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PedCRIN SIGNED

Paediatric Clinical Research Infrastructure Network

Total Cost €

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EC-Contrib. €

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Partnership

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 PedCRIN project word cloud

Explore the words cloud of the PedCRIN project. It provides you a very rough idea of what is the project "PedCRIN" about.

empowerment    wp3    strategies    ing    sponsored    group    quality    wp2    ecrin    few    packages    disease    area    landmarks    reporting    pilot    world    age    conducting    attracting    neonatal    monitoring    capacity    wp5    ethical    multinational    methodology    safety    trials    opportunity    uncritical    establishment    plan    infants    transnational    efficacy    suggested    societal    bio    treatments    countries    adverse    extrapolation    certification    adult    org    updated    event    parents    patient    cooperation    scientific    tested    wp1    communication    esfri    eatris    competences    government    policymakers    database    builds    demonstrating    requiring    governance    clinical    model    data    strategy    communities    financial    tools    jointly    children    had    roadmap    sustainability    bbmri    health    observer    pedcrin    business    industry    eric    board    2016    organisation    outcome    upgrade    wp4    paediatric    epctri    medicines    trial    regulatory    infrastructure   

Project "PedCRIN" data sheet

The following table provides information about the project.

Coordinator
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK 

Organization address
address: 5 RUE WATT
city: PARIS
postcode: 75013
website: www.ecrin.org

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 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

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) coordinator 1˙560˙125.00
2    THE UNIVERSITY OF LIVERPOOL UK (LIVERPOOL) participant 325˙875.00
3    VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES NL (SOEST) participant 185˙625.00
4    FUNDACIO SANT JOAN DE DEU ES (Esplugues de Llobregat) participant 178˙125.00
5    HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ FI (HELSINKI) participant 178˙125.00
6    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE FR (PARIS) participant 178˙125.00
7    STICHTING KATHOLIEKE UNIVERSITEIT NL (NIJMEGEN) participant 178˙125.00
8    CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE IT (BARI) participant 170˙625.00
9    ARISTOTELIO PANEPISTIMIO THESSALONIKIS EL (THESSALONIKI) participant 48˙750.00
10    HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL NO (BERGEN) participant 48˙750.00
11    KAROLINSKA INSTITUTET SE (STOCKHOLM) participant 48˙750.00
12    OKIDS GMBH AT (WIEN) participant 48˙750.00
13    SWISS CLINICAL TRIAL ORGANISATION CH (BERN) participant 48˙750.00
14    TARTU ULIKOOL EE (TARTU) participant 48˙750.00
15    THE NATIONAL CHILDREN'S RESEARCH CENTRE IE (DUBLIN) participant 48˙750.00

Map

 Project objective

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.

 Deliverables

List of deliverables.
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.

 Publications

year authors and title journal last update
List of publications.
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.

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