Project title: Curriculum Development of Human Clinical Trials for the Next Generation Biomedical Students
Registration number: 2018-1-HU01-KA203-047811
Duration of the project: 31/12/2018 – 31/08/2021
Total budget: EUR 299 755
Coordinator:University of Pecs
Partners: Université Paris Diderot – France
Universidade Nova de Lisboa - Portugal
Clinical Research Development Ireland (CRDI) – Ireland
Masaryk University - Czech
In CONSCIOUS project the planned European and world-wide level of e-learning material and curriculum will meet the needs of biomedical students towards having a very unique and socially useful career via an innovative online, work-based, multi-disciplinary learning model. The cooperation between project partners and the associated partners gives a solution to a real-world problems (development of innovative health products, exploration of new indications for authorised health products, comparative assessment of efficacy and safety of approved healthcare strategies) via increasing the efficiency of international clinical trials.
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. 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:
1. Infrastructure and funding: developing a network of high-quality and interoperable clinical trial units (CTUs), and promoting additional funding for independent, international trials.
2. Global core competencies: promoting harmonized education, training and careers for investigators and clinical research professionals.
3. Research ethics: promoting quality, consistency and training among research ethics committees.
4. Patient involvement: fostering the involvement of patients as trial participants and in trial design.
5. 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.
6. 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.
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.
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.
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
This project has received funding from the European Union’s Horizon 2020 programme under grant agreement number 731046.