EU researchers aim to make more medicines tailored for children. In the 1980s, during the AIDS epidemic, children were excluded from clinical trials, which led to a lack of life-saving medicines for them. Professor Carlo Giaquinto, a paediatrician and president of the Penta Foundation, stresses the importance of including children in clinical trials. The Innovative Medicines Initiative (IMI) is supporting several projects to improve clinical trials for children, including the seven-year connect4children (c4c) project that aims to streamline and enhance pediatric clinical trials across Europe.
The c4c project involves over 60 organizations from 20 countries and includes pharmaceutical companies like Bayer, Johnson & Johnson, and Novartis. The goal is to create a European network for pediatric clinical trials, making more medicines available to children. Despite some progress, fewer than 50% of medicines commonly used in children have been studied in this population.
Children's clinical trials are more complex due to varying metabolic rates across age groups and the need for specially tailored formulations. The c4c team is working to ensure doctors can run these trials effectively and provide support to families. They are also developing documentation and templates to standardize the process.
The project is also setting up a Dutch non-profit foundation, connect4children Stichting, to continue supporting pediatric trials after the project's end. Traditional clinical trials are time-consuming and expensive, but platform trials offer more flexibility, allowing for multiple drugs to be tested simultaneously and for patients to switch treatments as needed.
EU-PEARL, another EU-funded project, has developed a framework for platform trials, which is being used for diseases like major depressive disorder, tuberculosis, and neurofibromatosis. This framework helps speed up drug development and includes patient input in trial design, particularly beneficial for rare diseases with limited patient pools.
Platform trials can significantly improve drug development for children, addressing an ethical need to provide the best evidence for treatments in this vulnerable population. | BGNES
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