Explore the words cloud of the PedCRIN project. It provides you a very rough idea of what is the project "PedCRIN" about.
The following table provides information about the project.
Coordinator |
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
Organization address contact info |
Coordinator Country | France [FR] |
Project website | http://www.pedcrin.org |
Total cost | 3˙296˙000 € |
EC max contribution | 3˙296˙000 € (100%) |
Programme |
1. H2020-EU.1.4.1.1. (Developing new world-class research infrastructures) |
Code Call | H2020-INFRADEV-2016-1 |
Funding Scheme | CSA |
Starting year | 2017 |
Duration (year-month-day) | from 2017-01-01 to 2020-12-31 |
Take a look of project's partnership.
Children’s health is a major societal challenge for Europe and the world, requiring development of paediatric medicines and treatments strategies based on evidence derived from clinical trials demonstrating efficacy and safety in infants and children, rather than on uncritical extrapolation from adult data (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 infrastructure. ECRIN-ERIC (www.ecrin.org) is a generic infrastructure for multinational trial management, in any disease area. However it does not specifically address the paediatric needs in terms of trial management capacity. In its 2016 Roadmap, ESFRI suggested an upgrade of ECRIN to develop a common infrastructure for paediatric trial management through cooperation with the European Paediatric Clinical Trial Research Infrastructure (EPCTRI). The resulting PedCRIN project is also a unique opportunity to improve ECRIN business model and financial sustainability, attracting more industry-sponsored trials and more Member and Observer countries.
PedCRIN builds on five work packages : project coordination (WP1); establishment of a strategy and upgrade of the governance and business plan, through a Sustainability Board jointly involving the scientific partners and the government representatives (WP2); development of tools specific for paediatric and neonatal trials (WP3) (methodology, outcome measures, adverse event reporting, bio-sample management, ethical and regulatory database, monitoring, quality and certification); operational support provided as transnational access to a few pilot trials to test the updated organisation and tools (WP4); communication targeting user’s communities (including industry), policymakers, patient and parents’ empowerment (WP5). Two other ESFRI-landmarks, BBMRI-ERIC and EATRIS ERIC, will contribute to PedCRIN.
Project newsletters 5 | Documents, reports | 2020-02-27 11:41:24 |
Project newsletters 4 | Documents, reports | 2020-02-27 11:41:24 |
Procedure for access to individual patient clinical trial data | Documents, reports | 2020-02-27 11:41:23 |
Advisory Board report 1 | Documents, reports | 2020-02-27 11:41:23 |
Composition of Scientific Board | Documents, reports | 2020-02-27 11:41:23 |
Cost evaluation for the selected trials | Documents, reports | 2020-02-27 11:41:23 |
Project newsletters 2 | Documents, reports | 2020-02-27 11:41:23 |
Communication and Dissemination Plan | Documents, reports | 2020-02-27 11:41:23 |
Press releases and factsheet | Documents, reports | 2020-02-27 11:41:24 |
Specification of the call | Websites, patent fillings, videos etc. | 2020-02-27 11:41:23 |
Gap analysis based on survey data | Documents, reports | 2020-02-27 11:41:23 |
Logo and Brochure | Documents, reports | 2020-02-27 11:41:23 |
Interim report | Documents, reports | 2020-02-27 11:41:23 |
Criteria for projects selection | Documents, reports | 2020-02-27 11:41:23 |
Report on patient engagement and perspective integration | Documents, reports | 2020-02-27 11:41:24 |
Procedure for patient level data sharing | Open Research Data Pilot | 2020-02-27 11:41:23 |
Survey on infrastructure and service needs for paediatric and neonatal trials | Websites, patent fillings, videos etc. | 2020-02-27 11:41:22 |
Project newsletters 3 | Documents, reports | 2020-02-27 11:41:24 |
Project newsletters 1 | Documents, reports | 2020-02-27 11:41:23 |
Project Website | Websites, patent fillings, videos etc. | 2020-02-27 11:41:23 |
Advisory Board report 2 | Documents, reports | 2020-02-27 11:41:24 |
Take a look to the deliverables list in detail: detailed list of PedCRIN deliverables.
year | authors and title | journal | last update |
---|---|---|---|
2019 |
Eric Vermeulen, Kim Karsenberg, Johanna H. Lee, Saskia N. Wildt Involve Children and Parents in Clinical Studies published pages: 11-13, ISSN: 1752-8054, DOI: 10.1111/cts.12696 |
Clinical and Translational Science 13/1 | 2020-03-05 |
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The information about "PEDCRIN" are provided by the European Opendata Portal: CORDIS opendata.