ECRIN-PPI

European clinical research infrastructures network for clinical trials and biotherapy - preparatory phase for the infrastructure

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 Obiettivo del progetto (Objective)

'European clinical research needs an integrated and distributed infrastructure able to provide efficient support to multinational clinical trials, taking advantage of the European population and competencies, unlocking latent expertise and patients scattered across the EU member states. ECRIN (European Clinical Research Infrastructures Network) is designed to bridge the fragmentation of clinical research in Europe through the connection of national networks of clinical research centres and clinical trial units. Participants are currently Austria, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, Switzerland, the United Kingdom, and the EORTC. It will provide integrated, ‘one-stop shop’ services to investigators and sponsors in multinational studies (patient recruitment and investigation, data management, GMP manufacturing of biotherapy products, quality assurance, monitoring, ethics, regulatory affairs and adverse event reporting). With this objective, the preparation phase will consist of - WP2: selection of a legal status and of the governance structure - WP3: agreement on a financial plan leading to a long-term sustainability during the construction step and the operation phase - WP4: survey on needs in terms of GMP facilities for biopharmaceuticals and biotherapy, and their design. - WP5: education programme for multinational clinical studies - WP6: extension to other EU member states - WP7: capacity building to help national networks fulfil the sponsor’s tasks - WP8: update and upgrade of the quality assurance system - WP9: internal and external communication - WP10: accreditation of data centres - WP11: support to pilot projects Users will be investigators and sponsors in the academic and SME sector. Participants will be the national coordination of clinical research infrastructures, and national ministries and funding agencies in order to reach an agreement ensuring the long-term sustainability of the infrastructure.'

Introduzione (Teaser)

The creation of a single European area for clinical research can have a hugely beneficial impact on Europe's health and economy. It will help scientists working in critical areas, such as cancer and rare diseases, to find partners and funding opportunities.

Descrizione progetto (Article)

Clinical research involves testing, not only new medicines, but also therapies, devices and surgical procedures. In order to effectively evaluate such research, multinational cooperation is needed to optimise treatment strategies and help contain healthcare costs.

Creating a single European area for clinical research will therefore strengthen the EU's competitiveness in clinical science. It will help to unlock latent scientific potential and expertise, facilitating multinational studies initiated by investigators from any European country. This has been the goal of the EU-funded ECRIN-PPI project: to encourage and facilitate greater international cooperation in clinical trials.

This ambitious project, which began in 2004, has succeeded in establishing an infrastructure to support investigators and sponsors in multinational clinical studies. It has also sought to develop common standards and tools so as to reduce research fragmentation across Europe.

Involvement in the project has given researchers the capacity to initiate and participate in multinational clinical studies, and has increased access to EU funding. ECRIN-PPI is expected to have a major impact on health and the economy, fostering the development of innovative health products, promoting the independent evaluation of healthcare strategies and contributing to cost containment.

The project has also supported the structuring of disease-oriented investigation networks, linked to a pan-European hub. Expanding this strategy could lead to clinical and biomedical research support structures in Europe. ECRIN-PPI now plans to support the structuring of networks in three strategic areas: rare diseases, medical devices and nutrition.

Based on its findings, the project has made several legislative recommendations. These are now being discussed at the global level in the Organisation for Economic Co-operation and Development (OECD) working group to facilitate international cooperation in non-commercial clinical trials.