European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases (EU-RESPONSE)

In the context of COVID-19, there is an urgent need to move rapidly into large randomised clinical trials that could determine the efficacy of new or repurposed medicines as rapidly as possible and with the ability of recruiting patients wherever there is significant transmission and disease. This proposal is precisely aimed at addressing this need building on the ongoing experience of DisCoVeRy and importantly going beyond to define platform trials for next generation antivirals and for testing immunomodulatory and/or Acute respiratory distress syndrome agents. The proposal is state of the art in that it is bringing 21 major players together, who will learn from each other, which is expected to lead to a more integrated approach towards treatments for the COVID19 and emerging infectious diseases. The applicants plan to use adaptive trials, and these become more common (e.g. in oncology) and can have the advantage to change arms if treatments appear to demonstrate problems with safety or toxicity.
CZECRIN, as a third link party of ECRIN will participate in WP3 where the dialogue with all the relevant stakeholders in the package will be established to define a European strategy on COVID-19 Adaptive Platform Trial Network, to define its specification, to ensure cooperation and complementarity with other platforms such as REMAP-CAP/REMAP COVID Adaptive Platform Trial, and to streamline the main amendments to the master protocol and the introduction of new arms. Work package (WP3) will create a bridge between the two initiatives, ensuring complementarity, harmonization and synergies. WP3 will also deliver a comprehensive development strategy for COVID platforms in Europe, provide a streamlined access for interventions requesting a new arm, and offer – where required – technical and methodological support for the establishment and the management of platform trials.

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