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…
DetailsWe recently collaborated with FAIRPlus, another IMI funded project, as part of our WP5 data harmonization and standardization tasks to look at ways to make metadata collected about clinical trials more FAIR
DetailsCDISC and conect4children (c4c) release of Paediatrics User Guide to facilitate better medicines for babies, children and young people
DetailsNew c4c paper published – Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary
DetailsTo understand the challenges arising out of these principles, the c4c team at Newcastle University conducted semi-structured interviews with four c4c industry partners.
DetailsPaediatric 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…
DetailsRisk-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
DetailsHow 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.…
Detailsc4c: 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…
DetailsHow 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…
Details
