Created in 2004, ECRIN set out to become an organisation that could facilitate multinational clinical trials in Europe. It began by implementing various European-level projects to lay the groundwork for its future development.
ECRIN’s first project (2004-05) focused on strategy, the second (2006-08) on tools, and the third (2008-12) on infrastructure development. By 2013, ECRIN had become what it set out to be: a unique, sustainably-funded, non-profit organisation, based on country membership, supporting mostly academic sponsors and investigators across Europe to overcome the barriers to multinational clinical research.
Read on to find out more about ECRIN’s history!
First project to identify bottlenecks to multinational collaboration and define strategy: 2004 to 2005
From 2004 to 2005, ECRIN led its first project, ECRIN Reciprocal Knowledge Programme or ECRIN-RKP (funded by European Union Framework Programme 6, FP6, "Societal challenges” health sub-programme), involving six countries.
ECRIN-RKP aimed to determine bottlenecks to multinational collaboration in academic clinical studies. These were identified as discrepancies in the national organisation and practice of clinical research, as well as the inability of academic institutions to fulfil sponsors’ responsibilities in foreign countries (e.g., due to a lack of national partners or understanding of national legal and regulatory requirements, among others).
The ECRIN-RKP pilot project led to the definition of a strategy for the creation of a pan-European infrastructure for clinical research, which would become the basis for ECRIN’s future structure. The idea was to create an institutional body to facilitate multinational clinical trials by linking national scientific partners (networks of clinical trial units, CTUs) across Europe and by providing management and other services to investigators and sponsors.
Second project to develop tools and ESFRI roadmap: 2006 to 2008
Starting in 2006, ECRIN began its second project, ECRIN Transnational Working Group or ECRIN-TWG (also funded by FP6), involving 10 countries, to develop procedures and guidelines for investigators and sponsors involved in multinational clinical research in Europe.
The project involved analysis of existing data management tools, training resources, and national regulatory and ethical requirements, leading to recommendations and guidance documents. As part of the project, ECRIN began to develop common monitoring tools to enhance collaboration. It also started to establish networks of academic clinical trial units across Europe.
Another key development during this time was the inclusion of ECRIN, in 2006, on the European Strategy Forum on Research Infrastructures (ESFRI) roadmap (i.e., a European instrument for the optimal use and development of research infrastructures). This gave ECRIN additional legitimacy and visibility, and paved the way towards a sustainable future.
Third project to build a sustainable infrastructure and initial services: 2008 to 2011
ECRIN’s third project, ECRIN Preparatory Phase for Infrastructure or ECRIN PPI (funded by European Union Framework Programme 7, FP7, for which ECRIN was now eligible given its ESFRI status) was launched in 2008 with 14 countries. The goal was to define the necessary organisational and legal structure for ECRIN to support the establishment and implementation of multinational clinical trials in Europe. In short, it aimed to develop ECRIN’s business plan and legal status.
The project validated ECRIN’s proposed organisation, whereby the Paris-based Core Team oversees the work of European Correspondents (EuCos), situated in Member and Observer Countries (i.e., dues paying members); EuCos manage the clinical trial portfolio and support services in their respective countries in coordination with national scientific partners. Learn more.
As part of ECRIN PPI, ECRIN began to provide services to multinational clinical studies in 2009. It also established its Scientific Board and started data centre certification.
Fourth project to build capacity in rare diseases, medical devices and nutrition and ERIC status: 2012 to present
In 2012, ECRIN embarked on its fourth project, ECRIN Integrating Activity or ECRIN-IA (also funded by FP7), involving 23 countries and covering three main areas of expertise: rare diseases, medical devices and nutrition. Objectives included: structuring national scientific partners; developing capacity to manage multinational trials; strengthening user communities; developing databases and toolkits; fostering patient communication; and conducting pilot multinational clinical trials. Originally planned for four years (2012 to 2015), the clinical trials work package was extended until 2017.
In parallel, ECRIN continued to develop its service offer, providing various forms of support to European clinical trials. It established standards for the acceptance of projects applying for such services.
Late 2013, ECRIN was awarded the status of European Research Infrastructure Consortium (ERIC) by the European Commission – a legal status to facilitate the establishment and operation of research bodies of European interest. This was a key development as it ensured ECRIN’s financial sustainability.
Since 2013, ECRIN’s Paris-based Core Team has more than doubled in size, welcoming specific functions to develop its legal, capacity, operations, communications, quality and other support. With nine Member and Observer Countries as of 2016, it plans to increase its membership and to develop additional partnerships with European and international stakeholders.