19) pandemic on pediatric clinical research. STUDY DESIGN: Pediatric clinical research networks from 20 countries and 50 of their affiliated research sites completed two surveys over one month from early May to early June 2020. Networks liaised with their affiliated sites and contributed to the interpretation of results through pan-European group discussions. Based on first detection dates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), countries formed 1 early detecting and 1 late detecting cluster. We tested the hypothesis that this clustering influenced clinical research. RESULTS: Research sites were first impacted by the pandemic in mid-March 2020 (March 16 ± 10 days, the same date as lockdown initiation; P = .99). From first impact up until early June, site initiation and feasibility analysis processes were affected for >50% of the sites. Staff were redirected to COVID-19 research for 44% of the sites, and 75.5% of sites were involved in pediatric COVID-19 research (only 6.3% reported COVID-19 cases in their other pediatric trials). Mitigation strategies were used differently between the early and late detecting country clusters and between countries with and without a pediatric COVID-19 research taskforce. Positive effects include the development of teleworking capacities. CONCLUSIONS: Through this collaborative effort from pediatric research networks, we found that pediatric trials were affected and conducted with a range of unequally applied mitigations across countries during the pandemic. The global impact might be greater than captured. In a context where clinical research is increasingly multinational, this report reveals the importance of collaboration between national networks.
- Published
- 2021
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