Institute of Lifecourse and Medical Sciences, University of Liverpool, Liverpool Health Partners, Liverpool, UK.
Child Health Innovation Leadership Department (CHILD), Johnson and Johnson, High Wycombe, UK.
Br J Clin Pharmacol. 2022 Oct;88(10):4258-4266. doi: 10.1111/bcp.14545. Epub 2020 Sep 20.
Paediatric drug development faces several barriers. These include fragmentation of stakeholders and inconsistent processes during the conduct of research. This review summarises recent efforts to overcome these barriers in Europe. Two exemplar initiatives are described. The European Paediatric Translational Research Infrastructure facilitates preclinical research and other work that underpins clinical trials. conect4children facilitates the design and implementation of clinical trials. Both these initiatives listen to the voices of children and their advocates. Coordination of research needs specific effort that supplements work on science, resources and the policy context.
儿科药物研发面临诸多障碍。这些障碍包括利益相关者的分散和研究过程中不一致的流程。本综述总结了欧洲近期为克服这些障碍所做的努力。描述了两个典范倡议。欧洲儿科转化研究基础设施促进了临床试验的基础临床前研究和其他工作。conect4children 有助于临床试验的设计和实施。这两个倡议都倾听了儿童及其倡导者的声音。协调研究需求需要具体的努力,以补充科学、资源和政策环境方面的工作。