conect4children (COllaborative Network for European Clinical Trials For Children)

akronüüm: c4c
algus: 2018-05-01
lõpp: 2024-04-30
 
programm: H2020 - Horisont 2020
alaprogramm: HEALTH - Tervishoid, demograafilised muutused ja heaolu
instrument: JTI-IMI2-RIA
projektikonkurss: H2020-JTI-IMI2-2016-10-two-stage
projekti number: 777389
kestus kuudes: 72
partnerite arv: 47
 
lühikokkuvõte: Paediatric medicines development is embedded in the European policy, legislation and in the work of the pharmaceutical industry but currently the potential of this effort is not realised. The conect4children (c4c) project will address the critical problems with the design, implementation and operational conduct of paediatric clinical trials, for example the fragmented and redundant efforts between sponsors, sites and countries. This project will generate a sustainable infrastructure that optimises the delivery of clinical trials in children through: a) a single point of contact for all sponsors, sites and investigators; b) efficient implementation of trials adopting consistent approaches, aligned quality standards and coordination of sites at national and international level; c) collaboration with specialist networks; d) high quality input to study design and preparation through rigorous strategic and operational feasibility assessment and e) the promotion of innovative methodologies. The project will be managed according to IMI2 best practice with a dedicated communications effort. The clinical trials infrastructure will be setup, implemented and tested by implementing 3-4 industry and at least 1 non-industry proof-of-viability studies. Expert advice groups will promote innovative methodologies and engagement with regulators. The business model for a sustainable infrastructure will be based on the European landscape of paediatric networks and available trial sites, the evaluation of services needs of sponsors of all kinds, and will be informed by the proof-of-viability studies. Supporting activities will include: data management (data about the trials and the network, including performance metrics for network management and promotion; handling trial data for non-industry sponsors; support for common data dictionaries); education and training. The voices of children, young people and their families will be central to the network.
partneri jrk nr ja roll partneri nimi riik kontaktisik koduleht
1 koordinaator FONDAZIONE PENTA - FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV ANDRELATED DISEASES - ONLUS IT Carlo GIAQUINTO www.penta-id.org
2 partner THE UNIVERSITY OF LIVERPOOL UK www.liverpool.ac.uk
3 partner OSPEDALE PEDIATRICO BAMBINO GESU IT www.ospedalebambinogesu.it
4 partner EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION FR www.eurordis.org
5 partner EUROPEAN CYSTIC FIBROSIS SOCIETY DK www.ecfs.eu
6 partner STICHTING KATHOLIEKE UNIVERSITEIT NL www.ru.nl
7 partner SWISS CLINICAL TRIAL ORGANISATION CH www.scto.ch
8 partner Associação para Investigação e Desenvolvimento da Faculdade de Medicina PT
9 partner ISTITUTO GIANNINA GASLINI IT http://www.gaslini.org
10 partner UNIVERSITY COLLEGE LONDON UK http://www.ucl.ac.uk
11 partner SIOP EUROPE ASBL BE www.siope.eu
12 partner Tartu Ülikool EE http://www.ut.ee
13 partner OKIDS GMBH AT www.okids-net.at
14 partner UNIVERSITY OF NEWCASTLE UPON TYNE UK www.newcastle.ac.uk
15 partner UNIVERSITEIT GENT BE http://www.ugent.be
16 partner UNIVERSITATSKLINIKUM HEIDELBERG DE
17 partner ARISTOTELIO PANEPISTIMIO THESSALONIKIS EL www.auth.gr
18 partner INSTYTUT POMNIK CENTRUM ZDROWIA DZIECKA PL www.czd.pl
19 partner HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL NO http://www.helse-bergen.no/
20 partner ECNP RESEARCH AND SCHOLARSHIP STICHTING (DE ECNP RESEARCH AND SCHOLARSHIP FOUNDATION) NL www.ecnp.eu
21 partner ROBERT BOSCH GESELLSCHAFT FUR MEDIZINISCHE FORSCHUNG MBH DE
22 partner UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK IE www.ucc.ie
23 partner KAROLINSKA INSTITUTET SE www.ki.se
24 partner FUNDACIO SANT JOAN DE DEU ES www.fsjd.org
25 partner SERVIZO GALEGO DE SAUDE ES www.sergas.es
26 partner GYERMEKGYOGYASZATI KLINIKAI VIZSGALOI HALOZAT HU www.mcrn.hu
27 partner FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS IT www.benzifoundation.org
28 partner ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR www.ecrin.org
29 partner HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ FI www.hus.fi
30 partner INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE FR www.inserm.fr
31 partner HELIOS DR. HORST SCHMIDT KLINIKEN WIESBADEN GMBH DE
32 partner ARSENAL.IT - CENTRO VENETO RICERCAE INNOVAZIONE PER LA SANITA DIGITALE IT www.consorzioarsenal.it
33 partner UNIVERZITA KARLOVA CZ www.cuni.cz
34 partner JANSSEN PHARMACEUTICA NV BE http://www.janssen.com/
35 partner BAYER AKTIENGESELLSCHAFT DE bayer.de
36 partner SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT FR sanofi-aventis.com
37 partner Eli Lilly and Company Limited UK
38 partner UCB BIOPHARMA SPRL BE www.ucb.com
39 partner NOVARTIS PHARMA AG CH
40 partner INSTITUT DE RECHERCHES INTERNATIONALES SERVIER FR http://www.servier.fr
41 partner GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. UK www.gsk.com
42 partner PFIZER LIMITED UK www.pfizer.com
43 partner F. HOFFMANN-LA ROCHE AG CH www.roche.com