In addition to its portfolio of multinational clinical trials, ECRIN contributes to various capacity building projects. Diverse in scope and country involvement, these projects have a shared goal of improving the landscape for clinical research in both Europe and internationally. In some cases, capacity building projects may include clinical trials (e.g., ECRIN Integrating Activity, see below).
Capacity Building Projects
The Horizon 2020-funded CORBEL project aims to establish shared services between the European Strategy Forum on Research Infrastructures Biological and Medical Sciences Research Infrastructures (ESFRI BMS RIs)–which includes ECRIN–for the biomedical research community. CORBEL will achieve this by creating cross-infrastructure scientific workflows. A suite of common services will be developed and dynamically updated in response to specific user and research infrastructure needs. Partnerships with user communities working in European programmes such as Joint Programming Initiatives (JPI) or ERA-NETs (European Research Area Networks) and private-public partnerships such as the Innovative Medicine Initiative (IMI) will be facilitated by single access points and joint services.
The illustration below shows how ECRIN interacts specifically in CORBEL with other biomedical RIs, highlighting RI focus areas and disease priorities.
Medical Infrastructure / Users Forum (MIUF)
ECRIN is leading the work package in charge of the creation of a medical infrastructure / users forum (MIUF), which is a body of scientific experts. The MIUF aims to be a key instrument for the efficient development and use of biomedical research in Europe. It will guide the development of shared services and support their incorporation within participating research infrastructures and partner institutions, laying a solid foundation for long-term cooperation.
As part of the MIUF's work, a questionnaire was created to collect the needs and expectations of medical research communities and overall users of RIs. The responses have been collected and analysed in a report. They will be used as input to gather recommendations for continuous improvement and development of new, transversal services.
CORBEL has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 654248.
The Clinical Research Initiative for Global Health (CRIGH) aims to support international collaboration on clinical research for the benefit of patients, healthcare professionals, and health systems. The initiative will seek to optimise clinical research programmes in participating countries, to develop global standards on clinical research, to promote the take-up of innovative methodology and technologies, and to enhance institutional capacity to rapidly and efficiently respond to global health challenges.
Launched in 2016, CRIGH is a follow-up to the Organisation for Economic Co-operation and Development (OECD) Global Science Forum (GSF) initiative, introduced in 2009 to foster international cooperation in non-commercial trials. The GSF made various recommendations to address three main challenges to multi-country collaboration: persisting differences in administrative processes; inadequate regulation for some clinical trials; and uneven national and regional support for education, training and infrastructures for academic clinical trials.
CRIGH is the first global initiative to address the wide range of obstacles to global cooperation in clinical research, facilitating both multi-country commercial and non-commercial trials.
CRIGH includes six projects:
- Infrastructure and funding: developing a network of high-quality and interoperable clinical trial units (CTUs), and promoting additional funding for independent, international trials.
- Global core competencies: promoting harmonized education, training and careers for investigators and clinical research professionals.
- Research ethics: promoting quality, consistency and training among research ethics committees.
- Patient involvement: fostering the involvement of patients as trial participants and in trial design.
- Comparative effectiveness research and socio-economic impact: promoting methodologies for efficient comparison of treatment strategies, and assessing the medical, social and economic impact of evidence.
- Regulatory awareness: developing databases on ethical and regulatory requirements, and recommendations to facilitate international cooperation.
CRIGH will primarily focus on investigator-initiated trials and trials involving small and medium enterprises (SMEs).
The CRIGH consortium is composed of Members and Observers - research institutions or organisations, or consortia of research institutions. ECRIN shares the secretariat with the National Institutes of Health (NIH).
ECRIN Integrating Activity (ECRIN-IA) is a collaborative project, initially running from 2012 to the end of 2015, funded by the European Commission Framework Program 7 and involving 23 countries (click here for country contacts). Work package (WP) 7 was extended until 2017.
