CDISC and c4c release Paediatrics User Guide
CDISC and conect4children (c4c) release of Paediatrics User Guide to facilitate better medicines for babies, children and young people
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New c4c paper published!
New c4c paper published – Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary
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Understanding Paediatric Data Standards
To understand the challenges arising out of these principles, the c4c team at Newcastle University conducted semi-structured interviews with four c4c industry partners.
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Legal Requirements & Challenges of Clinical Trials
Risk-proportionate approach to Paediatric Clinical Trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation has been published by Clinical Trials
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Paediatric drug development & use could benefit from OMICs
How paediatric drug development and use could benefit from OMICs: A c4c expert group white paper – Neumann – – British Journal of Clinical Pharmacology – Wiley Online Library The safety and efficacy of pharmacotherapy in children, particularly preterms, neonates and infants, is limited by a paucity of good-quality data from prospective clinical drug trials.…
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Paediatric pharmacovigilance
c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper by Aurich et al British Journal of Clinical Pharmacology – Wiley Online Library Children frequently respond differently to therapies compared to adults. Differences also exist between Paediatric age groups for pharmacokinetics and pharmacodynamics in both…
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Clinical Data Modelling
How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium The c4c have published a new article on the Direcht clinical data modelling tool in Applied Sciences. “c4c is piloting the Direcht clinical data modelling tool to model their Cross Cutting…
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Health Technology Assessment of Paediatric Medicines
c4c have published ‘Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project” in British Journal of Clinical Pharmacology. “The medicine development process is complex and requires time and effort to ensure safety, efficacy and quality. In paediatrics, this process is even more challenging, as it involves a subgroup of…
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Improving clinical paediatric research using lessons learnt from COVID-19
c4c experts have published ‘Improving clinical paediatric research and learning from COVID-19: recommendations by the conect4children expert advice group’ in Pediatric Research. The COVID-19 pandemic has resulted in some challenges which c4c partners have had to contend with in their clinical trial operations. COVID-19 affected access to patients; laboratories; study materials; and availability of…
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European research networks to facilitate drug research in children
‘European research networks to facilitate drug research in children’ has been published in the British Journal of Clinical Pharmacology. Paediatric drug development faces several barriers. These include fragmentation of stakeholders and inconsistent processes during the conduct of research. This review summarises recent efforts to overcome these barriers in Europe. Two exemplar initiatives are described.…
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