Due to the implementation of European Paediatric Regulation in 2007, the number of children to be involved in clinical trials is constantly growing in Europe. Nevertheless, paediatric research infrastructure is not developing at the same pace as for adults and there is increased competition between paediatric studies for shared resources (investigators, sites, patients). This provokes a considerable delay in availability of innovative medicines for children and negative impact on academic research.
The success of many paediatric clinical trials depends on a public private partnership between multiple stakeholders including private sponsors and publicly funded organisation. For that reason, IMI proposes to create a European initiative that promotes the rapid delivery of paediatric drug trials through improved uniform processes in a coordinated, sustainable network that is widely accessible. The overall vision of this proposal is to create a large collaborative paediatric network that will facilitate the development and availability of new drugs and other therapies, and the expansion of knowledge about drugs currently used in the paediatric population. This will be accomplished by not only advising on how best to do the necessary research, but by actually building sufficient infrastructure and best practices to support planning, running, and completion of all types of clinical studies profit and not for profit.
The main objectives of the full project are:
- building a network with a lean central coordinating organisation, arranged around ‘national hub coordinating centres’ cooperating with multiple sites within each EU member state;
installing scientific advice and trial readiness groups to consult with sponsors on the scientific soundness and feasibility of their proposals and to drive innovation;
developing and implementing standardised processes, procedures, and performance metrics for initiation and execution of studies and maintenance of high-level performance across the network;
- Testing viability of the network by measuring performance metrics during the execution and completion of a number of different clinical studies from different sponsors (industry, non-industry) and different therapeutic areas, across all age groups.
The project will greatly impact on the future access for paediatric patients to new experimental therapies in well-designed clinical trials and it will improve the efficiency in executing trials (reduced timelines and reduced cost). At the same time the role of clinicians and patient/parent advocacy groups in planning and designing studies will be improved, broadening the access of academic medical centres and clinical faculty across Europe to new experimental therapies for multiple clinical indications.
INCiPiT will actively participate into the call as the Italian hub for paediatric clinical trials.