Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children – CTS Journal – Wiley Online Library
Many medicines are used “off-label” in children outside the terms of the license and 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 promoting innovative trial design, c4c set up a European multidisciplinary advice service, including the voice of young patients and families (PPI), tailored to industry and academia. A network of experts was established to provide multidisciplinary advice to trial sponsors. Twenty-four clinical and innovative methodology expert groups (>400 experts) and a PPI database of 135 registrants were established. Up to the end of September 2022, 25 advice requests have already been completed. Sponsors appreciated the advice quality and the multidisciplinary experts from different countries, including experts not known before. The c4c project has shown successful proof of concept for a service that presents a new framework to plan innovative and feasible pediatric trials.
You can read the full article here.
AI in Paediatrics Webinar
A very successful webinar on Artificial Intelligence (AI) in paediatrics took place on the 7th of December 2022.
We can look back on a very successful webinar on Artificial Intelligence (AI) in paediatrics which took place on the 7th of December 2022.
Renowned speakers provided engaging presentations which were followed by interesting discussions with the participants. The topics of the presentations were: literature searches and AI, Paediatric Asthma and AI, AI and drug metabolising enzymes, AI and Ethical considerations and dose machine learning, which provided eye-opening insights on the (potential) use of AI in paediatrics.
No less than 80 people from over 20 different countries participated in the webinar.
We would like to thank all participants for joining the webinar and a special thanks to the organizers and speakers who made this webinar possible and a great success: Matthias Schwab, Anne Smits, Dirk Lanzerath, Jolien Freriksen, Anke-Hilse Maitland van der Zee, Maaike van der Lee and Wei Zhao!
Publications of White Papers:
c4c Experts have contributed to the visibility of c4c as well as the c4c goal of knowledge transfer between groups with the objective to have high quality input into paediatric development plans and study designs, including the promotion of innovative trial design and scientific methods by publishing several (white) papers.
- “Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper” provides a better understanding of our group.
- “Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper“
- “c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper“
- “Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the Conect4children project“
- “How paediatric drug development and use could benefit from OMICs: a c4c expert group white paper“
- “Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group“
The c4c Formulation Expert Group has made an informative video, giving an overview of their published paper: ‘Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper’. The video can be found here.