Two small girls

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…

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…

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…

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…

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.…

How c4c is improving European paediatric clinical research through partnerships

“The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children” has been published in Pharmaceutical Medicine.   Clinical trial scientists and their teams, for several decades, have partially succeeded in improving ways on how paediatric trials are conducted. In 2007, the European Union recognised the need to facilitate development of medicines…

c4c publication on efficient paediatric formulation development

“Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a c4c expert group White paper” has been published by British Journal of Clinical Pharmacology.   Despite regulatory requirements and incentives, paediatric formulations still lag behind adult formulations for medicines used in both adults and children. This is largely due to…