Periodic Reporting for period 1 - EU-RESPONSE (European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases)
Reporting period: 2020-07-01 to 2021-12-31
Secondly, based on the experience acquired from DisCoVeRy, EU-RESPONSE aim was to build a multinational, European multi-arm COVID-19 Adaptive Platform Trial. The platform needs to have a strong governance to provide a modular trial framework for COVID-19 and other emerging infectious diseases enabling most, if not all, European hospitals to participate at their preferred level of commitment, to develop the network of sites within European and associated countries and to launch at least a trial.
The project also aims to collaborate with other COVID-19 and emerging infectious disease initiatives in Europe and beyond, through a shared workpackage with the EU-funded project RECOVER.
Discussions with stakeholders has led to the development and the submission through the VHP procedure of the Master protocol for the EU-SolidAct Adaptive Platform Trial. The teams of the various roles, such as sponsor, data management and analysis, were selected. A first IMP specific trial was submitted to competent authorities across 14 states and was launched in spring 2021, 225 patients have been randomised so far.
A Trial Coordination Board (TCB) that brings together key stakeholders of the COVID-19 adaptive platform trials has been established, as well as the Joint Access Advisory Mechanism (JAAM) that assesses candidate compounds that could become new trial arms.
The expected impact for EU-SolidAct Adaptive Platform Trial is to become a recognized sustainable European network in the field of clinical studies of emerging infectious diseases in hospitalized individuals.
The TCB has become a trusted platform for the exchange of scientific information and insights for public policy; facilitating networking and collaboration. The JAAM provides independent scientific advice for optimal selection of new study arms. They will continue to support COVID-19 research, and will set the precedent for future research programs.