The UK National Node, jointly represented by University College London (UCL) and Sheffield Children’s NHS Foundation Trust (NHS), combines advanced quantitative pharmacology expertise with clinical and translational health technology infrastructure to support paediatric research and innovation, providing integrated regulatory and translational support services including clinical trial protocol development, regulatory pathway mapping, device classification, conformity assessment strategies, and market access preparation, alongside intellectual property management, partnering support, and exploitation planning, while operating within robust ethical, quality, and regulatory frameworks aligned with EU and international standards to function as a multidisciplinary hub enabling the safe, efficient, and evidence-based development and clinical implementation of paediatric therapeutics and medical technologies.
The UCL component, through the Clinical Pharmacology & Therapeutics Group, functions as a specialised modelling and simulation hub for model-informed drug development. It provides advanced in silico approaches for paediatric clinical trial design and optimisation, including pharmacokinetic/pharmacodynamic (PK/PD) modelling, exposure–response analysis, virtual patient cohorts and digital twins, dose rationale development, and extrapolation of efficacy and safety across populations and therapeutic areas. These methods support regulatory and clinical decision-making, particularly in Phase II study design, adaptive trials, biomarker-informed strategies, and paediatric investigation plans.
The NHS component, through the NIHR HealthTech Research Centre in Paediatrics and Child Health and the National Centre for Child Health Technology (HRC/NCCHT), provides a comprehensive translational infrastructure for paediatric medical device and health technology development. It supports end-to-end innovation activities including co-design with children, families, and clinicians, prototype development and validation, usability and human factors evaluation, and real-world clinical assessment. NHS also offers specialised capabilities in in vitro and in vivo testing, biocompatibility studies, and prototype performance validation to ensure safety and regulatory readiness.