The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children.
The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children.
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DOI：
10.1007/s40290-020-00373-6
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发表时间：
2021-03
影响因子：
2.5
通讯作者：
Giaquinto C
中科院分区：
文献类型：
--
作者：
Turner MA;Hildebrand H;Fernandes RM;de Wildt SN;Mahler F;Hankard R;Leary R;Bonifazi F;Nobels P;Cheng K;Attar S;Rossi P;Rocchi F;Claverol J;Nafria B;Giaquinto C
随着2007年《儿科条例》的实施，欧洲联盟（欧盟）认识到需要关于儿童使用的新药物和现有药物的信息。2017年，对《儿科法规》的10年审查确定了开展临床试验的障碍，包括推迟设立和完成儿科试验。在整个欧洲，国家内部和国家之间的差异加剧了临床研究的困难。伦理和监管审查具有国家特殊性。本文介绍了欧洲儿童临床试验合作网络（conect 4children，c4 c），它解决了儿科临床试验设计和实施中的一些困难。c4 c是一个由创新药物倡议（IMI 2）资助的有时限的公私联盟。c4 c的要素如下：提供研究设计和/或儿科开发项目（包括患者参与活动）方面的专家建议;遵循由国家中心协调的统一程序的研究中心网络和欧洲的单一联系人;为研究中心和试验团队提供教育和培训的设施;以及支持管理网络使用的数据和通用儿科数据词典。c4 c不赞助试验。c4 c正在采取分阶段的办法，通过行业和非行业研究进行认真的试点，以证明网络的可行性（可行性证明研究）。c4 c采用一种共同设计的办法，在明确界定的范围内让工业界和学术界参与。一个向所有潜在服务用户开放的可持续的后续组织将在2024年IMI 2资金结束前开放。
The need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials. Across Europe, the difficulties with clinical research are compounded by variation within countries and between countries. Ethics and regulatory review have national specificities. This paper describes the Collaborative Network for European Clinical Trials for Children (conect4children, c4c), which addresses selected difficulties in the design and conduct of paediatric clinical trials. c4c is a time-limited public–private consortium funded by the Innovative Medicines Initiative (IMI2). The elements of c4c are as follows: expert advice providing input on study design and/or paediatric development programmes (including patient involvement activities); a network of sites following harmonised procedures coordinated by National Hubs and a single point of contact for Europe; a facility for education and training for sites and trial teams; and support for managing data used by the network and a common paediatric data dictionary. c4c does not sponsor trials. c4c is taking a phased approach with careful piloting through industry and non-industry studies intended to demonstrate the viability of the network (proof-of-viability studies). c4c uses a co-design approach involving industry and academics within a clearly defined scope. A sustainable, successor organization open to all potential service users will be open for business before the end of IMI2 funding in 2024.
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影响因子：
3.6
作者：
Ward, Robert M.;Benjamin, Daniel;Turner, Mark A.
通讯作者：
Turner, Mark A.
影响因子：
3.2
作者：
Michaels, Debra L.;Lamberti, Mary Jo;Getz, Kenneth
通讯作者：
Getz, Kenneth
影响因子：
5.2
作者：
Lepola P;Needham A;Mendum J;Sallabank P;Neubauer D;de Wildt S
通讯作者：
de Wildt S
影响因子：
2.9
作者：
van den Anker, John;Reed, Michael D.;Kearns, Gregory L.
通讯作者：
Kearns, Gregory L.