Meeting on Nordic network for clinical trials – NordicPedMed

NTA supported in 2014 and 2016 the creation of a Nordic network for pediatric clinical studies. After summoning all Nordic countries in a common network, the first meeting was undertaken 13 June 2017 in Helsinki and close to 70 participants attended.   Professor Kalle Hoppu presents NordicPedMed during the network meeting.

Many speakers reported on the lack of knowledge when using drugs developed for adults in children. In the EMA process for accepting new drug treatments, a pediatric investigational plan (PIP) is mandatory. Despite close to 1000 such PIPs established, only a fraction turns into real world evidence for use in children.

The main obstacle is to find centers where such studies can be done. In mean, patient recruiting for an ordinary study follow agreed estimates in only 30% of the centers. It has been shown that with an infrastructure (network) supporting the centers, estimated inclusion rate is reached by 80% of the centers.

The meeting also reported on the need for a common Nordic ethical approval to support these studies, to provide clinical evidence as fast as possible as reults can be achived earlier by so doing. Free patient movement over borders to access personalised clinical studies was also mentioned.