A1 Refereed original research article in a scientific journal
Priority Needs for Conducting Pandemic-Relevant Clinical Research With Children in Europe : A Consensus Study With Pediatric Clinician-Researchers
Authors: Gal Micaela, Gobat Nina, Francis Nicholas A., Hood Kerenza, Butler Christopher C., Bielicki Julia, Fraaij Pieter L., Sharland Mike, Jarvis Jessica, van Rossum Annemarie, Heikkinen Terho, Martinon-Torres Federico, Herberg Jethro, Watkins Angela, Webb Steve A.R., Moore Ronnie, Sukumar Prasanth, Nichol Alistair
Publisher: Williams & Wilkins
Publication year: 2019
Journal: Pediatric Infectious Disease Journal
Volume: 38
Issue: 5
First page : e82
Last page: e86
Number of pages: 5
ISSN: 0891-3668
DOI: https://doi.org/10.1097/INF.0000000000002204
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/39405125
Background: Infectious disease pandemics (IDP) pose a considerable global threat and can disproportionately affect vulnerable populations including children. Pediatric clinical research in pandemics is essential to improve children’s healthcare and minimize risks of harm by interventions that lack an adequate evidence base for this population. The unique features of IDPs require consideration of special processes to facilitate clinical research. We aimed to obtain consensus on pediatric clinician-researchers’ perceptions of the priorities to feasibly conduct clinical pediatric pandemic research in Europe.
Methods: Mixed method study in 2 stages, recruiting pediatric clinician-researchers with experience of conducting pediatric infectious disease (ID) research in clinical settings in Europe. Stage one was an expert stakeholder workshop and interviews. Discussions focused on participant’s experience of conducting pediatric ID research and processes to facilitate pandemic research. Information informed stage two; an on-line consensus survey to identify pediatric clinician-researchers priorities to enable IDP research.
Results: Twenty-three pediatric clinician-researchers attended the workshop and thirty-nine completed the survey. Priorities were primarily focused on structural and operational requirements of research design and regulation: 1) Clarity within the European Clinical Trials Directive for pediatric pandemic research; 2) Simplified regulatory processes for research involving clinical samples and data; and 3) Improved relationships between regulatory bodies and researchers.
Conclusions: Results suggest that changes need to be made to the current regulatory environment to facilitate and improve pediatric research in the pandemic context. These findings can provide expert evidence to research policy decision makers and regulators and to develop a strategy to lobby for change.
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