Establishing a Nordic Network for Clinical Trials in Children – stage 2

Children need better access to safe and effective medicines addressing their therapeutic needs. Due to this demand, the European Union a special Paediatric Regulation (Regulation (EC) no 1901/2006) came into force in 2007. The effect of the Regulation will be seen in the near future, as the forthcoming trials require urgently new trial sites, investigators and patients. Currently, over 1 000 new Paediatric Investigation Plans (PIP) has been agreed by the European Medicines Agency (EMA), leading to the recruitment need for more than 500 000 children in Europe over the next 5 years.

A Finnish network FINPEDMED (Finnish Investigators Network for Pediatric Medicines) was established in 2007. In Norway, the Medicines for Children Research Network (NorPedMed) was established in 2013. With funding from the Nordforsk Nordic Trial Alliance – NordicPedMed –project (Stage I) in 2014-2015, it was possible to initiate the development of National paediatric clinical networks also in Denmark, Iceland and Sweden. That project concluded that a Nordic network of these National networks is feasible, and developed feasibility plan with Organizational Principles and rationale for NordicPedMed. A Nordic network of national networks, will be more competitive and more attractive than National networks separately, by having a larger population for the recruitment base (5.4 million children), and more comparable to Networks of the large European countries. This gives Nordic countries more leverage both within the Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) and in discussions with the industry.

In the very near future, there are several new paediatric clinical trial infrastructure initiatives about to start in Europe. All these initiatives aim at building European infrastructure with interoperable processes for paediatric clinical trials. These initiatives create opportunities for significant funding available and under consideration, which alongside provide the funding necessary to develop NordicPedMed clinical trial sites to high professional standards. However, full participation in these project consortiums requires that a network has Enpr-EMA Category I network status or comparable. Currently only FINPEDMED fills this requirement.

The second development phase (Stage II) of NordicPedMed is «Establishing a Nordic Network for Clinical Trials in Children». This includes a rapid building of governance and management infrastructure for NordicPedMed. The official governance and management will allow NordicPedMed to apply Enpr-EMA membership and participate in the infrastructure consortiums, opening new possibilities for other Nordic national networks to join the European paediatric clinical trials infrastructure in the most flexible way once they reach the organisational maturity needed. For full operations, NordicPedMed will also develop common IT-structure, including a common investigator´s registry, employing existing FinPedMed IT- structure and operational model for Nordic investigators network for paediatric Clinical Trials.

Facts about the project
Project manager

Clinical Research Institute HUCH
Project Leader: Pirkko Lepola