www.finpedmed.fi www.finpedmed.com Ethical aspects in Pediatric Clinical Trials - Nordic Advantages Joint NordicPedMed / PIF Conference 13 June.2017, Helsinki Pirkko Lepola Executive Secretary of FINPEDMED General Secretary of NORDICPEDMED Helsinki University Hospital, Department of Children and Adolescents, Digital and Innovation Services Helsinki, Finland
Outline Enpr-EMA Ethics Working Group -> pragmatic deliverables FINPEDMED IC Materials & Nurse Training program NORDICPEDMED Nordic ethics collaboration work YPAGs - Future Trends & Prospects 9.6.2017 PL 2
Enpr-EMA Ethics Working Group -> pragmatic deliverables
EMA Home (http://www.ema.europa.eu ) -> Partners & Networks -> Networks -> An agency of the European Union
Enpr-EMA Working Groups (under Activities) 5
6
7
EnprEMA Working Groups - WG4 Ethics; Dialogue and Interaction with Ethics Committees An agency of the European Union
9
Working group 4 - Ethics Structure 2017 o o o o o o o o o o Pirkko Lepola, Chair (Finnish Investigators Network for Pediatric Medicines, Helsinki, Finland) Maxine Kindred, (Janssen Research & Development, Buckinghamshire, UK) Diane Hoffman, (Janssen Research & Development, Philadelphia, U.S.A.) Martine Dehlinger-Kremer (SynteractHCR Deutschland GmbH, Munich, Germany) Jo Mendum (PRA HealthSciences, Reading, UK) Peter Sallabank (RegulinX, Surbiton, UK) David Neubauer (University Children s Hospital, Ljubljana, Slovenia) Christina Manfredi (CVBF-Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy) Viviana Giannuzzi (Fondazione per la Ricerca Farmacologica Gianni Benzi, Valenzano, Italy) Heidi Glosli (Oslo University Hospital, NorPedMed, Oslo, Norway) 10
Deliverables First Report: Plan Report - Recommendations (12), published in December 2013 for Enpr-EMA CG (only) 11 EMA
WG4-1. Task 2014-2015 1. Deliverable; Tool Kit - Informed Consent and Assent for Paediatric Clinical Trials in Europe o Published on Enpr-EMA web-site on 18 December 2015 o Will be updated by the Enpr-EMA Secretariat http://www.ema.europa.eu/docs/en_gb/document_library/other/2015/12/wc500199234.pdf 12 1. Article: Informed Consent and Assent Tool Kit for Paediatric Clinical Trials in Europe ; 25 May 2016, Arch Dis Child 2016
1. Deliverable; The Tool Kit EMA Home ->Partners & Networks ->Networks ->Enpr-EMA ->Enpr-EMA activities 13
14
15 Continues: 27 EEA EU MSs
1. Article; About the Tool Kit (2016) 16
Results Terms consent and assent are interpreted differently in legal texts between EEA countries In EEA countries, 18 years generally the legal age for independent consent - exceptions; 14 Austria, 15 Finland and Denmark, 16 UK 32 different age groupings (0- - -18)! 3 countries (Croatia, Lithuania and Slovakia) without spesific age groups for consent / assent Different definitions for legal consent and the requirement of legal signatures; criteria are not uniformly defined in European guidelines or recommendations (unknown reasons) 17
WG4 2. Task in 2016 2. Deliverable; Public Consultation of the Ethical considerations for clinical trials on medicinal products conducted with the paediatric population (2008), submitted 30 August 2016. o Contributed by EFGCP CMWP (European Forum for Good Clinical Practice, Children s Medicines Working Party; WP 1, In collaborating with a small group of EMA PDCO members o New Guideline will be published before summer! 18
WG4-Task 3:Uniform IC / Assent template (2017) Background facts: 1. New EU CT Reg. (impl.approx.10/2018) will harmonise clinical trial application (CTA) process, but IC/Assent issues remain with each Member State 2. There are noticeable differences between national IC and assent requirements in Europe due to national laws and regulations (See: Tool Kit data) These discrepancies present challenges for multicentre paediatric CTs 19
