33 / 49
Multi-stakeholder platform for new
paediatric oncology drug development –
The CDDF-SIOPE-ITCC platform
Thismulti-stakeholder platformwas created in
December 2013 by Cancer Drug Development
Forum (CDDF), SIOPE and ITCC as a deliverable
of theENCCAproject toimproveoncologydrug
development for children and adolescents
[8]. Academia, parents and survivors, industry
and regulators are equally represented and
work together on the following objectives:
g
To set up drug prioritisation and
enable drug development, based on the
mechanism of action of the drug as well
as biological factors;
g
To propose changes in the EU Paediatric
Medicine Regulation to better address
the needs of those with life threatening
diseases;
g
To propose new incentives for the
development of specific paediatric drugs
and repurposing of existing drugs;
g
To implement long-term follow up
measures for new oncology drugs for
children and adolescents.
Ethics, Social Sciences and Humanities
programme
This is a natural development of the ethics
programme set-up within ENCCA to maintain
and improve the level of expertise on ethics
in the field of paediatric cancer care and
research. It is based on two priorities, namely
to reflect the multidisciplinary nature of social
sciences and humanities where suitable to
paediatric oncology, and to facilitate access to
appropriate expert views from professionals
and from patients’ representatives on ethical
issues.
Following these priorities, “ethics” is meant
as a multidisciplinary approach to the
non-technical issues related to the care,
protection, and self-realisation of paediatric
oncology-haematology patients (or former
patients). It is proposed to develop a non-
prescriptive, participatory and outcomes-
oriented approach to these issues, harnessing
the relevant knowledge and expertise in the
Social Sciences and Humanities (SSH) field.
Four main topics will be addressed by this
programme: i) return of research results,
ii) personal data in care and research
environments, iii) access to medical inno-
vation, iv) care and healthcare pathways.
The programme will be performed through
objective assessment of the non-technical
issues related to the care and quality of
survival of children and adolescents with
cancer, as well as through community-based
participatory research actions within the
paediatric oncology community.
In accordance with the successful imple-
mentation within ENCCA, the programme
will be steered and run by a permanent
contact point along with ad-hoc academic
collaborations. A steering Legal and Ethical
Advisory Board will peer-review the projects
and the results. The following tools will be set
up: i) a thematic database of ethics expertise
in Europe, identifying expert individuals and
centres in Western and Eastern European
Universities, ii) a database of local initiatives
for bedside andbenchsideethics, accessible to
professionals and patients, iii) an initiative to
establish multi-centre collaborations on non-
technical interventions (fostering experience-
sharingand multicentre evaluation).
33
A EUROPEAN CANCER PLAN FOR CHILDREN AND ADOLESCENTS