The PEDSTART network is a network of excellence in pediatric clinical investigation. It brings together the 7 expert Clinical Investigation Centers (CICs), which are coordinated by the University of Tours (CICs of Bordeaux, Lille, Lyon, Nantes, Paris-Necker EM, Paris-R. Debré and Toulouse).
There are 8 other CICs being progressively integrated (CICs of Brest, Clermont-Ferrand, Dijon, Grenoble, Marseille, Montpellier, Rennes and Rouen).
PEDSTART also includes 2 pediatric research networks HUGOPEREN (Pediatric Research Network of University Hospitals of the Greater West) and RIPPS (Pediatric Investigation Network of Health Products).
This network is a continuation of a former network of pediatric CICs.
Gouvernance and functioning
The governance of PEDSTART is ensured by an Executive Committee, supported by a Steering Committee. The coordination team ensures the functioning and the strategic orientations of the projects of the network. It consists of two coordinating pediatricians who are associated with an operational team (project managers, quality manager, administrative assistant).
Any member of the network who initiates a project or who is asked to participate in a project with a European scope is invited to inform the PEDSTART coordination team of the existence of this new project, and to propose it as a priority to the network in the event of a multi-center trial.
Each member of the network is committed to respect the confidentiality of the information exchanged during the various meetings. Confidentiality agreements have been signed by each CIC.
Network members and their partners can submit any type of project, whether industrial or academic and at any stage of development. The PEDSTART network can not itself be a sponsor of a trial, but will be able to provide methodological and logistical support at each stage of the project. Inserm is able to be the sponsor for projects involving PEDSTART.
Key element of an accepted project:
- Innovative design
- Early stages of development including « proof of concept »
- Establishment of cohorts or bio-banks, pharmacology
- International character (European dimension essential to the framework of c4c)
- EMA designated rare diseases and therapies
Each member of the network remains free to accept or decline to participate in the realization of a project, regardless of reason.
- Medical: Applies for premature to adolescent age groups and all pediatric disciplines, including but not limited to the following: neonatology - developmental origins of health status, gastroenterology - nutrition, infectious and inflammatory diseases, pneumology and rare diseases
- Scientific: methodology, pharmacology, modeling and epidemiology adapted to studies in children
- A national network of CIC pediatric experts spread across the country
- Privileged links with additional European experts
PEDSTART participates in the European bodies for research in children (EnprEMA, PedCRIN, EPCT-RI ...). The network is a member (category III) of the Enpr-EMA network of the European Medicines Agency (EMA).
Enpr-EMA brings together research networks, investigators and centers of expertise. Its main objective is to facilitate clinical studies to increase the availability of medicines to treat children. This is done through support for the development of relevant, high quality and European level clinical trials and support for the recruitment of patients in these trials.