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g
There is a lack of sustained and sufficient funding, with high levels of competition for
funding and need for prioritisation.
g
Healthcare professionals struggle to run investigator-driven clinical trials since the entry into
force of the driven EU Clinical Trial Directive (2001/20/EC) in 2004.
Although the new EU Clinical Trial Regulation (536/2014/EU) may facilitate academic
research when it will be implemented (in 2016), however, it will not address all the existing
challenges.
g
There is still poor access to new paediatric drugs in Europe, despite the EU
Paediatric Medicine Regulation (1901/2006/EC and 1902/2006/EC) – which nevertheless
changed the landscape of childhood cancer drug development in Europe.
g
There is insufficient integration between basic biology and clinical research, although
there have been several successful EU projects (including KidsCancerKinome, EET-pipeline,
ChildHope) funded within the 5th and 6th Framework Programmes.
g
There are considerable disparities in Europe in the implementation of research (clinical,
translational and basic) and in access to standard care, in particular for TYA.
g
Paediatric haematology-oncology is not recognised as a sub-specialty in most countries.
g
Parents, patients and survivors’ organisations lack tools and
platforms to better join forces with all stakeholders.
g
A certain level of fragmentation of research remains, in
spite of a long history of networking and major efforts
to build together a common infrastructure.
g
Paediatric haematology-oncology has grown and achieved
successes so far in relative isolation in comparison with the
adult oncology community.
Weaknesses
g
The availability of high-throughput technologies that can quickly deal with large numbers of
samples will allow new breakthroughs in understanding paediatric tumour biology.
g
The development of effective innovative therapies (such as targeted agents and
immunotherapy) in adult cancers should be applicable to the treatment of paediatric
tumours.
g
Paediatric haematology-oncology is now part of the EU agenda, as illustrated by ENCCA – a
FP7 network of excellence structuring paediatric cancer research in Europe – and
ExPO-r-Net, a DG SANTE project piloting the concept of European Reference Networks ERN)
within the scope of the EU Cross-Border Healthcare Directive (2011/24/EU).
Opportunities
13
A EUROPEAN CANCER PLAN FOR CHILDREN AND ADOLESCENTS
Credit Sociedade de Hemato-Oncologia Pediátrica
(SHOP), Portugal