Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation

IntroductionThe high failure rate of industry-driven pediatric clinical trials leads to insufficient timely labeling of drugs in children and a lack of scientific evidence, resulting in the persistently high off-label drug use. National clinical trial networks can facilitate collaboration between sites, investigators, and experts, increasing the likelihood of successful trials. Within the conect4children (c4c) network, an Innovative Medicines Initiative 2-funded project, National Hubs hosted by National Clinical Trials Networks were set up across 21 European countries to facilitate the setup and execution of pediatric clinical trials. In this paper, we aim to present the performance metrics of the trial feasibility process as well as learnings and challenges encountered by the Belgian and Dutch Networks in working within the European c4c project.MethodThe c4c National Hubs streamline pediatric clinical trials by initiating early country outreach, identifying overlapping studies, recommending quality trial sites, and supporting trial budgeting for both industry and academic settings. To show the impact of Pedmed-NL and Belgian Pediatric Clinical Research Network (BPCRN), internal metrics were collected from 2019 to 2022 on four industry-sponsored and three academic trials performed within the c4c network. Timelines and outcomes of the site identification were collected and analyzed for industry trials. A qualitative analysis was conducted through c4c platforms, sponsor interactions, and stakeholder engagement to evaluate the added value of a research network.ResultsIn industry-sponsored trials, full feasibility questionnaires were completed within 2 weeks (n = 48), and inclusion rates were up to 80% of clinical sites. Before committing to c4c, 14% of sites were contacted by industry, leading to communication burdens. Utilizing national infrastructure knowledge and therapeutic environment insights helped optimize trial timelines and address feasibility challenges. In addition, national adaptations, such as bilingual staff and site development, played a role in streamlining trial operations in both academic and industry settings. Performance and experiences were similar for both networks.ConclusionThe early-facilitation examples from the c4c trials demonstrated promising metrics for two National Hubs, including optimized start-up timelines and aiding site selection quality. The learnings and challenges of the Belgian and Dutch Networks provided insights for the development of clinical research networks

A broad survey to determine paediatric clinical trial requirements within Belgium

Update on the progression of clinical trials within BPCRN/c4c. Patient Engagement activities were illustrated. Results of a questionnaire, conducted in 2021, portrayed which involving the majority of sites connected within BPCRN. Within the Belgian network, around 4 (30%) of sites do not have a paediatric clinical trial unit to support the trial. All sites agreed or strongly agreed that a national hub is useful for the site to conduct clinical trials. The majority namely 11 (84%) of sites identified human resources as a core improvement need for sites, specifically finding dedicated clinical research nurses and finding time for principal investigators (PI) to perform study tasks aside from clinical work. A strong need for financing of infrastructure from 10 (76%) of sites is acknowledged for consultation areas, imaging, and a biobank structure. On the contrary, 12 (92%) of sites did not regard study-specific courses as a priority. In order to foster sustainable development of new medicines in paediatric diseases, site need’s must to be taken into account and prioritized. The primary need is in human resources and financing of infrastructure. Further investigation into how a centralized organization can support is needed

How to involve medical students within clinical trial networks?

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