Table 1 Descriptions of the three studies included in this paper
From: Experiences and challenges with the new European Clinical Trials Regulation
Study | Description |
|---|---|
EU-SolidAct / Bari-SolidAct (EU CTR : 2022-500385-99-00) | • EU-SolidAct denotes the platform trial and is part of the EU-RESPONSE project (EU Horizon 2020 Grant no. 101015736) • Bari-SolidAct is a phase 3 sub-investigation looking into the efficacy and safety of the JAK-inhibitor baricitinib in hospitalised COVID-19 patients ◦ Submitted and approved under the CTD (CTD 2001/20/EC) through VHP in 14 European countries in the spring of 2021 [2, 3] ◦ 14 initial countries: Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Portugal, Slovakia, and Spain ◦ Fully academic (Sponsor, Oslo University Hospital) ◦ Platform and trial arm were transferred from VHP governed by CTD to CTIS governed by CTR 15th March 2022 |
AXL-SolidAct (EU CTR: 2022-500363-12-00) | • Phase 2b trial assessing the efficacy of the AXL-inhibitor bemcentinib on hospitalised patients with moderate pulmonary COVID-19 • New arm in the EU-SolidAct platform trial • Submitted 19 April 2022 |
MOSAIC (EU CTR: 2022-501132-42-00) | • Observational cohort study of clinical and virological outcomes in human mpox virus disease (formerly monkeypox) • Sponsor: University of Oxford; Sponsor’s representative in Europe: French National Agency for Research on AIDS (ANRS)/Inserm; Sponsor’s representative in Switzerland: Geneva University Hospital • Launched in response to a request from the EMA Clinical Trials Coordination Group (CTCG) for an observational study to characterise the evolving outbreak across Europe • Collects only clinical data and research samples • Study aims to describe the clinical and virological outcomes of patients with laboratory confirmed mpox • Inside the EU: Classified as a Low Intervention Clinical Trial as data is collected on mpox patients who receive tecovirimat (a drug newly authorised under “exceptional circumstances” without being studies in an mpox population) • Outside the EU (UK and Switzerland, and France prior to the CTIS application): received approval as an observational trial • Study initially submitted in June 2022 in eight EU/EEA countries: Belgium, France, Ireland, Italy, Netherlands, Norway, Portugal, and Spain |