ECRIN-IA’s purpose is to build a consistent organisation for clinical research in Europe, providing generic tools and services to multinational studies, and supporting the construction of pan-European disease-oriented networks that will become ECRIN users and provide clinical research projects. This organisation will improve Europe’s attractiveness to industry, boost its scientific competitiveness, and result in better healthcare for European citizens. Activities are divided into nine work packages (WPs):
- WP1–Management, governance and coordination of the project
Overall management of the project is coordinated by the ECRIN Paris office.
- WP2–Expansion, capacity building and funding
Networking activities promote pan-European expansion, capacity building and partnership with other world regions, and promote appropriate funding mechanisms.
- WP3–Education, e-services and communication
E-services for researchers and education material to train professionals and patients associations are developed in this work package, which also addresses communication with users, patients, citizens and policymakers.
- WP4, 5 & 6–structuring rare disease, medical device and nutrition networks
Structuring European hubs and networks for clinical research on rare diseases (WP4), medical devices (WP5) and nutrition (WP6). The networks will design and conduct multinational clinical studies.
- WP7–Transnational access
Transnational access activities support the cost of multinational extension of clinical trials selected by the ECRIN Scientific Board. Five trials are supported in three areas: MENAC (nutrition); ESCALE and POEM vs LHM (medical devices), RESCUE ESES and IMPACTT (rare diseases).
Identification, assessment and validation of tools for the implementation of risk-based monitoring strategies will improve the efficiency of ECRIN services.
- WP9–Data management
Adaptation of the VISTA Trials data management software will provide a state-of-the-art and efficient Clinical Data Management Tool for multinational clinical trials to the ECRIN user community and for non-commercial clinical research.
This project has received funding from the European Union’s Seventh Framework Programme for Capacities - Research Infrastructures under grant agreement no. 284395.
The EOSCpilot project will support the first phase in the development of the European Open Science Cloud (EOSC) as described in the EC Communication on European Cloud Initiatives . In particular, it will:
- Establish the governance framework for the EOSC and contribute to the development of European open science policy and best practice;
- Develop a number of pilots that integrate services and infrastructures to demonstrate interoperability in various scientific domains;
- Engage with a broad range of stakeholders, crossing borders and communities, to build the trust and skills required for adoption of an open approach to scientific research.
The EOSCpilot project will address some of the key reasons why European research is not yet fully tapping into the potential of data. In particular, it will:
- Reduce fragmentation between data infrastructures by working across scientific and economic domains, countries and governance models;
- Improve interoperability between data infrastructures by demonstrating how data and resources can be shared.
In this way, the EOSC pilot project will improve the ability to reuse data resources and provide an important step towards building a dependable open-data research environment where data from publicly funded research is always open and there are clear incentives and rewards for the sharing of data and resources.
ECRIN is involved in the work package on policy, and in particular is the lead, along with BBMRI, on the sub-task on drivers and constraints for ethics. This subtask will investigate ethical issues related to the use/re-use of data and services and will produce practical recommendations on each of them.
The EOSCpilot has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 739563.
The EuroStemCell project, funded by the European Commission’s Horizon 2020 funding programme, aims to help European citizens understand stem cells. Over 400 stem cell labs participate in the project, and contributors include scientists, clinicians, ethicists, social scientists and science communicators. To communicate stem cell research, EuroStemCell has created a website and multilingual content such as non-technical fact sheets on key questions and concepts, and a toolkit of films, comics, lesson plans and games to facilitate education and outreach.
ECRIN is a partner in EuroStemCell, and is currently involved in EuroStemCell’s work on resources for decision-making and interfacing with the press and broadcast media.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no 652796.
MiRoR is an innovative and ambitious joint doctoral training programme funded by Marie Skłodowska-Curie Actions, dedicated to Methods in Research on Research in the field of clinical research. ECRIN is involved in the project as a consortium member.
“Research on Research” is an emerging new scientific discipline that aims to reduce waste in research and increase research value. Tens of billions of Euros are wasted each year on studies that are redundant, flawed in their design, never published or poorly reported. The public is the main victim of this waste and reducing waste and increasing value of research represents a major societal challenge.
