The development of the Belgian paediatric clinical trial network.

IF 1.6 4区 医学 Q2 Medicine Acta Clinica Belgica Pub Date : 2024-02-01 Epub Date: 2024-01-02 DOI:10.1080/17843286.2023.2283664
E Degraeuwe, L Persijn, L Nuytinck, K Allegaert, L De Taeye, E Gasthuys, D Christiaens, S Karamaria, A Raes, M Turner, J Vande Walle
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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.

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比利时儿科临床试验网络的发展。
儿科临床试验对于确保儿童处方药安全有效至关重要。然而,此类药物的循证剂量和标签仍然有限,大多数儿科临床试验都以失败告终。导致试验无法完成的因素包括研究机构的表现(招募的患者有限、研究机构员工经验有限、缺乏基础设施)、赞助商团队(设计方面的儿科专业知识有限、生物标志物或结果变量的可靠性不确定)以及监管和行政负担。由于对现场支持的需求日益增长,在创新药物倡议2(IMI2)泛欧网络connect4children(c4c)和跨大西洋网络I-ACT for Children(美国)的支持下,成立于2009年的比利时儿科临床研究网络(BPCRN)于2018年重新启动,以改善儿科临床试验。国家网络可以提高试验质量、安全性和效率,提供临床研究专业知识,确定合适的试验场地,并帮助解决常见试验问题。BPCRN 的集中化方法通过简化沟通和规范试验行为,推动了儿科临床试验的发展。挑战与机遇并存,包括 2018 年的重新启动、孤儿药试验和网络的可持续性。网络活动之间的合作、政府的支持、研究机构层面的改进、高效的沟通以及与产业界的互动是实现儿科医学研究持久转型的关键。
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来源期刊
Acta Clinica Belgica
Acta Clinica Belgica 医学-医学:内科
CiteScore
2.90
自引率
0.00%
发文量
44
审稿时长
6-12 weeks
期刊介绍: Acta Clinica Belgica: International Journal of Clinical and Laboratory Medicine primarily publishes papers on clinical medicine, clinical chemistry, pathology and molecular biology, provided they describe results which contribute to our understanding of clinical problems or describe new methods applicable to clinical investigation. Readership includes physicians, pathologists, pharmacists and physicians working in non-academic and academic hospitals, practicing internal medicine and its subspecialties.
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