Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research : A Pan-European and Canadian Snapshot in Time
Copyright © 2021 Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:239 |
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| Enthalten in: |
The Journal of pediatrics - 239(2021) vom: 31. Dez., Seite 67-73.e3 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mantha, Olivier L [VerfasserIn] |
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| Links: |
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| Themen: |
COVID-19 pandemic |
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| Anmerkungen: |
Date Completed 24.11.2021 Date Revised 24.11.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jpeds.2021.08.028 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM329808370 |
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| 100 | 1 | |a Mantha, Olivier L |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research |b A Pan-European and Canadian Snapshot in Time |
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| 500 | |a Date Revised 24.11.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: To capture the early effects of the coronavirus disease 2019 (COVID-19) pandemic on pediatric clinical research | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
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| 700 | 1 | |a Turner, Mark A |e verfasserin |4 aut | |
| 700 | 1 | |a Fernandes, Ricardo M |e verfasserin |4 aut | |
| 700 | 1 | |a Hankard, Régis |e verfasserin |4 aut | |
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| 700 | 1 | |a Mikolasek, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Christiaens, Daphné |e investigator |4 oth | |
| 700 | 1 | |a Degraeuwe, Eva |e investigator |4 oth | |
| 700 | 1 | |a Walle, Johan Vande |e investigator |4 oth | |
| 700 | 1 | |a Nuytinck, Lieve |e investigator |4 oth | |
| 700 | 1 | |a Mok, Elise |e investigator |4 oth | |
| 700 | 1 | |a Maguire, Jonathon L |e investigator |4 oth | |
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| 700 | 1 | |a Lepola, Pirkko |e investigator |4 oth | |
| 700 | 1 | |a Gras-Le Guen, Christele |e investigator |4 oth | |
| 700 | 1 | |a Gottrand, Frédéric |e investigator |4 oth | |
| 700 | 1 | |a Kaguelidou, Florentia |e investigator |4 oth | |
| 700 | 1 | |a Chevassus, Hugues |e investigator |4 oth | |
| 700 | 1 | |a Pin, Isabelle |e investigator |4 oth | |
| 700 | 1 | |a Rouger-Gaudichon, Jérémie |e investigator |4 oth | |
| 700 | 1 | |a Patel, Maya |e investigator |4 oth | |
| 700 | 1 | |a Neumann, Eva |e investigator |4 oth | |
| 700 | 1 | |a Schwab, Matthias |e investigator |4 oth | |
| 700 | 1 | |a Losifidis, Elias |e investigator |4 oth | |
| 700 | 1 | |a Roilides, Emmanuel |e investigator |4 oth | |
| 700 | 1 | |a Murray, Máiréad |e investigator |4 oth | |
| 700 | 1 | |a La Neve, Federica |e investigator |4 oth | |
| 700 | 1 | |a Rocchi, Francesca |e investigator |4 oth | |
| 700 | 1 | |a Hjelle, Sigrun Margrethe |e investigator |4 oth | |
| 700 | 1 | |a Halvorsen, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Migdał, Marek |e investigator |4 oth | |
| 700 | 1 | |a Wiśniewski, Aleksander |e investigator |4 oth | |
| 700 | 1 | |a Cabrita, Inês Zimbarra |e investigator |4 oth | |
| 700 | 1 | |a Torrão, Rita Carilho |e investigator |4 oth | |
| 700 | 1 | |a Martins, Tiago |e investigator |4 oth | |
| 700 | 1 | |a Trasorras, Cristina Serén |e investigator |4 oth | |
| 700 | 1 | |a Martinón-Torres, Federico |e investigator |4 oth | |
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| 700 | 1 | |a Wilding, Karen |e investigator |4 oth | |
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