Periodic Reporting for period 3 - PedCRIN (Paediatric Clinical Research Infrastructure Network)
Reporting period: 2020-01-01 to 2021-06-30
Children’s health is a major societal challenge for Europe and the world, over 50 % of the medicines used for children had not been tested in this specific age group. Conducting clinical trials in children requires specific competences and infrastructures. The PedCRIN project, coordinated by ECRIN-ERIC (www.ecrin.org) was funded by H2020 (INFRADEV-3 call 2016, 3.3M€) to strengthen the capacity of ECRIN to support paediatric trials, in particular investigator-initiated trials, in close cooperation with the paediatric patients and the paediatric clinical research community. This followed an ESFRI application for a European infrastructure for paediatric trials (EPCTRI), resulting in a recommendation on the ESFRI roadmap 2016 that EPCTRI and ECRIN explore the potential to align their efforts at strategic and operational level. The PedCRIN project builds on six work packages: Project management & coordination (WP1), sustainability of PedCRIN outcomes, to ensure optimal maintenance of the organization, tools, and services beyond the end of the PedCRIN (WP2), development tools for paediatric and neonatal trials (WP3), conduct of three pilot paediatric trials (WP4), communication, dissemination, empowerment (WP5) and ethics requirements (WP6).
The PedCRIN project aimed to broaden the operational capabilities of ECRIN, by connecting to new clinical trial units with paediatric expertise, thus developing its capacity to design, plan and manage multinational paediatric trials, and by attracting new users’ communities able to design multinational neonatal and paediatric trials. The PedCRIN project has provided a unique opportunity for ECRIN to improve its business model and financial sustainability, attracting more industry-sponsored trials and more Member and Observer countries. In terms of expansion, two countries participating in the PedCRIN consortium decided to join ECRIN: Ireland in November 2018 and Poland in August 2019. In addition, Czech Republic, already an Observer, became a Member in January 2018. All have paediatric expertise in terms of trial management and investigation.
The PedCRIN project aimed to broaden the operational capabilities of ECRIN, by connecting to new clinical trial units with paediatric expertise, thus developing its capacity to design, plan and manage multinational paediatric trials, and by attracting new users’ communities able to design multinational neonatal and paediatric trials. The PedCRIN project has provided a unique opportunity for ECRIN to improve its business model and financial sustainability, attracting more industry-sponsored trials and more Member and Observer countries. In terms of expansion, two countries participating in the PedCRIN consortium decided to join ECRIN: Ireland in November 2018 and Poland in August 2019. In addition, Czech Republic, already an Observer, became a Member in January 2018. All have paediatric expertise in terms of trial management and investigation.
During the reporting period the PedCRIN consortium achieved significant results and the project developed as planned. WP1 and WP2 established a sustainability board including government representatives and plan the strategy for sustainability based on the users’ community needs. WP4 completed the access to transnational clinical trial management services for the PedCRIN funded pilot neonatal or paediatric multinational trials. The current ECRIN tools were enriched with paediatric and neonatal tools for the setup and management of multinational paediatric and neonatal clinical trials (WP3). Access of these tools on PedCRIN website was provided along with the scientific publications by WP3 were done in order to reach the scientific and users’ communities to collect external feedback regarding the validity, reliability, and utility of the tools for end users. A dynamic campaign was performed by WP5 to communicate and disseminate about PedCRIN project and its outcomes with children, parents and families, industry, regulatory authorities, policymakers, healthcare providers and all the relevant stakeholders. This included newsletters, several mailings, communications to the main paediatric research institutions, a social media campaign (Facebook, Twitter, and LinkedIn) and a hashtag, which could be followed through the PedCRIN social media: #FIPCR21. Moreover, Series of webinars were organised by WP5 involving the experts implicated in the creation of the tools (WP3) to communicate, educate, and train on these tools to the clinical investigators, researchers and medical professionals interested in conducting paediatric and neonatal clinical research. For the effective coordination of the project and to ensure the coordination and monitoring of the activity of the WPs, regular steering committee, advisory board, general assembly, and clinical trial follow-up meetings including the users (PIs and sponsors) were organized under WP1. All the activities of the project were performed in compliance with the European Commission’s H – Requirement No and POPD requirement No.2 under WP6.
The PedCRIN Sustainability Board defined long-term perspectives for the partnership with the paediatric investigation networks and the sustainability of the tools developed during the PedCRIN project. In addition, this model can be generalized to partnership between ECRIN and investigator community in any disease area. The resulting sustainability plan is based on four main objectives
o promoting full alignment of European paediatric clinical research with the European medical research infrastructure landscape through a stable partnership with ECRIN for clinical research, and with the other partners of the Alliance of Medical Research Infrastructures (AMRI), namely BBMRI and EATRIS, as well as with the Biological and Medical Science Research Infrastructures (BMS-RI) cluster.
o promoting integration of the paediatric community into the broad spectrum of partnerships with medical specialities when appropriate, thus fostering cross-fertilization and sharing of tools and methodologies, while enabling the adaptations required to meet the needs of children and young people, as recognized by the Paediatric Regulation* and across society, for example in education and health care.
o avoiding unnecessary overlap of organisations, tools and services within the publicly funded research ecosystem
o establishing a stable partnership at operational and governance levels to ensure efficient coordination and optimal use of resources and competencies between ECRIN, the children and the paediatric community.
The sustainability plan therefore includes long-term commitments on
o The distribution of roles in the operational support to European paediatric trials between ECRIN and the European paediatric investigation network, including children and families.
o The distribution of roles in the maintenance of tools developed by PedCRIN, which includes trial management tools as well as investigation tools.
o The need for resources at core and national level
o The expansion of ECRIN towards countries participating in PedCRIN
o The governance and partnership agreement
*Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
o promoting full alignment of European paediatric clinical research with the European medical research infrastructure landscape through a stable partnership with ECRIN for clinical research, and with the other partners of the Alliance of Medical Research Infrastructures (AMRI), namely BBMRI and EATRIS, as well as with the Biological and Medical Science Research Infrastructures (BMS-RI) cluster.
o promoting integration of the paediatric community into the broad spectrum of partnerships with medical specialities when appropriate, thus fostering cross-fertilization and sharing of tools and methodologies, while enabling the adaptations required to meet the needs of children and young people, as recognized by the Paediatric Regulation* and across society, for example in education and health care.
o avoiding unnecessary overlap of organisations, tools and services within the publicly funded research ecosystem
o establishing a stable partnership at operational and governance levels to ensure efficient coordination and optimal use of resources and competencies between ECRIN, the children and the paediatric community.
The sustainability plan therefore includes long-term commitments on
o The distribution of roles in the operational support to European paediatric trials between ECRIN and the European paediatric investigation network, including children and families.
o The distribution of roles in the maintenance of tools developed by PedCRIN, which includes trial management tools as well as investigation tools.
o The need for resources at core and national level
o The expansion of ECRIN towards countries participating in PedCRIN
o The governance and partnership agreement
*Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004