Update ENCCA project

Sabine Karner, Project worker, CCI

Jean-Claude Dupont, Philospher, Institut Curie

6th CCI Europe Regional Meeting

9th of May 2015, Malmö (Sweden)

• To efficiently structure and enhance collaboration within the field of paediatric oncology in Europe.

• Bringing together all relevant stakeholders, their expertise and viewpoints

• Propose a Virtual European Institute for Cancer Research in Children and Adolescents

Aim of ENCCA

European Network for Cancer research in

Children and Adolescents

34 Partners - 11 European Countries-

18 Workpackages – 85 Milestones –

80 Deliverables

Duration: January 2011

till December 2015

Structure

of ENCCA

Workpackages involved

WP2A European Sustainable

Strategy for Clinicaland Translational

Research

WP4

Facilitation of Clinical Trials

WP13Quality of

survivorship

WP14Dissemination

activities

WP 5Biology to guide

Innovative targetedtherapy development

WP12Clinical research

in very rare tumours

WP15Education &

Training

WP17Teenager &

Young adults

WP18Ethics

Sunday

PPAC

Liver Tumour Forum

Jean-Claude

Dupont

Parents and Patients Advoacy Committee (PPAC)Who Parent organisation/Survivor representative Country

ARNOLD Frederic UNAPECLE France

BASSET Luisa FEPNC - Federacion Española de padres de Niños con Cáncer Spain

KAMERIĆ Lejla The heart for the kids with cancer in FBiHBosnia and Hercegovina

KAMERIĆ Neira The heart for the kids with cancer in FBiH/Cancer Survivor NetworkBosnia and Hercegovina

KIENESBERGER Anita Österreichische Kinder-Krebs-Hilfe Austria

LACK Peter Kinderkrebshilfe Schweiz Switzerland

TSIROU Aimilia Kyttaro/Greek Survivors Association Greece

Advisors:

BODE Gerlind Förderkreis für krebskranke Kinder und Jugendliche Bonn e.V. Germany

NAAFS-WILSTRA Marianne VOKK Netherlands

Project worker:

KARNER Sabine Österreichische Kinder-Krebs-Hilfe Austria

Workpackages involved

WP2A European Sustainable

Strategy for Clinicaland Translational

Research

WP4

Facilitation of Clinical Trials

WP13Quality of

survivorship

WP14Dissemination

activities

WP 5Biology to guide

Innovative targetedtherapy development

WP12Clinical research

in very rare tumours

WP15Education &

Training

WP17Teenager &

Young adults

WP18Ethics

Sunday

PPAC

Jean-Claude

Dupont

Liver Tumour Forum

“A Guide to Clinical Trials” – for parents and young people

• English/German/Spanish version is done and online available as a pageflip(www.icccpo.org)

• Other translations will follow

• “Information sheet for translation and publication”

• Printed versions available (English, German)

Information about clinical trials and

training courses for parents/patients/

survivors representativeswww.icccpo.org

Patient/Family Forumfor liver tumours in children

A virtual community for patients and families to:

• Share experiences with other parents/patients/survivors

• Gain disease information

• Give each other collaborative support

WP 12: Clinical research in very rare

tumours

How to access the forum: http://www.siopel.org

Click here to register

Patients/Families Forum

• Collaboration with Institut Curie – Jean-Claude Dupont (philospher)

• Guidelines on confidentiality issues regarding human tissues, cells, DNA, sera and collected protein (ongoing)

• Guidelines on clinical trials in paediatric oncology (ongoing)

• Description of discrepancies in Europe (this year)

• Keep developing training interventions

WP 18: Ethics

Report on ENCCA WP18why ENCCA experience is meaningful on ethics?

Not a work on, nor a study about; empirical surveys are key, but ENCCA = P.O. community at work for its own purposes

A real cooperation and involvement from representatives of parents, patients and professionals

A lesson? Community dialogue produces meaningful results, provided it is informed

Work with representatives

40+ oral presentations5 international congresses3 international courses (without mentioning Sabine Karner, Anita Kienesberger, and François Doz activities)

Knowledge-based ethics

Apply methods to literature review and community deliberation in ethics to P.O.

Outcomes in ENCCA:

1. Scoping and overview diversity of ethical issues ex. clinical trials, design, access (not only consent)

2. To inform and conduct community dialogue following up-to-date methodologies, BUT community members decide ex. biobanks, re-consent after 18

3. Generate knowledge and meta-research conduct systematic literature reviews

Broaden perspective

A network of excellence = NOT a collection of WPs

Ethics expertise, available and dedicated to P.O. community knowledge (ethicist) AND deliberation (stakeholders)

Synergies along the ENCCA project:1. Unplanned collaborations on stakeholders’ initiative

ex. fertility preservation, TYAs, late-effects

2. Apply knowledge and stakeholders’ inputs (“short route”) ex. biobanks: consent (Curie, ÖKKH), fate of samples

3. Raise unexpected topics (ethical watch) ex. data “ownership” (?) in survivorship passport

The (expected) futurewhat is envisioned in PICORET?

The vision

PICORET consortium aims: “to reduce the disparities in childhood cancer survival seen across Europe and contribute to improved survival rates and quality of life for cancer survivors.” to measure, and ultimately to improve, outcomes involves key and currently unfixed data issues (genetics, linking clinical data and cancer registries)

A WP10 on Data Privacy and ethical issues. Partners are: Institut Curie, CCI/OKKH, Hannover/LUH, and IARC

The proposed approach is……non-prescriptive ethics & law provide accurate information

…participatory 2 key tasks led by patients’ representatives / CCI

…outcomes-oriented 1 task evaluation, 2 tasks PICORET policies

The plan

WP10 leader: Pr. François Doz, Institut Curie

Task 10.1 Monitoring and evaluation of ethical and legal interventions. OKKH

Task 10.2 Ethical aspects and social values tied to data research uses. CURIE

Task 10.3 Legal review on European and domestic rules in data law. LUH

Task 10.4 A consent toolkit for the PICORET consortium. OKKH

Task 10.5 A “return of research results” policy for the PICORET consortium. CURIE

Task 10.6 Helpdesk and ongoing support on law and ethics for all partners. LUH

Comparative approach, special focus on Eastern Europe

ENCCA-PICORET complementarity

PICORET……towards a sustainable implementation of partnerships on ethics built in ENCCA

1. 2 community-based participatory research actions

2. Service and support to the P.O. community

3. Legal Ethical Advisory Board already constituted

4. Academic networking for multidisciplinary and local cooperation

Two additional priority topics might be relevant if we can build from ENCCA a durable cooperation on ethics and SSH:

1. Access to medical innovation (in- or off- clinical trials)

2. Care and healthcare pathways (care + health policies issues)

Take-home messages

In a sustainable network/virtual institute:1. Stakeholders have much to share than experience: a real expertise

2. Ethicist provides methodologies for informed community dialogue

3. P.O. community masters agenda and defines interventions

Community benefits in durable cooperation on ethics:1. Service and support to the community (articulation with SSH)

2. Training and capacity-building (community deliberations)

3. Evidenced non-technical interventions (multicentre + evaluation)

Stakeholders’ expertise + knowledge generation are both highly relevant in view to inform policy-making