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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:


To set up drug prioritisation and

enable drug development, based on the

mechanism of action of the drug as well

as biological factors;


To propose changes in the EU Paediatric

Medicine Regulation to better address

the needs of those with life threatening



To propose new incentives for the

development of specific paediatric drugs

and repurposing of existing drugs;


To implement long-term follow up

measures for new oncology drugs for

children and adolescents.

Ethics, Social Sciences and Humanities


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


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).