Strengthening Europe’s Preparedness for Future Pandemics
Creating an Adaptive Clinical Trial Network
Context
Recent health crises (especially COVID 19) have highlighted the urgent need for faster and more coordinated responses to pandemics. Building on lessons learned, this initiative aims to reinforce Europe’s ability to respond to future health emergencies by establishing an adaptive clinical trial network. This network will improve how clinical research is conducted in real time during outbreaks
Objectives
- Accelerate Response: Enable rapid setup and implementation of clinical trials for treatments and vaccines during health emergencies.
- Enhance Collaboration: Bring together healthcare professionals, researchers, policymakers, and civil society to work in closer coordination.
- Strengthen Infrastructure: Build a robust framework that links clinical trials with laboratory networks and legal systems across Europe.
- Develop Tools: Create flexible tools and systems to support effective, cross-border collaboration and decision-making during emerging health threats.
This initiative is structured around key workstreams, including:
- Adaptive clinical trial design and execution
- Laboratory coordination and data sharing
- Legal and regulatory alignment to support rapid trial deployment
By strengthening existing networks and improving collaboration across Europe, this effort will ensure that future pandemic responses are not only faster, but more effective and inclusive.
By involving civil society in this project and publishing the progress of our work, we are remaining true to the spirit of Open Science.
We are providing the public, scientists and healthcare professionals with direct access to clear, trusted, and accurate scientific information. We are thus preventing disinformation and scams that exploit crises and have become particularly prevalent since the COVID-19 pandemic.
Workstreams
The project is divided into seven workstreams addressing areas such as clinical trials, laboratory networks, and legal frameworks.
Workstream 1
Project coordination and impact
Workstream 1 oversees the coordination of the project ensuring efficient administrative, financial, and technical management. Progress is tracked via biannual reports. Upcoming tasks include establishing the SEAB, creating a management handbook, and developing an exploitation plan.
Main objectives:
- Coordinate the EU-PROACT project.
- Manage administrative, financial, and technical operations to meet EU requirements.
- Monitor progress through internal reports every six months, tracking deliverables and milestones.
- Establish the SEAB (Stakeholder and Expert Advisory Board) to guide the project.
- Develop key project tools, including a management handbook, an exploitation plan, and regular Executive Committee meetings.
Workstream 2
Management of the adaptative plateform trial and preparedness tools
Workstream 2 manages adaptive platform trials and develops tools for multi-country trial preparedness. It sets up governance structures, handles regulatory documents, and oversees trial activities like safety monitoring and transitions between trial phases.
Main objectives:
- Manage adaptive platform trials and develop tools for multi-country trial preparedness.
- Establish governance structures like the Trial Steering Committee, Data Safety Monitoring Board, and Trial Management Team.
- Develop regulatory and ethical submission documents essential for trial approval.
- Oversee ongoing trial activities, including safety monitoring, reporting, and transitioning from EU-SYNDACT-1 to EU-SYNDACT-2.
- Create tools to address sponsor-specific challenges in logistics, ethics, and management, enabling rapid trial scaling during pandemics.
Workstream 3
Clinical trial network and investigation
This workstream expands a network of clinical trial sites across Europe for respiratory virus therapies and pandemic response. It includes site identification, training, and preparedness. Trials are conducted under master protocols for current and emerging pathogens.
Main objectives:
- Expand a network of clinical trial sites across Europe for respiratory viral infection research.
- Identify and evaluate new trial sites to support rapid trial deployment.
- Build site capacity through training and preparedness programs (WP11).
- Develop and implement master trial protocols for both current and emerging pathogens.
- Conduct EU-SYNDACT-1 and EU-SYNDACT-2 trials as part of the network’s testing activities.
Workstream 4
Methodological capacity and statistical analysis
This workstream provides statistical and methodological support for EU-PROACT trials. It focuses on trial design, real-time data sharing, and integrating observational studies. Standardized outcome sets are developed to ensure data consistency.
Main objectives:
- Provide robust statistical and methodological support for platform trials conducted within the EU-PROACT framework.
- Design statistical protocols, manage data, and perform analyses for the EU-SYNDACT trials, to ensure optimal trial execution.
- Develop real-time data sharing methods, to enable rapid evidence generation and support faster, informed decision-making across trials.
- Integrate observational and cohort studies using target trial emulations, to strengthen understanding of antiviral treatment effectiveness.
- Develop core outcome sets, to standardize effectiveness measures across trials, enhancing data comparability and supporting systematic reviews, in collaboration with networks and public stakeholders.
Workstream 5
Network of virology laboratories and biomarkers
Workstream 5 focuses on specialized biological analyses and biomarker development to measure treatment efficacy.
Main objectives:
- Develop and validate biomarkers for assessing treatment efficacy, including virological, immunological, and genetic markers.
- Conduct standardized viral load and biological testing using the VIRvOLT European virology lab network during and after clinical trials.
- Develop advanced diagnostic tools, such as quantitative PCR and multiplex assays for respiratory pathogens.
- Expand and sustain a coordinated virology laboratory network to support clinical research.
- Perform and streamline specialized biological testing before and during, ensuring efficient biomarker discovery and routine diagnostics.
Workstream 6
Social and implementation science
Workstream 6 is dedicated to applying social and implementation science to refine trial design, enhance recruitment, and strengthen engagement, with a focus on marginalized and under-represented populations.
Main objectives:
- Integrate social and implementation science to improve trial design, recruitment, and engagement, especially for marginalized groups.
- Conduct qualitative research including evidence synthesis, media discourse analysis, and real-time studies during trials.
- Identify barriers and facilitators to trial participation and develop recommendations for more inclusive trial practices.
- Foster cross-site and interdisciplinary partnerships to embed social science at the core of the project.
- Deliver interviews, focus groups, and process evaluations as part of the EU-SYNDACT-1 trial assessment.
Workstream 7
Capacity Building, community involvment and communication
Workstream 7 focuses on building capacity, improving communication, and promoting community engagement to support trial readiness and ensure effective sharing of trial outcomes.
Main objectives:
- Prepare trial sites and build capacity by delivering tailored training to ensure readiness for conducting clinical trials.
- Improve communication strategies to address and combat disinformation, while fostering trust among local communities.
- Establish community advisory boards and promote meaningful patient involvement in shaping trial design and communication.
- Empower patients and community members to take active roles in both the trial process and in sharing its outcomes.
- Disseminate trial results broadly to key stakeholders—including patients, healthcare providers, and policymakers—for greater public awareness and impact.