MiRoR will train 15 PhD students to become the future generation of high-level scientists to develop innovative methods of Research on Research. The students will be awarded with a double degree.
This project is funded by the European Union’s Horizon 2020 Marie Sklodowska Curie Innovative Training Networks- European Joint doctorate (ITN-EJD) under grant agreement number 676207.
Funded by Horizon 2020, the Paediatric Clinical Research Infrastructure Network (PedCRIN) brings together ECRIN and the European Paediatric Clinical Trial Research Infrastructure (EPCTRI) to develop capacity for multinational paediatric clinical trials.
Launched on January 1st, 2017, the project will last four years and includes five work packages (WPs):
- WP1: Project coordination and implementation of management decisions
- WP2: Definition of the PedCRIN business strategy and governance structure
- WP3: Development of tools specific for paediatric and neonatal trials (trial methodology and outcome measures, adverse event reporting bio-sample management, ethical and regulatory database, monitoring, quality and certification)
- WP4: Provision of operational support to select pilot trials, which will be coordinated by ECRIN with the support of national paediatric coordinators hosted by paediatric networks (that currently exist or are being set-up)
- WP5: Communication targeting user communities (including industry partners) and policymakers, and aiming to empower patients and parents
To learn more about PedCRIN and the need for multinational paediatric clinical studies, see the fact sheet
This project has received funding from the European Union’s Horizon 2020 programme under grant agreement number 731046.
This H2020 project aimed to: create a European-wide network of procurers; define a common innovation procurement roadmap in the short and long term; and define the public procurement of innovation procedure(s) that best meet needs and support the early detection and screening of functional low vision conditions, or would support the provision for low vision services.
ECRIN was involved in work packages on information management, online engagement/dissemination, and resources for decision-making and the media.
PRO4VIP received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 645584.
RISCAPE will provide a comprehensive, peer-reviewed international landscape analysis report on the position and complementarities of the major European research infrastructures (RIs). To achieve this, RISCAPE will establish close links with a stakeholder panel representing the main user groups of the report and will collaborate closely with RI projects and initiatives. The report is intended to inform the EU strategic RI development and policy. This project is in line with the European Commission’s strategy on EU international cooperation in research and innovation.
ECRIN is leading work on biomedical sciences and will draft the landscape analysis report in the biomedical sector.
RISCAPE has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 730974.
RItrain aims to develop a flagship training programme enabling research infrastructures (RIs) across all domains to gain expertise on governance, organisation, financial and staff management, funding, intellectual property (IP), service provision and outreach in an international context. ECRIN is involved in work packages on project management; definition of competencies required by RIs; and continuing professional development for managers of RIs.
RItrain is organising three pilot staff exchanges as part of its mission to share management expertise among European Research Infrastructures. Learn more here
RItrain has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 654156.
TRANSVAC2 is the follow-up project to its successful predecessor project TRANSVAC, the European Network of Vaccine Research and Development funded funded by European Union Framework Programme 7, FP7.
The TRANSVAC2 consortium includes leading European institutions that propose to further advance with the previous initiative towards the establishment of a fully operational and sustainable European vaccine R&D infrastructure.
TRANSVAC2 will support innovation for both prophylactic and therapeutic vaccine development based on a disease-overarching and one-health approach, thereby optimising the knowledge and expertise gained during the development of both human and animal vaccines. This will be achieved by bridging the translational gap in biomedical research, and by supporting cooperation between public vaccine R&D institutions of excellence, related initiatives and networks in Europe, and industrial partners.
TRANSVAC2 will contribute to the development of effective products to address European and global health challenges, to controlling the burden and spread of infectious diseases, and to the reinforcement of the economic assets represented by vaccine developers in Europe.
ECRIN is leading the work package on clinical trial support. In this role, ECRIN will provide information/advice on the development of multinational vaccine clinical trials; provide consulting on appropriate design/methodology for such trials; and support regulatory and ethical submissions in trial participating countries. ECRIN is also involved in the work package on regulatory support.
TRANSVAC2 has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 730964.