Periodic Reporting for period 3 - EU-RESPONSE (European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases)
Reporting period: 2023-07-01 to 2024-12-31
The DisCoVeRy trial, a phase 3, multi-arm adaptive trial, was first launched in France in 2020 with the aim of expanding to other European countries and strengthening trial management capacity. The primary objective was to evaluate both repurposed and novel medicines rapidly while adapting to new waves of the epidemic in Europe. More broadly, the goal was to establish a sustainable clinical trial network across Europe, specializing in emerging infectious diseases (EID).
In parallel, a multinational European adaptive platform trial was developed with strong governance to provide a modular trial framework for COVID-19 and other emerging infectious diseases. EU-SolidAct enables hospitals across Europe to participate at their preferred level of commitment. The initiative also aimed to expand the network of trial sites across European and associated countries and to successfully launch at least one trial to demonstrate the feasibility of the approach.
Finally, a coordination mechanism was put in place to align European COVID-19 adaptive platform trials, creating links between RECOVER, EU-RESPONSE, VACCELERATE, and ECRAID-Prime. This mechanism, initially named OCToPUs (Organisation for COVID-19 Trial Platforms in Europe), also fostered dialogue with external stakeholders to define high-level specifications for COVID-19 research in the EU while optimizing the use of adaptive platform trials. Additionally, a toolbox was developed to facilitate and harmonize the design and management of these trials across Europe.
In parallel, a multinational European adaptive platform trial was developed with strong governance to provide a modular trial framework for COVID-19 and other emerging infectious diseases. EU-SolidAct enables hospitals across Europe to participate at their preferred level of commitment. The initiative also aimed to expand the network of trial sites across European and associated countries and to successfully launch at least one trial to demonstrate the feasibility of the approach.
Finally, a coordination mechanism was put in place to align European COVID-19 adaptive platform trials, creating links between RECOVER, EU-RESPONSE, VACCELERATE, and ECRAID-Prime. This mechanism, initially named OCToPUs (Organisation for COVID-19 Trial Platforms in Europe), also fostered dialogue with external stakeholders to define high-level specifications for COVID-19 research in the EU while optimizing the use of adaptive platform trials. Additionally, a toolbox was developed to facilitate and harmonize the design and management of these trials across Europe.
The DisCoVeRy trial expanded to 63 sites across 13 European countries and assessed the efficacy and safety of several interventions, including remdesivir and AZD7442 (tixagevimab/cilgavimab). No significant impact was observed on clinical status at day 15, hospital length of stay, or mortality for these drugs. However, the trial laid the groundwork for a proactive European network dedicated to emerging infectious diseases.
Within EU-SolidAct, a master protocol for COVID-19 was approved, and the trial network grew to include more than 14 countries. Two multinational trials were launched, a governance system was implemented, and diverse stakeholders were engaged. Advanced statistical methodologies were developed and applied to ensure data integrity. A framework for individual patient data meta-analysis (IPDMA) was established, leading to two completed IPDMAs. Additionally, an infrastructure for sample collection and biological analysis was set up, and key findings have been published.
The coordination mechanism has prevailed as a forum for exchange, and a key facilitator for collaboration. The dialogue has expanded beyond Covid-19, and successfully integrated new networks and stakeholders following the dynamic of the research preparedness landscape. JAAM has evolved to JAAM 3.0 expanding its scope to vaccines and all infectious diseases with epidemic or pandemic potential, started a horizon scanning activity with proactive reaching out to developers while holding the regular meetings.
Within EU-SolidAct, a master protocol for COVID-19 was approved, and the trial network grew to include more than 14 countries. Two multinational trials were launched, a governance system was implemented, and diverse stakeholders were engaged. Advanced statistical methodologies were developed and applied to ensure data integrity. A framework for individual patient data meta-analysis (IPDMA) was established, leading to two completed IPDMAs. Additionally, an infrastructure for sample collection and biological analysis was set up, and key findings have been published.
The coordination mechanism has prevailed as a forum for exchange, and a key facilitator for collaboration. The dialogue has expanded beyond Covid-19, and successfully integrated new networks and stakeholders following the dynamic of the research preparedness landscape. JAAM has evolved to JAAM 3.0 expanding its scope to vaccines and all infectious diseases with epidemic or pandemic potential, started a horizon scanning activity with proactive reaching out to developers while holding the regular meetings.
Beyond its primary objective of testing therapeutic interventions, the project has led to the establishment of a biocollection that supports ancillary studies on host responses to infection and treatment. It has also reinforced collaboration among clinical partners within the consortium and the virological network VirVolt.
The establishment of an adaptive platform trial during a pandemic represents a major step toward creating a recognized, sustainable European network for clinical research on emerging infectious diseases in hospitalized patients.
The coordination model is currently integrated in the EU funded CSA CoMeCT, where it builds a stronger knowledge base, and transfer with cohort researchers, facilitates for data harmonization and provides inclusive overviews of ongoing research. This work is promoting resource sparing and will be integrated in the upcoming European Pandemic Preparedness Partnership. JAAM is integrated in CoMeCT as well.
The establishment of an adaptive platform trial during a pandemic represents a major step toward creating a recognized, sustainable European network for clinical research on emerging infectious diseases in hospitalized patients.
The coordination model is currently integrated in the EU funded CSA CoMeCT, where it builds a stronger knowledge base, and transfer with cohort researchers, facilitates for data harmonization and provides inclusive overviews of ongoing research. This work is promoting resource sparing and will be integrated in the upcoming European Pandemic Preparedness Partnership. JAAM is integrated in CoMeCT as well.