Community Research and Development Information Service - CORDIS

Periodic Report Summary 3 - 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.
The objectives of the ECRIN-IA project were to:
- expand the network and strengthen the national partners and partnership with other world regions
- develop pan-European investigation networks in three strategic areas (rare diseases, medical devices, nutrition)
- develop a common and de-fragmented culture and common tools for multinational projects.

Project Results:
This period resulted in major achievements for the development of ECRIN and for the structuring of its users communities. Although an extension of the ECRIN-IA project was needed to complete the five multinational clinical trials supported in the context of the ‘Transnational access’ work package (WP7), all the other activities within ECRIN-IA were completed by December 31st 2015, after a presentation and discussion during a meeting in Paris on December 7-8th 2015.

This includes the ECRIN regulatory and ethical database (the ECRIN Campus) providing awareness on regulatory and ethical requirements for clinical trial authorization in 23 European countries. This freely accessible and searchable database covers not only the clinical trials on medicinal products (whose regulatory framework is partly harmonised by the 2001/20/EC Directive), but also the clinical trials on medical device or on nutrition, subject to highly divergent national regulation. A training tool was derived from this database to promote awareness of national regulatory and ethical requirements. Regular updates of this database are planned, including a major upgrade when all the national legislations / regulation implementing the Clinical Trial Regulation 2014/536 will be released.

Ensuring clinical trial data quality at an affordable cost is a major challenge for ECRIN and its partners, and two initiatives were designed to tackle this issue. First ECRIN-IA supported the development of a risk-based monitoring toolbox, proposing a spectrum of risk-based, cost-effective monitoring strategies ensuring patient protection, data quality and robustness of results without unnecessary burden and costs, in line with the OECD Council Recommendation on the Governance of Clinical Trials. Depending on the nature of the trial, sponsors and principal investigators may select one of these options (available on www.ecrin.org) to develop their monitoring plan for multinational trials. A second initiative supporting data quality is the upgrade of the EORTC clinical trial management system VISTA, to make it available for the clinical trial units members of the national ECRIN partner networks. This will provide an affordable and highly professional solution to improve the quality of data management in European academic institutions, and will also promote a data standard that may facilitate the subsequent use for meta-analyses based on individual patient-level data. The software was presented at the December 2015 meeting in Paris, validation is ongoing, and it will be made available as Software as a Service (SaaS) to ECRIN data centres in the next few months.
Robustness and credibility of results requires methodological support and recommendations, especially in the field of rare diseases (addressing the issue of small sample size), or for clinical trials on medical device or nutrition where designing a randomised trial raises complex issues related to blinding, comparator, controls etc. A methodology taskforce was therefore in charge of inventorying these methodological challenges to make recommendations that are currently published in a series of methodological articles. Another methodological aspect covered by ECRIN-IA is the use of patient-relevant and standardized outcome measures for clinical trials. ECRIN-IA supported the development of a database of outcome measures for clinical trials on medical devices (also accessible on www.ecrin.org), while promoting the development of standardized outcome measures in rare diseases in partnership with initiatives such as IRDiRC (International Rare Diseases Research Consortium), and COMET (Core Outcome Measure for Effectiveness Trials) – this collaboration with COMET is ongoing in the context of the H2020 CORBEL cluster project.
Strengthening users communities in the field of rare diseases, medical device and nutrition, as well as strengthening their partnership with ECRIN, was a major objective of the ECRIN-IA project. This was achieved through the call for support to multinational trials (that was restricted to clinical trials on rare diseases, medical device and nutrition), and through the development of the above-mentioned tools, including the regulatory and ethical data base and the methodological recommendations. In addition, a mapping of investigation centres and clinical trial units specialising in clinical trials on rare diseases, medical device and nutrition was performed, through surveys and meetings, with the double objective to identify and inventory these expert centres and their areas of competence, and also to make them aware of the tools and operational services proposed by ECRIN.

Communication with the patients and citizens, and with the scientific community was considerably facilitated by the maturity of the tools developed by ECRIN, and by the upgrade of the website into a professional communication tool. Whereas the December 7-8th 2015 ECRIN meeting in Paris was an opportunity to present all the achievements of the ECRIN-IA project and the spectrum of services provided by ECRIN-ERIC, the International Clinical Trial Day was organised in May 2015 in Trondheim, with a focus on transparency in clinical trials. This is since 2009 a critical issue for ECRIN, as our eligibility criteria include the commitment to provide access to anonymised patient-level clinical trial data after completion of the trial. This is now also a requirement of the International Committee of Medical Journal Editors (ICMJE), and ECRIN is working, in the context of the CORBEL WP3.3, to define a standard data sharing plan and procedure.
The capacity building and mobility programme resulted in a thorough description of the national organizations supporting clinical research, in exchange of best practice, and in the application of new countries as ECRIN-ERIC Member and Observer. Among others, Switzerland joined as an Observer in 2015, whereas negotiations were ongoing with Norway (who joined as a Member in 2016), with Ireland, Turkey, Luxembourg and others. The issue of funding multinational trials was also addressed through a workshop co-organised with ISCIII in Madrid, leading to the conclusion that an ERA-net mechanism (virtual common pot) would be an excellent solution to unlock the national funding and to amplify the capacity of Europe to conduct multinational trials. This resulted in proposals, borne by Spain, for an ERA-net on clinical research.

Potential Impact:
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.
The tools developed over the ECRIN-IA project and now available on the www.ecrin.org website represent major assets for ECRIN and will substantially facilitate the conduct of multinational clinical trial in Europe, thus reducing the fragmentation and promoting integration of clinical research in the European Research Area.
As developed in ECRIN-IA, the model of interaction between a generic infrastructure, providing services to the management of trials in any disease area, and investigation networks focusing on the scientific content and on patient recruitment and investigation, was the basis of the joint application with the paediatric community (PedCRIN) to the 2016 INFRADEV3 call, that was successfully evaluated, to develop a paediatric module within ECRIN. This model was also generalized in the CORBEL cluster project where the Medical Infrastructures / Users Forum (MIUF) was established (CORBEL WP3.1) to bring together medical research infrastructures (ECRIN, EATRIS, BBMRI, INFRAFRONTIER, ELIXIR, EuroBioImaging etc) and medical research communities (neuroscience, mental health, cancer, cardiovascular, nutrition, rare diseases, paediatrics, infectious diseases, vaccines etc) to capture their needs in terms of infrastructures, to drive the development of adapted services, and to define a joint strategy avoiding gaps, fragmentation and duplication.
Substantial progress was made in the establishment of international collaboration, either through bilateral agreements (with collaboration agreements signed in 2015 with Korea and with the US NIH / NCATS, while similar agreements were prepared with Brazil and Japan), or through multilateral collaboration. ECRIN hosted in 2015 a preparatory meeting for the OECD implementation initiative, that resulted in the drafting of the Clinical Research Initiative for Global Health (CRIGH), in which ECRIN is expected to play a prominent role.

List of Websites:
www.ecrin.org

Reported by

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
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