NORDIC investigators network for PEDiatric MEDicines

The following project on pediatrics has been awarded funds by the NTA board as a strategic area:

NORDIC investigators network for PEDiatric MEDicines (NORDICPEDMED)
Project period: 1.1.2014 - 31.12.2014
Project Leader: Pirkko Lepola, Executive Secretary of FINPEDMED, Clinical Research Institute HUCH Ltd.

Project update 19.05.2015

Report from NORDIC investigators network for PEDiatric MEDicines

Project summary
NordicPedMed is a project aiming to set up a Nordic network of investigators, centres and the national networks with recognized expertise in performing clinical studies on children. NordicPedMed aims to develop new innovative approaches built on the strengths of our somewhat similar health care, standards and experience of paediatric clinical research.

The main objectives of NordicPedMed are:

  • Foster high-quality, ethical research on the safety and efficacy of medicines for use in children
  • Enable collaboration between networks and stakeholders
  • Coordinate studies relating to paediatric medicines and avoid unnecessary trials in children
  • Build up scientific and administrative competence at a Nordic level
  • Help with the recruitment of patients for clinical trials

However most importantly, NordicPedMed will benefit sich children in Nordic countries by offering opportunities for early access to new promising medicines in a safe and controlled way in clinical trials.

Background
EU paediatric Regulation (EC 1901/2006) came inro force in 2007 with the aim to imporve the health of children in Europe by increaseing the research adn authorization of medicines for children, and improving the information on medicines designed for children. To meet these objectives, more paediatric clinical trials need to be performed than before, requiring more research capacity; increasing demand for investigators, centres and networks in Europe. The Finnish Investigators Network for Pediatric Medicines, FINPEDMED, established in 2007, was the first national paediatric network in northern Europe. It is currently the only NOrdic full member of the European Network of Paediatric Research at EMA (Enpr-EMA). A Norwegian pediatric research network (NorPedMed) was established in 2013. NorPedMed was developed in close collaboration with FINPEDMED and the
networks share many practices and tools. In the other Nordic countries, such national networks do not currentky exist, but particulary in Sweden discussion on a paediatric network are taking place.

Paediatric clinical trials are commonly conducted as multicentre and multinational studies. From the pharmaceutical industry's point of view, the paediatric population of individual nordic countries may be too small to be really interesting for such studies. The network collaboration of the Nordic countries can substantially increase to that available to Networks of large European countries. A Nordic network can hold a stronger position within Enpr_EMA and in discussions with the pharmaceutical industry than national networks. Nordic countries share many unique competitive advantages, which can be innovatively utilized through collaboration for a more important role in Europe in the area of paediatric medicines research.