Ethical aspects in Pediatric Clinical Trials - Nordic Advantages Joint NordicPedMed / PIF Conference

Transcription

1 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

2 Outline Enpr-EMA Ethics Working Group -> pragmatic deliverables FINPEDMED IC Materials & Nurse Training program NORDICPEDMED Nordic ethics collaboration work YPAGs - Future Trends & Prospects PL 2

3 Enpr-EMA Ethics Working Group -> pragmatic deliverables

4 EMA Home ( ) -> Partners & Networks -> Networks -> An agency of the European Union

5 Enpr-EMA Working Groups (under Activities) 5

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8 EnprEMA Working Groups - WG4 Ethics; Dialogue and Interaction with Ethics Committees An agency of the European Union

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10 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

11 Deliverables First Report: Plan Report - Recommendations (12), published in December 2013 for Enpr-EMA CG (only) 11 EMA

12 WG4-1. Task 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 Article: Informed Consent and Assent Tool Kit for Paediatric Clinical Trials in Europe ; 25 May 2016, Arch Dis Child 2016

13 1. Deliverable; The Tool Kit EMA Home ->Partners & Networks ->Networks ->Enpr-EMA ->Enpr-EMA activities 13

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15 15 Continues: 27 EEA EU MSs

16 1. Article; About the Tool Kit (2016) 16

17 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 ( )! 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

18 WG4 2. Task in Deliverable; Public Consultation of the Ethical considerations for clinical trials on medicinal products conducted with the paediatric population (2008), submitted 30 August 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

19 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

20 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

21 21 TEMPLATE PAGES 1-3 as an example of the content (6 pages total)

22 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

23 WG4 collaboration with EUREC - European Network of Research Ethics Committees (2017 ->) EUREC-ANCEI Congress in Barcelona 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

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25 FINPEDMED IC Materials & Nurse Training program

26 FINPEDMED: IC template models (2009) Press Release PL 26

27 Example of the IC 6-10 years (will be revised after CT Reg.) PL 27

28 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 PL 28

29 Finpedmed Picture Cards PL

30 Pediatric Research Nurse Training Program; 4 Credits o Pilot 2015 o o Completed in 3 University Hospitals Certificates for 30 Research Nurses PL 30

31 Ethical conciderations in the curriculum PL 31

32 NORDICPEDMED Nordic ethics collaboration work

33 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 PL 33

34 NTA WP1 Report ( PL 34

35 Mika Scheinin, , NTA Oslo PL 35

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39 YPAGs - Future trends & prospects

40 Future Trends & Prospects: e-consents PL 40

41 YPAGs and e-technology With young experts: PL 41

42 National YPAGs Nordic area needs own groups PL 42

43 YPAG Young Persons Advisory Groups GenerationR, UK: / ScotCRN, Scotland: ican, U.S /global: ican/kids, Spain: ican/kids, France: KidsCan, Canada: ican/kids, Australia: PL 43

44 KiDS Barcelona Sant Joan de Déu (2017) example of YPAG activities PL

45 eypagnet Global network - connections PL 45

46 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 HUS, Finland Office: University of Tampere, School of Medicine Tampere Center for Child Health Research ARVO building, Lääkärinkatu 1, Room D519 FI University of Tampere, Finland P: PL 46