Toggle Main Menu Toggle Search

Open Access padlockePrints

The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children

Lookup NU author(s): Becca Leary, Dr Francesca Rocchi

Downloads


Licence

This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2021, The Author(s).The need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials. Across Europe, the difficulties with clinical research are compounded by variation within countries and between countries. Ethics and regulatory review have national specificities. This paper describes the Collaborative Network for European Clinical Trials for Children (conect4children, c4c), which addresses selected difficulties in the design and conduct of paediatric clinical trials. c4c is a time-limited public–private consortium funded by the Innovative Medicines Initiative (IMI2). The elements of c4c are as follows: expert advice providing input on study design and/or paediatric development programmes (including patient involvement activities); a network of sites following harmonised procedures coordinated by National Hubs and a single point of contact for Europe; a facility for education and training for sites and trial teams; and support for managing data used by the network and a common paediatric data dictionary. c4c does not sponsor trials. c4c is taking a phased approach with careful piloting through industry and non-industry studies intended to demonstrate the viability of the network (proof-of-viability studies). c4c uses a co-design approach involving industry and academics within a clearly defined scope. A sustainable, successor organization open to all potential service users will be open for business before the end of IMI2 funding in 2024.


Publication metadata

Author(s): Turner MA, Hildebrand H, Fernandes RM, de Wildt SN, Mahler F, Hankard R, Leary R, Bonifazi F, Nobels P, Cheng K, Attar S, Rossi P, Rocchi F, Claverol J, Nafria B, Giaquinto C

Publication type: Article

Publication status: Published

Journal: Pharmaceutical Medicine

Year: 2021

Volume: 35

Pages: 71-79

Print publication date: 01/03/2021

Online publication date: 04/02/2021

Acceptance date: 15/12/2020

Date deposited: 01/04/2021

ISSN (print): 1178-2595

ISSN (electronic): 1179-1993

Publisher: Springer International Publishing AG

URL: https://doi.org/10.1007/s40290-020-00373-6

DOI: 10.1007/s40290-020-00373-6


Altmetrics

Altmetrics provided by Altmetric


Actions

Find at Newcastle University icon    Link to this publication


Share