Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children.
Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children.
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小儿临床研究网络：加速儿童治疗剂的作用。
DOI：
10.1007/s43441-022-00453-6
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发表时间：
2022-11
影响因子：
1.5
通讯作者：
Lacaze-Masmonteil, Thierry
中科院分区：
文献类型：
--
作者：
Greenberg, Rachel G.;McCune, Susan;Attar, Sabah;Hovinga, Collin;Stewart, Breanne;Lacaze-Masmonteil, Thierry
近几十年来，在支持新生儿、婴儿、儿童和年轻人使用的药物开发的政策和立法方面取得了许多进展。本文综述了能够进行研究的网络的特点和性能，以满足监管要求，并在儿科药物开发方面取得进展。网络领导者对网络目标和能力的描述。在美国、欧洲、日本和加拿大，已经组织了临床研究网络，以满足生物制药和学术赞助商及时访问高质量网站的需求，并就药物开发的战略和操作可行性提供建议。每个网络都处理其具体情况，同时努力实现共同的原则，包括标准和时间表;目标和程序的一致性，同时不干扰进行有效试验的安排;广泛的地理覆盖范围;所有年龄组和儿科条件;资金来源;在业绩方面竞争的地点;基准业绩监测，以及优化资源分配的机会;以及对网络成员的教育和培训。促进这些网络之间互动的基础是：每个网络都有一个单一的联络点;对战略和业务可行性评估以及选址采取类似的办法;以及对教育和培训采取协作办法。在五年内，临床研究网络将通过适合当地和全球互操作的方法支持生物制药和公共资助的儿科药物开发的需求。
Recent decades have seen many advances in policy and legislation that support the development of drugs used by neonates, infants, children, and young people. This review summarizes the characteristics and performance of networks capable of conducting studies needed to meet regulatory requirements and make advances in pediatric drug development. Description of network goals and capabilities by network leaders. In the United States, Europe, Japan, and Canada, clinical research networks have been organized to meet the needs of biopharmaceutical and academic sponsors for timely access to high-quality sites, as well as to provide advice about drug development with regard to strategic and operational feasibility. Each network addresses the specificities of its context while working toward shared principles including standards and timelines; alignment of goals and processes, while not disturbing arrangements for conducting trials that work well; wide geographic coverage; all age groups and pediatric conditions; sources of funding; sites that compete on performance; performance monitoring for benchmarking, and opportunities to optimize the allocation of resources; and education and training for network members. Facilitation in interactions among these networks is based on a single point-of-contact for each; similar approaches to strategic and operational feasibility assessment, and site selection; and collaborative approaches to education and training. Within five years, clinical research networks will support the needs of biopharmaceutical and publicly funded pediatric drug development through locally appropriate and globally interoperable approaches.
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影响因子：
8
作者：
Doyle, Lex W.;Davis, Peter G.;Carlin, John B.
通讯作者：
Carlin, John B.
影响因子：
4.4
作者：
Laughon, Matthew M;Benjamin, Daniel K Jr;Cohen-Wolkowiez, Michael
通讯作者：
Cohen-Wolkowiez, Michael
影响因子：
2.5
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
通讯作者：
Giaquinto C
影响因子：
3.7
作者：
Tomasi, Paolo A.;Egger, Gunter F.;Saint-Raymond, Agnes
通讯作者：
Saint-Raymond, Agnes
影响因子：
8
作者：
Pica, Natalie;Bourgeois, Florence
通讯作者：
Bourgeois, Florence