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European Clinical Research Infrastructures Network - Integrating Activity

Periodic Report Summary 2 - ECRIN-IA (European Clinical Research Infrastructures Network - Integrating Activity)

Project Context and Objectives:
Clinical trials are critical instruments to promote evidence-based medical practice, fostering innovation, optimising the use of healthcare strategies and containing costs. It however requires international collaboration to rapidly access large patient populations and relevant medical expertise, and to share the cost of trials. Currently only a small amount of independent trials are multinational, pointing to the need for appropriate funding mechanisms and for infrastructural support to the management of multinational trials.
ECRIN (European Clinical Research Infrastructure Network) is the ESFRI-roadmap infrastructure supporting multinational clinical trials in Europe. After completion of its preparatory phase (2008-2011), ECRIN applied to an ERIC status to become a sustainable infrastructure supported by its Member and Observer countries. Simultaneously, the ECRIN-IA project (European Clinical Research Infrastructure Network – Integrating Activity) project was designed to strengthen the capacity to conduct multinational clinical trials in Europe, through the development of specific tools, through the structuring of users communities, through a capacity building policy at the national level, and through the conduct of a few pilot trials testing the overall organisation.
i) Substantial progress was made in the development of tools and procedures supporting multinational clinical trials, including the regulatory data base capturing the complexity of regulatory and ethical requirements for clinical trials on medicinal products, on medical device and on nutrition (WP3), the toolkit of risk-based monitoring strategies (WP8), and the development of the EORTC VISTA data management tool that will be made available as a SaaS to the ECRIN partners (WP9).

ii) Structuring user’s communities at the pan-European scale is a major task for ECRIN, who provides generic support to the management of multinational trials, whereas disease-oriented investigator communities provide the scientific content (clinical trial protocols) and the investigation capacity. The ECRIN-IA focused on three priorities: rare diseases (WP4), medical device (WP5) and nutrition (WP6). Each of these three communities performed a mapping of research capacity, have established a pan-European network of affiliated centres connected to a single hub, and have developed specific tools (methodological support and outcome measures, regulation, standardisation of investigation, etc).

iii) In the meantime, a call for transnational access (WP7) was launched to fund the multinational extension of trials on rare diseases, medical device or nutrition, already funded in the coordinating country. Forty-seven letters of intent were received, 14 were selected for the full application, 8 trials were accepted and eventually only 5 are now conducted with the operational support of ECRIN-IA WP7.

iv) The ECRIN-ERIC legal structure was created in November 2013, during the second reporting period of ECRIN-IA, with five founding countries (DE, ES, FR, IT, PT), followed by three additional countries (CZ, HU, TUR), as a result of ECRIN-IA WP2 on capacity building and extension. ECRIN-ERIC now covers 360 million citizens as potential patients, reaching the critical mass at the global level. This ongoing effort is now expected to result in the adhesion of new countries in 2015.

These considerable achievements will be consolidated over the last year of the project (2015), and the final organisation, procedures and tools will be presented during a final meeting (distinct from the rather ‘internal’ annual meeting, WP3) by end of 2015, open to all the users’ communities, as a signal of maturity of the ECRIN-ERIC who will implement, maintain, upgrade and make these tools developed by ECRIN-IA sustainable.

Project Results:
The Project Summary pdf document contains the core of the report.

Potential Impact:
Clinical research supports evidence-based decision in clinical practice, addressing the question of what is the best treatment option for a disease condition / group of patients. Depending on the disease and on the products available, this may correspond to the development of innovative health products, to the exploration of new indications for already marketed products, or to the comparative assessment of efficacy and safety of existing healthcare (or nutrition) strategies.

As a consequence, clinical research has a major societal impact as it represents a key instrument for treatment optimisation and healthcare cost containment, for the benefit of health authorities, of healthcare professionals, and of course for the benefit of patients.

However, due to the cost and complexity of clinical research, and to the need to access patients and relevant expertise, an efficient organisation of clinical research requires international cooperation. The long-term objective of ECRIN-IA is to contribute to the structuring, at the pan-European level, of a clinical research capacity strengthening the scientific competitiveness and attractiveness for clinical trials. For this purpose, ECRIN-IA addresses four aspects:

- Structuring pan-European investigator communities in rare diseases, medical device, and nutrition (WP4-5-6), is a critical element for the design of relevant clinical trials: clinical questions have to be discussed across a broad expert community before designing a trial, taking into account systematic review of current evidence and uncertainty. In addition, the ECRIN-IA methodology task force provides additional expertise to optimise trial design. Finally, the role of the ECRIN Scientific Board is to improve the methodological standards and the clinical relevance of the supported trials (WP7). This is also the reason why ECRIN-IA includes in its scientific board patients representatives for the selection of the supported projects.

- Conducting these trials requires appropriate infrastructure, both at the national and international level, to ensure efficient patient recruitment, data quality and credibility of the results. In this perspective, ECRIN-IA contributes to the development or upgrade of national infrastructure through its capacity building programme (WP2), and of the pan-European integration of these infrastructures through the structuring of pan-European investigation networks in rare diseases, medical devices and nutrition (WP4-5-6), through the development of education programmes, regulatory databases and e-services (WP3), through the development of common tools for data management (WP9) and monitoring (WP8), and through the experience derived from the conduct of WP7-funded trials.

- Funding for multinational investigator-driven trials is a major bottleneck for academic research. ECRIN-IA makes an attempt to close this funding gap in a model where trials already funded in the coordinating countries receive additional funding through the ‘transnational access’ scheme (WP7) for implementation in other countries. However other funding mechanisms have to be discussed, based on H2020 cooperation projects, but also based on national funding: availability for foreign investigation sites, mutual recognition in the selection of projects... This will be discussed during the WP2 funding workshop, and in the context of the ERIC with the Ministries of the relevant countries.

- Finally interoperability is a key element to enable international collaboration and to boost the scientific competitiveness of Europe in clinical research. Fostering interoperability includes the development of common monitoring (WP8) and data management (WP9) tools for international trials, made available to the EU scientific community, the common regulatory database and e-service tool, the shared training syllabus for clinical investigators (WP3), the lobbying for a better harmonised regulation at the EU and the global levels. Moreover, the pan-European rare diseases, medical device and nutrition (WP4-5-6) networks will share common sets of outcome measures and various specific tools and methodologies for clinical trials. Finally the WP2 capacity building programme allows newly connected countries to adopt the already developed tools and to take into account, for the development of their own national infrastructure, the best adapted models in the other countries, thus fostering interoperability.

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