As of 2017 Pedmed-NL is the Dutch network to facilitate paediatric clinical trials. Since then, the network developed into a collaborative consortium consisting of 17 Dutch hospitals (including all University Medical Centers) and the Patient Alliance for Rare and Genetic Disease (VSOP). One of the roles of Pedmed-NL is being the Dutch National Hub (NH) within the conect4children (c4c) project.
The director of Pedmed-NL is Prof dr Saskia de Wildt, paediatric intensivist and clinical pharmacologist and she leads our team located at Radboudumc in Nijmegen, The Netherlands. We are motivated to improve the paediatric clinical trial infrastructure and the quality of trials, both initiated by industry and academic initiated trials. To do so, we have set up a well-connected network, a database with over 200 contacts with a broad range of clinical trial expertise and several services.
Within our network we organize regular meetings, either to discuss operational topics (every 6 weeks) or strategic topics (3 times a year), but mainly to involve our Pedmed-NL consortium members and identify the needs within our network. Here we pick up topics that need to be addressed and helps us to prioritize. For instance, the network indicated the need for adequate budget estimates to determine the costs to perform clinical trials. So we set up a working group, including multiple consortium members, to develop a budget tool to be used for investigators to estimate the costs for their trial and implement this is their grant application, but also to make sure a trial can be performed for the budget available for industry trials. Additionally, we organize a yearly face-to-face meeting to inform our members and colleagues about the networks development and to share experiences.
We aim to facilitate every paediatric clinical trial related enquiry from both academia and the pharmaceutical industry to provide advice and information along the whole clinical trial cycle. For now, we are focussing on feasibility assessments and site identification, but we are working towards a full support package portfolio, including to support grant applications, budget estimates, contracting, applications to ethics committees and competent authorities. Up to now, we have only supported the academic and industry Proof of viability studies within c4c, but also handled over 130 feasibility requests not related to c4c and were involved in 4 grant applications, for which we collaborate with multiple national clinical expertise networks. By providing these services, we foster high quality paediatric drug research.
