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ECRIN

Integrating clinical research in Europe: the European Clinical Research Infrastructures Network

Jacques Demotes-Mainard.jpg Roxan Brachet.jpg Christine Kubiak.jpg

Jacques Demotes-Mainard, Roxane Brachet, Christine Kubiak

INSERM, Institut de Santé Publique, PARIS

www.ecrin.org

Summary

ECRIN consists of integrating national clinical research facilities into a EU-wide network, able to provide support to clinical research in any medical field, and for any type of clinical research through information and consulting, and through a set of flexible services for the conduct of multinational clinical studies. This distributed infrastructure, based on the integration of competence centres, provides access to clinical research projects after assessment by its scientific board. A team of European correspondents working in the coordinating centre of each national network is the key actor in the provision of consulting and decentralised services. These services are particularly relevant for academic clinical research, especially under circumstances where international cooperation is required (ie. in rare diseases), or for clinical trials sponsored by biotechnology SMEs who often lack the capacity to act as a sponsor in EU-wide studies.

Introduction

Development of diagnostic and therapeutic innovation, and delivery of improved health care to EU citizens requires clinical research during the whole process extending from understanding the mechanism of disease, genetic studies or identification of biomarkers, clinical development and evaluation, and to post-marketing strategy trials. The recent development of therapeutic innovation is mainly based on biopharmaceuticals and on personalized treatments, on pharmacogenetics and toxicogenetics, on the use of biomarkers, and requires access to large populations of patients, enabling clinical trials adapted to these new therapeutic strategies with a need to focus on specific patient subpopulations (1-5). Further, a very large number of rare diseases are without effective interventions. In addition, the quality of clinical trials and other clinical investigations, the quality of clinical and biological data, and the rate of enrolment of patients into clinical trials are all requiring urgent improvements. Hence, the quality of the clinical research infrastructure is one of the main factors determining the competitiveness of European clinical research. European academic research (6), as well as the pharmaceutical and biotechnology research and development need an efficient, integrated, and professionalized organization of clinical research, based on competence centres able to provide efficient support through a consistent set of services for clinical trials. Infrastructures supporting clinical trials, data management, quality assurance, monitoring, ethics, and regulatory submissions are required for improving the quality and raising the credibility of data. An integrated, EU-wide infrastructure allows the conduct of multinational studies in Europe, taking advantage of the EU population and competencies, unlocking latent expertise and patients currently scattered across the EU member states.

ECRIN: a three-step project

The European Clinical Research Infrastructures Network (ECRIN) is designed to improve the capacity of the European Union to perform high-quality clinical research, and to promote innovative pharmaceutical and biotechnology development as well as development of other interventions (7). This integrated clinical research infrastructure bridges the fragmentation of clinical research in Europe through the interconnection of national networks of clinical research centers and clinical trial units. ECRIN participants are currently Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, Switzerland, and the United Kingdom (Figure 1). ECRIN plans extension to other existing national networks in other member states, and stimulates the set-up of new national networks for further connection through its capacity building programme.

Figure 1: Map of countries participating in ECRIN.

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Coordinated by the National Institute of Health and Medical Research in France (INSERM), ECRIN started with a first project (2004-2005), funded by the European Commission under the FP6 Health programme, and helped identify bottlenecks to multinational collaboration (mostly the poor capacity of academic institutions to act as sponsors in multinational studies) and define a strategy for provision of services (mostly support to sponsors across the borders) (8 -10)

This conclusion served as a basis for the second phase of the ECRIN project (2006-2008, FP6 Health Programme) in which transnational working groups prepared guidelines and procedures to support clinical studies in any medical field, in any patient population, and for any type of study.

These working groups covered: interaction with ethics committees, interaction with competent authorities and regulatory requirements, adverse event reporting, data management, study monitoring, and quality assurance.

