What is PROACT EU Response?
Envisaged in 2023, the PROACT EU RESPONSE project can be considered as a new step of the EUROPE RESPONSE project (https://eu-response.eu/). The PROACT EU Response project was proposed following a call for proposals from the European Union.
This project has been approved and has received funding from the European Union’s Horizon Europe research and innovation programme, under Grant Agreement No. 101156304.
This project will last five years, from January 2025 to January 2030.
Why PROACT EU Response?
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. Proact EU Response will also preventing disinformation and scams that exploit crises and have become particularly prevalent since the COVID-19 pandemic.
The overarching objective is to consolidate networks, enhance collaboration, and develop tools to enable a rapid and effective response to emerging threats.
Through this collaboration, the initiative will work to decrease mortality and morbidity rates associated with emerging diseases, ultimately improving health outcomes for populations across Europe.
In addition to its direct health benefits, PROACT EU Response seeks to lower the economic and societal costs of disease by strengthening research, innovation, and human expertise in the fight against communicable diseases.
The consortium is led by ANRS Emerging Infectious Diseases and Inserm.
The consortium is composed of 25 partners from 11 countries
The consortium is aided by a strong network of 9 virological centers, 5 methodology teams and 4 implementation science teams located in 23 different countries.
The project is divided into seven workstreams addressing areas such as clinical trials, laboratory networks, and legal frameworks.
The initiative directly responds to the growing call for « a resilient European Union prepared for emerging threats ». It highlights the importance of addressing major societal challenges tied to the European Commission’s political priorities, particularly in terms of strengthening preparedness, response, and surveillance of health threats and epidemics.
Here’s an overview of each workstream and how they interconnect to achieve Proact EU Response project objectives.
Workstreams and specific objectives
Workstream 1: Project coordination and impact.
Lead : ARNS MIE / INSERM TRANSFERT.
Partners involved : Biomerieux SA / ECRIN / Forum des Patients Europeens / Hospices Civils de Lyon / INSERM ARNS MIE / INSERM TRANSFERT / Oslo universitetssykehus HF / Universitat Basel / University College Dublin / University of Galway / University College of London / Université Libre de Bruxelles.
Workstream 1 focuses on project coordination and ensuring a smooth execution of the EU-PROACT initiative by managing collaboration among 25 partners across 11 countries.
This workstream will ensure that administrative, financial, and technical aspects of the project run efficiently to meet all European Union requirements.
The lump-sum funding project will be managed through internal progress reports every six months, by tracking deliverables and milestones.
Activities in the coming months include establishing the SEAB (Stakeholder and Expert Advisory Board), creating a project management handbook, developing a plan for the exploitation of project results, and holding Executive Committee meetings.
Workstream 2: Management of the adaptative plateform trial and preparedness tools.
Lead : ECRIN / ARNS MIE.
Partners involved : APHP / ECRIN / Hospices Civils de Lyon / INSERM ARNS MIE / INSERM TRANSFERT / Oslo universitetssykehus HF / Servicio Madrileño de Salud / University College of London / Université Libre de Bruxelles.
Workstream 2 focuses on managing adaptive platform trials and developing preparedness tools for large multi-country trials.
Key tasks include establishing trial governance structures, such as the Trial Steering Committee, Data Safety Monitoring Board, and Trial Management Team.
Workstream 2 will create essential documents for regulatory and ethical submissions.
It will also address ongoing trial activities such as safety monitoring, reporting, and transitioning from EU-SYNDACT-1 to EU-SYNDACT-2.
Two work packages focus on developing supportive tools, including solutions for sponsor-specific challenges related to logistics, ethics, and trial management, ensuring rapid scalability in pandemic contexts.
Immediate milestones for the next six months include finalising timelines, assigning partner tasks, and initiating trial committee meetings.
Workstream 3: Clinical trial network and investigation.
Lead : University College Dublin / University College of London / Université Libre de Bruxelles.
Partners involved : ECRIN / INSERM ARNS MIE / Oslo universitetssykehus HF / Servicio Madrileño de Salud / University College Dublin / University College of London / Université Libre de Bruxelles.
Workstream 3 focuses on expanding a network of clinical trial sites across Europe to test therapies for respiratory viral infections and to ensure rapid responses during pandemics.
This workstream is built around four work packages: WP10 (Network development), WP11 (Training and preparedness), WP12 (EU-SYNDACT-1 trials), and WP13 (EU-SYNDACT-2 trials).
