Kick-off meeting ECRIN - Brussels

On 19 January 2012 we were given the possibility to participate in the kick-off meeting of the ECRIN Integrating Activity which took place in Brussels. The meeting was focused on opening of the ECRIN Integrating Activity of the project and on link with other running activities in individual ECRIP WP. The kick-off meeting of the ECRIN Integrating Activity was running in presence of 33 participants from 23 countries.

The ECRIN (European Clinical Research Infrastructures Network) consortium can be characterized as the European infrastructure granting coordination and service support to academic clinical studies within the framework of coordinating countries of the European Union. ECRIN considers coordination and service support to the workplaces realizing clinical studies its main objective, incl. parallel attraction of participation of the patients in clinical studies in participating countries of the European Union and support by both the investigators and sponsor within the framework of multinational clinical studies. Bridging the gaps and differences of health and legislative systems of individual EU countries is also of great importance. International cooperation is the key factor of success mainly for the sponsors-beginners, for sponsors of clinical studies in university campus as well for clinical research in the field of rare diseases.
The ECRIN consortium has been established with the objective to interconnect the coordination centres in national networks and clinical research units able to grant assistance and support for realization of international clinical studies.

The ECRIN Integrating Activity (2012-16) is the fourth project of the ECRIN programme, following after ECRIN-RKP (2004-5, FP6), ECRIN-TWG (2006-8, FP6) and ECRIN-PPI (2008-11, FP7 ). ECRIN-IA is focused on creation and support to the network structure and extension of the ECRIN partner cooperation through the following five core tasks:

– extension of network and subsequent support and strengthening of national partners
– support to international contacts between individual national partners
– creation of the common European culture between specialists and patient organizations
– development of data management and monitoring for multinational clinical studies
– granting funds for the multinational clinical research projects.

During the meeting in Brussels we were given the possibility to listen inter alia to the report of Jean-Emanuel Faure (the Euro-commissioner) who has summarized the preceding ECRIN projects and set the main targets for the ECRIN-IA project: extension of ECRIN into further 9 countries, creation of credibility
– structure of networks and centres for rare diseases, medical devices and support to nutrition, follow-up assistance to opening of multinational clinical studies in these sectors
– improvement of offered services in the field of data management and monitoring
– development of education and communication with a special focus on new scientific and patient organizations.

The following presentations of individual main coordinators of ECRIP WP (working parties) were running:

– WP1 – management
– WP2 – network extension, creation
– WP3 – education and communication
– WP4 – rare diseases
– WP5 – medical devices
– WP6 – nutrition
– WP7 – multinational clinical studies
– WP8 – monitoring
– WP9- data management

Presentations of individual 9 new countries, interested in creating national centres for clinical studies in their countries and in becoming the full member of the international ECRIN network, were the integral part of the meeting, an important point of meeting for us.

On behalf of the Czech Republic M.D. Demlová presented the intention to create infrastructure for methodological support and for realization of academic clinical studies – the CZECRIN project.
The CZECRIN project is submitted jointly by Masaryk University (MU) and by the St. Ann’s University Hospital in Brno – the International Centre of Clinical Research (FNUSA - ICRC). Both workplaces create one national coordination unit of the CZECRIN project that will coordinate cooperation with other engaged workplaces in the Czech Republic. Masaryk University - through the Institute of Pharmacology of the Faculty of Medicine – will become the primary contact place of the CZECRIN infrastructure for foreign countries.

Masaryk University represents the national coordination and methodological element for fulfilment of specialized tasks and goals of the CZECRIN project, namely through its individual faculties and other Masaryk University workplaces. In the environment of the Czech Republic Masaryk University will coordinate cooperation with the engaged universities within the scope of the so called CZECRIN “University Module”. The CZECRIN University Module will be created by the step-by-step constructed network of the so called „Clinical Trials Centres“ established in individual Czech universities engaged in the project.

FNUSA-ICRC, together with Masaryk University, will ensure project coordination at the national level. Within the Czech Republic FNUSA-ICRC will be responsible for coordination of cooperation with the engaged health centres and this network of workplaces will create the so called CZECRIN “Clinical Module”. When solving specific activities of the projects of clinical trials and clinical studies, the workplaces creating the CZECRIN Clinical Module will ensure services, depending on available capacities and expertises of individual workplaces, in particular the activities connected with incorporation, participation and collection of the data from the subjects of the study.

M.D. Regina Demlová, Ph.D
Bc. Marianna Brabencová