Priority needs for conducting pandemic-relevant clinical research with children in Europe: a consensus study with pediatric clinician-researchers
File(s)Final Submitted Manuscript_PIDJ.docx (142.08 KB)
Accepted version
Author(s)
Type
Journal Article
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.
Date Issued
2019-05-01
Date Acceptance
2018-08-30
Citation
Pediatric Infectious Disease Journal, 2019, 38 (5), pp.82-86
ISSN
0891-3668
Publisher
Wolters Kluwer Health
Start Page
82
End Page
86
Journal / Book Title
Pediatric Infectious Disease Journal
Volume
38
Issue
5
Copyright Statement
Copyright © 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30256315
Subjects
Science & Technology
Life Sciences & Biomedicine
Immunology
Infectious Diseases
Pediatrics
children
infectious disease
outbreak
pandemic research
European Directive
Europe
RANDOMIZED CONTROLLED-TRIALS
INFLUENZA
MEDICINES
INFECTION
LESSONS
1114 Paediatrics and Reproductive Medicine
Pediatrics
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2018-09-25