Pandemic preparedness and response: Sustaining established coordination mechanisms for European adaptive platform trials and/or for cohort networks

ExpectedOutcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• The research community sustains appropriate coordination mechanisms 1) among different EU-wide adaptive platform trials and/or 2) among established cohorts in Europe and beyond with a view for better pandemic preparedness and response,
• The adaptive platform trial and/or the cohort networks maximise coordination and harmonisation of their respective studies within their relevant network for maximum research efficiency and optimal evidence generation.
• The European adaptive platform trial and/or the cohort networks coordinate with the European Pandemic Preparedness Partnership, and are well connected to each other and to relevant other regional and global initiatives.

Scope:

The COVID-19 pandemic research response has illustrated the importance of clinical research preparedness, as well as the benefit gained from the coordination between European clinical research initiatives. Two key pillars of such clinical research in pandemic preparedness and response are the clinical (interventional) trials and the cohort (observational) studies.

The large-scale European COVID-19 clinical trials have been gathered under a network for COVID-19 therapeutic trials^[1] and a network for COVID-19 vaccine trials^[2] and strong common coordination mechanisms between the trials have been established. The recently launched Ecraid^[3] is a European clinical research network that has been in development since before the COVID-19 pandemic. The EU-funded projects conducting cohort research in Europe and globally have also come together to establish stronger coordination between them.

This topic aims at maintaining and strengthening existing strategic coordination mechanisms across adaptive platform trials and across cohort studies in Europe and beyond for avoiding redundancies, promoting complementarities and facilitating cooperation among EU-funded clinical research for infectious diseases. Proposals should strengthen the leading role of the EU in clinical research preparedness for future epidemics and pandemics, through ensuring coordination of the European adaptive platform trials and of the European cohort studies. The coordination mechanisms support the longer-term perspective of preparedness for future infectious disease epidemics and pandemics, where the networks enable the conduct of perpetual platform trials and of perpetual strategic cohorts with the in-built agility to pivot to emerging diseases when an epidemic strikes.

Proposals should describe a coordination mechanism for adaptive platform trials and/or for cohort research. The coordination mechanism builds on existing coordination efforts for these networks, providing strategic support and vision for the perpetual trials and cohort studies belonging to the networks in the context of pandemic preparedness. Within the adaptive platform trial network, the coordination mechanism supports reflections e.g. on the diversity of the trial target populations (e.g. primary care or hospitalised patients) or on different possible medical countermeasures (e.g. therapeutics, vaccines), etc. Within the cohort network, the coordination mechanism supports reflections e.g. on diversity in type of cohorts and research questions to be addressed, or on harmonised approaches to data collection and analysis, etc.

Proposals should address proper connections with relevant European initiatives and organisations, such as the European Pandemic Preparedness Partnership, the European Health Preparedness and Emergency Response Authority (HERA), as well as the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). Synergies with successful proposals under the HORIZON-INFRA-2023-DEV-01-01 topic should be sought, and collaboration with other relevant research infrastructures should be envisaged. Proposals should also be open to engage with global initiatives such as the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)^[4], the Global Health EDCTP3 Joint Undertaking^[5], or the World Health Organization (WHO).

Proposals should address the following areas:

• Fostering a trusted and proactive environment within the coordination mechanism that supports the timely exchange of research results, allows for discussion on challenges encountered in their research and finding solutions together to ensure cooperation and synergy within each network;
• Developing a common approach for the European clinical research to enable pragmatic solutions to shared challenges across European clinical trials and/or cohorts for pandemic preparedness and response, guaranteeing the best interest of European trial or study patients or volunteers;
• Promoting an optimal use of resources, based on a sound scientific approach and maximising the value added for the generation of scientific evidence, through a common baseline approach towards protocol development, harmonised and FAIR data^[6] collection and analysis leveraging existing initiatives;
• Involving relevant European stakeholders, such as representatives from regulatory authorities, industry, policymakers, patient organisations, etc., as well as relevant non-European networks and stakeholders;
• Promoting the visibility and attractiveness of European adaptive platform trials and/or cohorts for clinical investigators in Europe and beyond ; as well as active communication with the science community, patient advocacy groups and other stakeholders, to develop trust, and also promote innovative approaches;
• Partners within the coordination mechanism should develop a plan to ensure its sustainability. Coordination with the European Pandemic Preparedness Partnership and the European Health Preparedness and Emergency Response Authority (HERA) is expected.

[1]https://covid19trials.eu/en

[2]https://vaccelerate.eu/

[3]https://www.ecraid.eu/

[4]https://www.glopid-r.org/

[5]https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-innovation/edctp_en

[6]See definition of FAIR data in the introduction to this work programme part.