دورية أكاديمية
Priority needs for conducting pandemic-relevant clinical research with children in Europe: a consensus study with pediatric clinician-researchers
| العنوان: | Priority needs for conducting pandemic-relevant clinical research with children in Europe: a consensus study with pediatric clinician-researchers |
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| المؤلفون: | 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 |
| المصدر: | 86 ; 82 |
| بيانات النشر: | Wolters Kluwer Health |
| سنة النشر: | 2018 |
| المجموعة: | Imperial College London: Spiral |
| مصطلحات موضوعية: | 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 |
| جغرافية الموضوع: | United States |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0891-3668 |
| العلاقة: | Pediatric Infectious Disease Journal; http://hdl.handle.net/10044/1/64988Test; https://doi.org/10.1097/INF.0000000000002204Test |
| DOI: | 10.1097/INF.0000000000002204 |
| الإتاحة: | https://doi.org/10.1097/INF.0000000000002204Test http://hdl.handle.net/10044/1/64988Test |
| حقوق: | Copyright © 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. |
| رقم الانضمام: | edsbas.D0611D34 |
| قاعدة البيانات: | BASE |
| تدمد: | 08913668 |
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| DOI: | 10.1097/INF.0000000000002204 |