WG4 - Task 3: Uniform IC/ Assent template 3. Deliverable: Partly harmonized of Informed Consent / Assent template -document : Consent group o Based on identification of all similar elements across assents / consents of existing templates o 1. version published on Enpr-EMA Annual Workshop, 16 May 2017 20
21 TEMPLATE PAGES 1-3 as an example of the content (6 pages total)
TASK 3 Continuation (2017) YPAG Group KiDS Barcelona: Template model review & comments & proposal By the end of August 2017 Free hands for comments of the template model New ideas how the information should be presented in a childfriendly way to increase understanding Ideas & proposals for the visualization of the document 22
WG4 collaboration with EUREC - European Network of Research Ethics Committees (2017 ->) EUREC-ANCEI Congress in Barcelona 17.-19.May2017 Presentation Enpr-EMA/WG4 on 18may New co-wg by Enpr-EMA and EUREC will be established -> new ideas for collaboration Survey on needs and expectations among EUREC members. 23
24 http://www.eurecnet.org/news
FINPEDMED IC Materials & Nurse Training program
FINPEDMED: IC template models (2009) Press Release 9.6.2017 PL 26
Example of the IC 6-10 years (will be revised after CT Reg.) 9.6.2017 PL 27
FINPEDMED: Picture Cards (2008) Designed by a group of experts and a graphic designer Children (ages 1 to 6) commented -> modified to better suit the objects Labelled in Finnish, Swedish and English. The picture cards are under copyright law 2009 Exist in printed form sized A6, in a folder sized A5 31 picture cards, abstracts and transparent No-card 9.6.2017 PL 28
Finpedmed Picture Cards 9.6.2017 29 PL
Pediatric Research Nurse Training Program; 4 Credits o Pilot 2015 o o Completed in 3 University Hospitals 2015-2017 Certificates for 30 Research Nurses 9.6.2017 PL 30
Ethical conciderations in the curriculum 9.6.2017 PL 31
NORDICPEDMED Nordic ethics collaboration work
NTA Projects WP1 - Ethical Review Process for Clinical Trials in the Nordic Countries For more information please contact Mika Scheinin, MD, Dr. Med. Sci., Chair Nordic Trial Alliance Working Group on Ethics, at mschein@utu.fi 9.6.2017 PL 33
NTA WP1 Report ( 9.6.2017 PL 34
Mika Scheinin, 30.1.2017, NTA Oslo 9.6.2017 PL 35
9.6.2017 PL 36
9.6.2017 PL 37
9.6.2017 PL 38
YPAGs - Future trends & prospects
Future Trends & Prospects: e-consents 9.6.2017 PL 40
YPAGs and e-technology With young experts: 9.6.2017 PL 41
National YPAGs Nordic area needs own groups 9.6.2017 PL 42
YPAG Young Persons Advisory Groups GenerationR, UK: http://generationr.org.uk/about / ScotCRN, Scotland: http://www.scotcrn.org/young-people/ ican, U.S /global: http://www.icanresearch.org/ ican/kids, Spain: http://www.icanresearch.org/barcelona/ ican/kids, France: http://ripps.eu/en/the-french-andeuropean-networks/kids-france/events-kids-france/ KidsCan, Canada: http://www.cfri.ca/kidscan/home ican/kids, Australia: http://www.schn.health.nsw.gov.au/ 9.6.2017 PL 43
KiDS Barcelona Sant Joan de Déu (2017) example of YPAG activities 44 9.6.2017 PL
eypagnet Global network - connections 9.6.2017 PL 45
Contact details Pirkko Lepola Executive Secretary FinPedMed Finnish Investigators Network for Pediatric Medicines General Secretary NordicPedMed Nordic Investigators Network for Pediatric Medicines Helsinki University Hospital, Department of Children and Adolescents, Digital and Innovation Services Lastenlinnantie 2, Helsinki P.O.Box 280, FI-00029 HUS, Finland e-mail: pirkko.lepola@hus.fi Office: University of Tampere, School of Medicine Tampere Center for Child Health Research ARVO building, Lääkärinkatu 1, Room D519 FI-33014 University of Tampere, Finland P: +358-50-5142646 e-mail: pirkko.lepola@uta.fi www.finpedmed.fi www.nordicpedmed.com 9.6.2017 PL 46