Key activities include identifying and expanding trial sites, capacity-building through site evaluations and training, and creating master protocols for trials targeting both existing and emerging pathogens.
Workstream 4: Methodological capacity and statistical analysis.
Lead : Oslo universitetssykehus HF / Universitat Basel.
Partners involved : APHP / INSERM ANRS MIE / Oslo universitetssykehus HF / Stichting Nederlandse Wetenschappelijk Onderzoek Instituten / Universitat Basel / University Of Bristol / University College Dublin / University of Galway / Università degli studi di Verona.
This workstream is focused on delivering robust statistical and methodological support for platform trials within the EU-PROACT framework.
This workstream is divided into several work packages:
- Work package 4.1 focuses on statistical design, data management, and analysis for the EU-SYNDACT trials, thereby ensuring optimal protocol and trial execution.
- Work package 4.2 concentrates on developing methods for real-time data sharing across trials and rapid evidence generation to enable faster decision-making.
- Work package 4.3 integrates observational and cohort studies through target trial emulations, improving knowledge of antiviral treatments.
- Work package 4.4 focuses on developing core outcome sets to standardize measures of effectiveness across trials, enhancing data comparability and facilitating systematic reviews and meta-analyses.
The team will collaborate with various networks and stakeholders, including public groups, to define the most appropriate outcomes.
Workstream 5: Network of virology laboratories and biomarkers.
Lead : Biomerieux SA / Hospices Civils de Lyon.
Partners involved : Biomerieux SA / Hospices Civils de Lyon / INSERM ANRS MIE / University College Dublin.
Workstream 5 focuses on customized biological analyses and the development of biomarkers for treatment efficacy.
It leverages the expanded European virology laboratory network, VIRvOLT, to conduct standardized viral load testing and advanced biological analyses during and after clinical trials.
Key tasks include the development of quantitative PCR assays for viral load monitoring, the exploration of multiplex assays for respiratory pathogens, and the research of new biomarkers to better understand treatment efficacy.
The workstream is structured into three work packages:
- WP20 is focused on expanding and sustaining the virology network.
- WP21 aims at developing diagnostic assays before trials.
- WP22 focuses on performing specialized biological tests during trials.
The classification of biological tests into three categories ensures streamlined testing, from routine hospital lab work to centralized biomarker discovery.
Biomarker research focuses on virological, immunological, and genetic markers to guide personalized treatment strategies and to improve understanding of antiviral resistance.
Workstream 6: Social and implementation science.
Lead : University College of London.
Partners involved : Universiteit Antwerpen / University of Galway / University Of Lancaster / University College of London / Università degli studi di Verona.
Workstream 6 focuses on integrating social and implementation science to optimize trial design, recruitment, and engagement, particularly for marginalized and under-represented groups.
Key activities include qualitative evidence synthesis, media discourse analysis, and rapid qualitative research to gather real-time insights during trials.
The team will evaluate barriers and facilitators to trial participation and develop recommendations for inclusive trial design and effective public health communication.
Social science will be at the core of the project through partnerships across sites and disciplines.
Deliverables involve conducting interviews, focus groups, and real-time process evaluations of EU-SYNDACT-1.
Workstream 7: Capacity Building, community involvment and communication.
Lead : Forum des Patients Européens.
Partners involved : CNRS / Collectif No Fakemed / Forum des Patients Europeens / Les Markabiens / NILE Vaccination et Lien Social.
Workstream 7 is dedicated to strengthening capacity, enhancing communication, and fostering community involvement to ensure trial readiness and the effective dissemination of trial results.
The main goals include preparing trial sites through tailored training, combatting disinformation, and fostering trust among communities.
The workstream emphasizes creation of community advisory boards and empowering patients to actively engage in trial design and the dissemination of results.
Dissemination efforts will target multiple audiences, including patients, policymakers, and healthcare providers, to ensure broad awareness and impact of trial outcomes.
In this first article, we wanted to introduce you to the project, its structure, and its main objectives.
We will regularly publish new articles and content to keep you informed of the project’s progress and developments.
We hope you will find this initiative as exciting and impactful as we do. We work together to make a difference in public health and beyond.
We would like to thank the European Union for its willingness to support our initiative to strengthen Europe’s capacity to respond to future health emergencies.
