The European Health Data Space needs to be relevant for paediatric data to support future medicines development for children – a conect4children viewpoint

In April 2024, Members of the European Parliament (MEPs) approved the creation of the European Health Data Space (EHDS). The EHDS aims to improve citizens’ access to and control over their electronic health data for primary (healthcare) and secondary (clinical research) uses. Anticipating the endorsement of the EHDS Regula􀆟on, c4c held a workshop in February…

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New Report: Workshop on Engaging with the European Health Data Space: The Paediatric Perspective

Workshop Aims and Objectives: Explore how to increase alignment of conect4children (an IMI2 initiative that was established to overcome the many barriers to the planning and delivery of effective and efficient paediatric clinical trials) with the European Health Data Space and policy making in a European context. Main aims: – To gain a better understanding…

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New Publication: Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration

The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and reusability of paediatric clinical trial data is challenging due to a lack of standardization. The Clinical Data Interchange Standards Consortium (CDISC) standards that are required or recommended for regulatory…

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Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery

Despite global efforts to improve paediatric clinical trials, significant delays continue in paediatric drug approvals. Collaboration between research networks is needed to address these delays. This paper is a first step to promote interoperability between paediatric networks from different jurisdictions by comparing drivers for, and content of, metrics about clinical trial conduct. To read full…

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Joint recommendations on cost calculation and estimation in paediatric clinical trials

The conduct of clinical trials in paediatrics is essential to improve drug therapy in children. In Europe, paediatric clinical trials have been supported by the European Paediatric Regulation since 2007, but there is still a great need for high-quality clinical trials. The personnel and time required to conduct clinical trials in accordance with EU Regulations…

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New Publication: Disease-specific data standardization

c4c are delighted to announce a new publication about Disease-specific data standardization. Standardization of disease-specific paediatric clinical trial data is a hugely challenging task. c4c brought together representatives from large initiatives, major data standards, well-known data dictionaries, patient registries, and clinical trial repositories with provisions for clinical data, to build a collaborative action plan for…

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Psychopharmacology in children and adolescents: unmet needs and opportunities

Psychopharmacological treatment is an important component of the multimodal intervention approach to treating mental health conditions in children and adolescents. Currently, there are many unmet needs but also opportunities, alongside possible risks to consider, regarding the pharmacological treatment of mental health conditions in children and adolescents. In this Position Paper, we highlight and address these…

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

Introduction: The 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,…

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