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Priority Needs for Conducting Pandemic-Relevant Clinical Research With Children in Europe: A Consensus Study With Pediatric Clinician-Researchers.

Gal, M; Gobat, N; Francis, NA; Hood, K; Butler, CC; Bielicki, J; Fraaij, PL; Sharland, M; Jarvis, J; van Rossum, AMC; et al. Gal, M; Gobat, N; Francis, NA; Hood, K; Butler, CC; Bielicki, J; Fraaij, PL; Sharland, M; Jarvis, J; van Rossum, AMC; Heikkinen, T; Martinon-Torres, F; Herberg, J; Watkins, A; Webb, SAR; Moore, R; Sukumar, P; Nichol, A (2019) Priority Needs for Conducting Pandemic-Relevant Clinical Research With Children in Europe: A Consensus Study With Pediatric Clinician-Researchers. Pediatr Infect Dis J, 38 (5). e82-e86. ISSN 1532-0987 https://doi.org/10.1097/INF.0000000000002204
SGUL Authors: Bielicki, Julia Anna

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Abstract

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.

Item Type: Article
Additional Information: This is a non-final version of an article published in final form in Gal, M; Gobat, N; Francis, NA; Hood, K; Butler, CC; Bielicki, J; Fraaij, PL; Sharland, M; Jarvis, J; van Rossum, AMC; et al. (2019) Priority Needs for Conducting Pandemic-Relevant Clinical Research With Children in Europe: A Consensus Study With Pediatric Clinician-Researchers. Pediatr Infect Dis J, 38 (5). e82-e86.
Keywords: 1114 Paediatrics And Reproductive Medicine, Pediatrics
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Pediatr Infect Dis J
ISSN: 1532-0987
Language: eng
Dates:
DateEvent
May 2019Published
25 September 2018Published Online
30 August 2018Accepted
Publisher License: Publisher's own licence
Projects:
Project IDFunderFunder ID
602525Seventh Framework Programmehttp://dx.doi.org/10.13039/501100004963
PubMed ID: 30256315
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/110244
Publisher's version: https://doi.org/10.1097/INF.0000000000002204

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