Do you know that only about 30% of medicines in Europe and worldwide are authorized for use in paediatrics and that less than 50% of medicines commonly used in children have been properly evaluated in this population? This rate drops to 10% in the vulnerable patient population in neonatal intensive care. The current consensus is that children should be protected from inadequate anecdotal data on use of medicines, including appropriate dose. This protection comes from participation in completed, well-designed clinical trials that generate information on efficacy, dosing, and safety; and are sufficient for regulatory approval. In 2007 the European Paediatric Regulation was implemented to address this challenge. Due to the new regulation the number of paediatric clinical studies, and the number of children involved in such studies has increased steadily. At the same time the infrastructure needed to conduct these studies has not developed at the same pace. This situation has led to increased competition between studies for existing available resources (investigators, sites, patients), delays in completion of studies that are part of Paediatric development plans and consequently delaying availability of innovative medicines to children.
To address these challenges a joint effort of all stakeholders, including pharmaceutical companies and publicly funded organisations (networks, medical centres, learned societies, patient organisations) was needed. Europe’s largest Public Private Partnership the Innovative Medicines Initiative (IMI2) provides a non-competitive space to allow academia and industry to work together to solve issues. IMI2 funds conect4children (c4c), a project to build a pan-European paediatric clinical trial network. The IMI2 consortium consists of 10 Pharma companies and 35 public organisations and networks all working together to meet the challenges and to collectively address children´s needs for better medicines. c4c has also implemented a network of more than 250 clinical sites in 21 European countries enabling more young patients, from across Europe to participate in such studies. c4c hosts a network of more than 300 experts, including Patient/parent experts, supporting study sponsors in designing study protocols that are feasible to conduct whilst meeting the needs of patients. Industry will benefit from the increased number of well-trained clinical sites across Europe, allowing for more efficient study conduct and better quality of data. Ultimately c4c will lead to better medicines for babies, children, and young people.