F-CRIN

The clinical research infrastructure "F-CRIN" (French Clinical Research Infrastructure Network) has been selected through the 2010/11 "Biology and Health Infrastructure" call for proposals by the National Agency of Research (ANR). This call has been launched within the framework of the "Future Investments" of "Large Loaning", loaning launched by French State in 2010 on financial markets.
F-CRIN is also the French partner of European clinical research infrastructure ECRIN/European Clinical Research Infrastructure Network , bringing support to the realization of multinational clinical trials, and coordinated by Pr Jacques Demotes.
F-CRIN project aims to reinforce visibility and competitiveness of France in academic, industrial, as well as European and international clinical research. The objective is to identify and reinforce a few priority themes of France with high potential in translational research, for early clinical trials, also called "proof of concept" trials, especially linked with the pharmaceutical industry, and in parallel, to increase the number of international academic protocols with French scientific coordination. F-CRIN will also have the mission to help, with ECRIN support, the academic sponsors and investigators from other European countries that would like to extend their clinical research projects to French centers.
Eighteen million euros, with additional funding from other partners, have been attributed by the ANR to this project. Its management has been entrusted to INSERM (National Institute for Health and Medical Research).
The national infrastructure F-CRIN, located in Toulouse, is coordinated by Pr Olivier Rascol, neuropharmacologist, with the support of Dr Claire Levy-Marchal, INSERM Coordinator of Clinical Research Department, and Pr Norbert Ifrah, President of National Committee for research coordination of University Hospitals (CNCR) . On a functional point of view, F-CRIN, directed by Vincent Diebolt, previously Director of GIP CeNGEPS, is a mixt service unit (US015), between INSERM, University Hospital of Toulouse, and Toulouse III Paul Sabatier University.
Setting up context
The setting up of F-CRIN project happens in a context in which there is an internationalization of clinical trials issues, and in which it becomes more and more important to catch the opportunities, in particular those initiated by European institutions, while developing the forces and decreasing the weaknesses of France in this domain.
In this context, 3 elements characterize the French clinical research :
* A threatened position with a decreasing number of new clinical trials declared each year to AFSSAPS/ANSM (French medicines agency) : a 2010 LEEM (French association of Pharmaceutical Industry) survey reports that 40% of international trials with Europe participation have been proposed to France on 2008-2010 period and 28% were really realized in France, whereas in 2006, 70% of these trials were proposed to France and 49% were effectively organized in the country
* A recognition of French competency in translational research and for early stage studies. While the global number of investigational drug clinical trials declared each year to AFSSAPS has decreased by 20% between 2006 and 2009 in France, the number of Phase II studies has increased by 16,4% on the same period
*The importance of supporting the participation of France to calls launched at the initiative of European Framework Programme for Research and Technological Development (FPRTD): 7th Framework Programme FP7 (2007-2013) , then Horizon 2020 (2014-2020) .
F-CRIN Governance
F-CRIN governance is monitored by a 6 members Council :
* CNCR (National Committee for research coordination of University Hospitals)
* INSERM (National Institute for Health and Medical Research)
* CPU (Conference of University Presidents) ]
* ARIIS (Health Industries Alliance for Research and Innovation)
* ECRIN (European Clinical Research Infrastructure Network)
* Patient Association Representative
* F-CRIN Coordinator
F-CRIN deployment
The development of the infrastructure will occur in 3 successive steps:
* The first two years (2012/2013) will be dedicated to the constitution and setting up of the structure, as well as a substantive work distributed between 6 work packages (Evaluation ; Unique Counter/Services Coordination ; Common tools development ; Training & Communication ; Clinical Research Networks ; Services Platforms) with roadmaps and precise objectives. Human resources (project managers) whose positions will be funded by F-CRIN will be made available for the coordinator of each of these work packages.
*From 2013 : launch of the first calls for proposals aiming to reinforce the French excellence positions in clinical research by the selection of structures (networks, services platforms) that will have been assessed as the most performing and the most promising with the help of an international jury, ensuring the setting up of a structure offering polyvalent competencies : methodological, scientific and medical, regulatory ...
* F-CRIN is in a perspective of progressive financial empowerment: from the 4th year of its existence, the platform will invoice its provision of services corresponding to its participation to conception, preparation and realization of research projects/protocols.
To date, a first initiative has been engaged by F-CRIN with the organization of a specific training in September 2012:"Achieving the implementation and the conduct of European multinational clinical research projects". This training is intented to the French investigators and sponsors already engaged or wishing to engage in a European approach.

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