The development of the Belgian paediatric clinical trial network
- Author
- Eva Degraeuwe (UGent) , Laura Persijn (UGent) , Lieve Nuytinck (UGent) , Karel Allegaert, Leen De Taeye (UGent) , Elke Gasthuys (UGent) , Daphné Christiaens (UGent) , Sevasti Karamaria (UGent) , Ann Raes (UGent) , Mark Turner (UGent) and Johan Vande Walle (UGent)
- Organization
- Abstract
- 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 for advancing paediatric clinical trials through national networks. A national network can improve trial quality, safety and efficiency, provide clinical research expertise, identify suitable sites, and help with troubleshooting of common trial issues. The BPCRN's centralized approach has advanced paediatric clinical trials by streamlining communication and standardizing trial conduct. Challenges and opportunities have arisen, including a relaunch in 2018, orphan medicine trials, and network sustainability. Collaboration between network activities, government support, site-level improvements, efficient communication, and interaction with industry are key to achieve lasting transformation in paediatric medicine research.
- Keywords
- General Medicine, research networks, paediatrics, BPCRN, Drug development
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Citation
Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-01HH3YVN2TBW1XZN67EKZKC1Q3
- MLA
- Degraeuwe, Eva, et al. “The Development of the Belgian Paediatric Clinical Trial Network.” ACTA CLINICA BELGICA, vol. 79, no. 1, Informa UK Limited, 2024, pp. 34–45, doi:10.1080/17843286.2023.2283664.
- APA
- Degraeuwe, E., Persijn, L., Nuytinck, L., Allegaert, K., De Taeye, L., Gasthuys, E., … Vande Walle, J. (2024). The development of the Belgian paediatric clinical trial network. ACTA CLINICA BELGICA, 79(1), 34–45. https://doi.org/10.1080/17843286.2023.2283664
- Chicago author-date
- Degraeuwe, Eva, Laura Persijn, Lieve Nuytinck, Karel Allegaert, Leen De Taeye, Elke Gasthuys, Daphné Christiaens, et al. 2024. “The Development of the Belgian Paediatric Clinical Trial Network.” ACTA CLINICA BELGICA 79 (1): 34–45. https://doi.org/10.1080/17843286.2023.2283664.
- Chicago author-date (all authors)
- Degraeuwe, Eva, Laura Persijn, Lieve Nuytinck, Karel Allegaert, Leen De Taeye, Elke Gasthuys, Daphné Christiaens, Sevasti Karamaria, Ann Raes, Mark Turner, and Johan Vande Walle. 2024. “The Development of the Belgian Paediatric Clinical Trial Network.” ACTA CLINICA BELGICA 79 (1): 34–45. doi:10.1080/17843286.2023.2283664.
- Vancouver
- 1.Degraeuwe E, Persijn L, Nuytinck L, Allegaert K, De Taeye L, Gasthuys E, et al. The development of the Belgian paediatric clinical trial network. ACTA CLINICA BELGICA. 2024;79(1):34–45.
- IEEE
- [1]E. Degraeuwe et al., “The development of the Belgian paediatric clinical trial network,” ACTA CLINICA BELGICA, vol. 79, no. 1, pp. 34–45, 2024.
@article{01HH3YVN2TBW1XZN67EKZKC1Q3, abstract = {{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 for advancing paediatric clinical trials through national networks. A national network can improve trial quality, safety and efficiency, provide clinical research expertise, identify suitable sites, and help with troubleshooting of common trial issues. The BPCRN's centralized approach has advanced paediatric clinical trials by streamlining communication and standardizing trial conduct. Challenges and opportunities have arisen, including a relaunch in 2018, orphan medicine trials, and network sustainability. Collaboration between network activities, government support, site-level improvements, efficient communication, and interaction with industry are key to achieve lasting transformation in paediatric medicine research.}}, author = {{Degraeuwe, Eva and Persijn, Laura and Nuytinck, Lieve and Allegaert, Karel and De Taeye, Leen and Gasthuys, Elke and Christiaens, Daphné and Karamaria, Sevasti and Raes, Ann and Turner, Mark and Vande Walle, Johan}}, issn = {{1784-3286}}, journal = {{ACTA CLINICA BELGICA}}, keywords = {{General Medicine,research networks,paediatrics,BPCRN,Drug development}}, language = {{eng}}, number = {{1}}, pages = {{34--45}}, publisher = {{Informa UK Limited}}, title = {{The development of the Belgian paediatric clinical trial network}}, url = {{http://doi.org/10.1080/17843286.2023.2283664}}, volume = {{79}}, year = {{2024}}, }
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