2.O.10 EUROPEAN CLINICAL RESEARCH INFRASTRUCTURES NETWORK (ECRIN) AS A SUPPORT TO MULTINATIONAL TRIALS

Abstract

Clinical research needs distributed infrastructures: efficient patient recruitment is a major bottleneck to clinical research, whereas quality of investigation, credibility of data, and compliance with regulation require professionalized support. The European Clinical Research Infrastructures Network (ECRIN) is designed to support multinational clinical research in the European Union. It is based on the connection of national hubs, each coordinating a national network of generic clinical research centres or of disease-oriented networks. Supported by the European Commission (FP7 Infrastructure programme) as an ESFRI roadmap infrastructure, it promotes multinational collaboration within the European Union, taking advantage of the EU population size and unlocking latent scientific potential.

Building such a distributed, pan-European infrastructure requires addressing the challenge raised by the fragmentation of health and legislative systems. Networking of national clinical research infrastructures led to the development of common standards, of harmonised tools and practice. In addition, ECRIN provides integrated, ‘one-stop shop’ services to investigators and sponsors in multinational studies: patient recruitment and investigation, quality assurance, monitoring, ethical and regulatory requirements, adverse event reporting, circulation of medicinal products and of blood and tissue samples, data management. Information and consulting also help investigators prepare their study: ethical and regulatory requirement, insurance, centre selection, cost evaluation, funding opportunities. Access is given to users (mostly investigators and sponsors in the academic institutions that often lack the capacity to act as a sponsor in the conduct of EU-wide studies) after assessment of the protocol by the scientific board. Services provided by ECRIN are particularly relevant for research on rare diseases and neglected diseases, for clinical trials in elderly and paediatric populations, for academic clinical research institutions, and for clinical trials steered by biotechnology SMEs.