The launch of EU-RESPONSE, a 5-year, €15,7M multinational project, funded by the European Unions’ Horizon 2020 research and innovation program for the design and implementation of a new European adaptive platform trial on COVID-19 is yet another demonstration of the central role that the European Clinical Research Infrastructure Network (ECRIN) is playing throughout the COVID-19 crisis.
By the end of March of this year, hundreds of clinical trials were underway at the national level across Europe to test potential treatments SARS-CoV-2, however, there was a marked absence of multinational clinical trials, except for the WHO’s Solidarity trial. ECRIN warned the Commission and promoted the idea of developing multinational, multi-arm platform trial to rapidly recruit patients and to test multiple treatment options.
This led to the EU-RESPONSE project, funded by the European Union and coordinated by INSERM, where ECRIN will play a role in the three key objectives. The first goal is the expansion of DisCoVeRy, a phase III, adaptive randomised, controlled multicentre clinical trial designed to evaluate the efficacy of repurposing medication in hospitalised adult patients diagnosed with COVID-19 to other European countries (Austria, Belgium, Czech Republic, France, Greece, Hungary, Italy, Luxemburg, Norway, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey). Upon completion of the DisCoVeRy trial, a new multinational adaptive European COVID-19 and emerging infectious diseases platform trial network will be built and implemented. The final objective includes the coordination module with the EU-funded RECOVER project, and in particular with the REMAP-COVID trial, to ensure complementarity and cooperation across all the large European COVID-19 Adaptive Platform trials and their capacity to answer the needs of society through dialogue with the EMA, national competent authorities, HTAs and Industry partners. This coordination module is led by ECRIN, and also includes a toolbox to design and manage adaptive platform trials.
EU-Response joins the other tools available at ECRIN to help clinical researchers and national infrastructures in the battle against COVID-19. In April ECRIN launched a Clinical Research MetaData Repository to enable quick access to COVID-19 clinical research and data objects. The ECRIN COVID-19 taskforce continues to update the clinical trials literature reviews, the COVID-19 funding calls and the database on regulatory, ethical and data protection fast track approvals across Europe. Further outreach is underway through the participation in the EU COVID-19 data hub operated by EMBL/EBI with the development of a GDPR-compliant COVID clinical trial patient-level data-sharing platform.
Joining forces in Europe and with international partners will contribute to the global clinical trial capacity for urgently meeting the expectations of society and medicine developers to fight the COVID-19 pandemic. It will also support multinational cooperation in Europe and will have a major impact on epidemic control.
Please find the link to the joint press release by ECRIN, Inserm & the European Commission here.