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…

Paediatric Inflammatory Bowel Disease

Paediatric Inflammatory Bowel Disease: : A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents  Background and Aims: Despite recent approvals for new drugs to treat adults with Crohn’s disease or ulcerative colitis, there are only two ap[1]proved advanced treatment options [infliximab and adalimumab] for children with inflammatory bowel disease [IBD]. There are…

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…