Pediatric clinical Research Infrastructure Service Model

In the PRISM project, professional clinical research infrastructures and service-oriented organisations will offer the paediatric clinical research community high-quality, leading-edge and coordinated TransNational Access (TNA) services for the design, planning and conduct of paediatric interventional or observational clinical studies. Services include end-to-end support for the design, planning and execution of multinational studies conducted in 3 to 6 countries in Europe and Canada (TNA1, WP1, 50% of total budget); consulting services for the planning and design of paediatric studies (TNA2, WP2) and virtual services (TNA3, WP4) on leading-edge methodologies, new trial designs (including platform trials, trials within cohorts, decentralised trials), and access to AI and digital tools, following final development and adaptation to paediatric needs (WP5). Supported paediatric studies will be selected based on scientific excellence and public health relevance by an independent expert panel (WP3), with a two-stage procedure for the TNA1 allowing for support to the planning and design of short-listed projects between the first and second steps, thus optimising the final study protocol before execution. Training will be provided (WP7) for infrastructure staff involved in the development and provision of new services, and for the infrastructure users, i.e. paediatric research and investigation / rare diseases networks, and private or public sponsor teams. Beyond the end of PRISM (WP6), its ambition is offering the paediatric research community coordinated services, avoiding duplication and promoting synergies, according to a mechanism agreed with all the relevant stakeholders in paediatric clinical research (infrastructures, technology providers, sponsors, investigation networks, patients) through contractual arrangements leading to a joint access mechanism.