Historically, the clinical trials landscape for children was one of reticence and ethical concerns.
However, the 1990s brought about a significant change in perspective, as the medical community recognized a pressing need for specialized knowledge about medicines intended for pediatric use. This led to legislative landmarks such as the 2007 EU Paediatric Regulation and the US Best Pharmaceuticals for Children Act. Particularly in the EU, the Paediatric Investigational Plan (PIP) was introduced, paving the way for a rise in the registration of pediatric clinical trials.
Yet, many of these trials did not result in pediatric-centric labeling and formulations, revealing a gap between regulations drafted for adults and the unique requirements of pediatric trials.
In this transformative period, a council of pediatricians and researchers in Belgium formed the Belgian Paediatric Clinical Research Network (BPCRN) to improve clinical trials for children in response to the European 2007 Paediatric Regulation. In 2014, the SAFEPEDRUG project (IWT/SBO 120033) emerged as a concerted effort to bridge gaps and advance pediatric pharmacotherapy in Belgium. SAFEPEDRUG was carefully designed to address the challenges of drug dosing for the pediatric populations of 4 translational therapeutics. By collaborating with various stakeholders and leveraging advanced technologies, SAFEPEDRUG played a pivotal role in steering the pediatric clinical trial narrative toward more targeted and effective approaches. The project evolved into a SAFEPEDRUG clinical trial unit (SPD-CTU), focused on purely clinical trials with children.
Following the initial work by BPCRN in 2009 and by SAFEPEDRUG since 2014, the Belgian Paediatric Clinical Research Network (BPCRN) was successfully relaunched in 2018 which was largely attributable to its integration within a pan-European network for clinical trials, namely the conect4children (c4c) consortium.
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