The first academic multinational clinical trial approval using CTIS

Published on 09/05/2022
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The EU-SolidAct trial, previously authorized under the EU CT Directive 2001/20/EC, has been successfully transferred and is authorized under the new EU regulation (Regulation (EU) No 536/2014) in 12 countries. EU-SolidACT is a European platform trial with a master protocol developed for evaluating treatments in hospitalized patients with COVID-19. The Sponsor team, Oslo University Hospital, with the support of ECRIN and its CTU Networks at the national level have worked intensely over the last months to make this a reality. The trial is currently authorised, for its first treatment arm (Baricitinib) in Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Portugal, Spain, Norway, and Slovakia, with a couple more countries to join pending approval.

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