Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work…
Many medicines are used “off-label” in children outside the terms of the license. Feasible pediatric clinical trials are a challenge to design. Conect4children (c4c) is an Innovative Medicines Initiative project to set up a pan-European pediatric clinical trial network aiming to facilitate the development of new medicines for children. To optimize pediatric trial development by…
To understand the challenges arising out of these principles, the c4c team at Newcastle University conducted semi-structured interviews with four c4c industry partners.
Pharmacometric modelling plays a key role in both the design and analysis of regulatory trials in paediatric drug development. Studies in adults provide a rich source of data to inform the paediatric investigation plans, including knowledge on drug pharmacokinetics (PK), safety and efficacy. In children, drug disposition differs widely from birth to adolescence but extrapolating…
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…
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
Conducting clinical trials (CTs) in the paediatric population can be difficult due to ethical, regulatory, methodological, and commercial issues influencing many factors such as procedures, sample size, and company strategies. On one hand, the lack of evidence-based research and the unmet medical needs, and on the other hand, the low investment of pharma companies in…
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.…
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…
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…