In its third step (2008-2011, FP7 Health priority - Infrastructures programme), ECRIN enters into the preparatory phase of the European strategy forum on research infrastructures (ESFRI) roadmap infrastructures. During this current third phase, the team of European Correspondents, a specialised staff located at the coordinating centre of each national network (Figure 2), provides decentralised support to multinational studies through a set of flexible services to investigators and sponsors (interaction with ethics committees, with competent authorities and support on regulatory submissions, in adverse event reporting, in drug dispensing, in the circulation of blood and tissue samples, in study monitoring). ECRIN also provides centralized services, including data management through accredited data centres.

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Figure 2: Organisation of the network

ECRIN may also help with consulting and practical information on ethical and regulatory requirements, insurance, centre selection, cost evaluation, and funding opportunities during the preparation of the clinical research project.

An independent scientific board is in charge of providing access to ECRIN, based on a set of eligibility and acceptance criteria (see www.ecrin.org).

Impact and users

ECRIN has a substantial impact on the structuring of clinical research in the European Union, through the debate on the legislative framework for clinical research in the EU by contributing to the discussion on the 2001/20/EC Directive (12, 13) and to the FP7 ICREL (Impact on Clinical Research of European Legislation) project (14). ECRIN also promotes the active participation of patients and citizens, and transparency in clinical research, and has launched the International Clinical Trials Day (each 20th of May, see www.jameslindlibrary.org) as a yearly communication event on the challenges raised by clinical research. In addition, ECRIN initiated, with the other ESFRI-biomedical research infrastructures and the pharmaceutical companies as participants, the FP7 Innovative Medicines Initiative (IMI) (15, 16) EMTrain project to develop a pan-European education platform (www.emtrain.eu).

Such an integrated infrastructure will benefit mainly the academic scientific community but also SMEs or pharmaceutical companies, and public-private partnership programs, as well as series of projects developed by disease-oriented scientific networks. As access to patients is a limiting factor, ECRIN will promote research on rare diseases, improving diagnostics and treatment strategies. This will enable translation of medical innovation into healthcare, hence to the benefit of patients and citizens.

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References

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6 Remuzzi G, Schieppati A, Boissel JP, Garattini S, Horton R: Independent clinical research in Europe. Lancet 364: 17232-6 (2004).

7 Demotes-Mainard J, Ohmann C : European Clinical Research Infrastructures Network : promoting harmonisation and quality in European clinical research. Lancet 2005; 365, 107-108.

8 Demotes-Mainard J, Chêne G, Libersa C, Pignon JP : Clinical research infrastructures and networks in France : report on the french ECRIN workshop. Thérapie, 60:183-199, 2005.

9 See reports and comparative analyses on www.ecrin.org

10 Demotes-Mainard J, Ohmann C, Gluud C, Chene G, Fabris N, Garattini S, Carné X, Lafolie P, Collet JP, Crawley F. European Clinical Research Infrastructures Network Meeting report : ‘Towards an integration of clinical research infrastructures in Europe’, Brussels, Feb 14-15th, 2005. Int J Pharm Med, 19:43-45, 2005.

11 Krleža-Jeric K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C for the Ottawa Group. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa Statement (part 1)[1]. BMJ 2005;330:956-8.

12 EC-EMEA conference on the Operation of the Clinical Trials Directive, Oct.2007, London.

13 ESF-EMRC Consensus Conference Investigator-Driven Clinical Trials, Sep. 2008, Strasbourg.

14 ICREL conference on Impact on Clinical Research of European Legislation, Dec. 2008, Brussels http://www.efgcp.be/Conference.

15 Donnelly F, Jehenson P. European Technology Platform on Innovative Medicines. Int J Pharm Med, 19 :153-161 (2005).

16 The Innovative Medicines Initiative (IMI) Strategic Research Agenda: Creating Biomedical R&D Leadership for Europe to Benefit Patients and Society, http://www.imi-europe.org/organisation/governance/pages/default.aspx.

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