The development of the Belgian paediatric clinical trial network ...
Paediatric clinical trials are critical to ensure that medications prescribed to children are safe and effective. However, evidence-based dosing and labelling of such medications remain limited, and most clinical trials in paediatrics fail. Factors for lack of trial completion include performance at site level (limited patient recruitment, limited site staff experience and lack of infrastructure), the sponsor team (limited paediatric specific expertise in design, uncertainties on robustness of biomarkers or outcome variables) as well as regulatory and administrative burdens. As a result of the... Mehr ...
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Dokumenttyp: | Journal contribution |
Erscheinungsdatum: | 2023 |
Verlag/Hrsg.: |
Taylor & Francis
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Schlagwörter: | Medicine / Biological Sciences not elsewhere classified / Science Policy |
Sprache: | unknown |
Permalink: | https://search.fid-benelux.de/Record/base-28885034 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://dx.doi.org/10.6084/m9.figshare.24756276 |
Paediatric clinical trials are critical to ensure that medications prescribed to children are safe and effective. However, evidence-based dosing and labelling of such medications remain limited, and most clinical trials in paediatrics fail. Factors for lack of trial completion include performance at site level (limited patient recruitment, limited site staff experience and lack of infrastructure), the sponsor team (limited paediatric specific expertise in design, uncertainties on robustness of biomarkers or outcome variables) as well as regulatory and administrative burdens. As a result of the growing demand for site support, the Belgian Paediatric Clinical Research Network (BPCRN) established in 2009 has been relaunched in 2018 to improve paediatric clinical trials, with the support of innovative-medicines-initiative 2 (IMI2) pan-European network conect4children (c4c) and the transatlantic network I-ACT for Children (US). This paper highlights the formation of the BPCRN and the practical insights it offers ...