Conect4children

CONECT4CHILDREN

COllaborative Network for European Clinical Trials For Children

Financed by: European Comission

Programme: IMI2: CALL 10-INNOVATIVE MEDICINES INITIATIVE 2017

Grant Agreement ID:  777389

Rol in the project: Partner

Duration: May 2018 to April 2024

ABSTRACT

“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.”

PARTNERS

  • FONDAZIONE PENTA – FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV ANDRELATED DISEASES – ONLUS (Coordinator)
  • THE UNIVERSITY OF LIVERPOOL
  • OSPEDALE PEDIATRICO BAMBINO GESU
  • EURORDIS – EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION
  • EUROPEAN CYSTIC FIBROSIS SOCIETY
  • STICHTING KATHOLIEKE UNIVERSITEIT
  • SWISS CLINICAL TRIAL ORGANISATION
  • Associação para Investigação e Desenvolvimento da Faculdade de Medicina
  • ISTITUTO GIANNINA GASLINI
  • UNIVERSITY COLLEGE LONDON
  • SIOP EUROPE ASBL
  • TARTU ULIKOOL
  • OKIDS GMBH
  • UNIVERSITY OF
  • NEWCASTLE UPON TYNE
  • UNIVERSITEIT GENT
  • UNIVERSITATSKLINIKUM HEIDELBER
  • ARISTOTELIO PANEPISTIMIO THESSALONIKIS
  • INSTYTUT POMNIK CENTRUM ZDROWIA DZIECKA
  • HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL
  • ECNP RESEARCH AND SCHOLARSHIP STICHTING
  • ROBERT BOSCH GESELLSCHAFT FUR MEDIZINISCHE FORSCHUNG MBH
  • UNIVERSITY COLLEGE CORK – NATIONAL UNIVERSITY OF IRELAND, CORK
  • KAROLINSKA INSTITUTET
  • FUNDACIO SANT JOAN DE DEU,
  • SERVIZO GALEGO DE SAUDE,
  • GYERMEKGYOGYASZATI KLINIKAI VIZSGALOI HALOZAT,
  • FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS,
  • ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK,
  • HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ,
  • INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE,
  • HELIOS DR. HORST SCHMIDT KLINIKEN WIESBADEN GMBH (participation ended),
  • ARSENAL.IT – CENTRO VENETO RICERCAE INNOVAZIONE PER LA SANITA DIGITALE,
  • UNIVERZITA KARLOVA,
  • JANSSEN PHARMACEUTICA NV,
  • BAYER AKTIENGESELLSCHAFT,
  • SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT,
  • Eli Lilly and Company Limited,
  • UCB BIOPHARMA SRL,
  • NOVARTIS PHARMA AG,
  • INSTITUT DE RECHERCHES INTERNATIONALES SERVIER IRIS,
  • GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.,
  • PFIZER LIMITED, 43. F. HOFFMANN-LA ROCHE AG,
  • AZIENDA SANITARIA UNIVERSITARIA FRIULI CENTRALE,
  • UNIVERSITA DEGLI STUDI DI CAGLIARI,
  • SERVICIO MADRILENO DE SALUD,
  • RETE ITALIANA PER LE SPERIMENTAZIONI CLINICHE IN PEDIATRIA

 

 

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