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:
- A diverse and comprehensive EU landscape of multi-country adaptive platform trials (i.e. able to study multiple interventions in a disease or condition in a perpetual manner, thus allowing modification to the trial after its initiation without undermining its validity and integrity) that assess vaccines and therapeutics for infectious diseases, and have the capacity to pivot rapidly in the case of epidemic or pandemic health threats.
- Innovative and improved design of clinical studies, suited for pandemic preparedness, is available for the clinical research community, taking into account the high safety standards in the European regulatory environment.
- Trial sites across multiple countries have the capacity to deliver robust clinical evidence in a diverse European population, using harmonised research methods, data collection and analysis.
Scope:
As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Health threats are expected to arise due to among others, climate change, and thus a need for proactive approaches to ensure timely availability of medical countermeasures during disease outbreaks is anticipated. The conduct of perpetual adaptive platform trials, with the in-built agility to pivot when an epidemic strikes, is key to be prepared for infectious disease epidemics or pandemics.
This topic aims to provide funding to adaptive clinical platform trials that may be implemented routinely outside of an epidemic or pandemic context, but that are designed to be ready for the timely assessment of novel diagnostics, therapeutics or vaccines in the face of an epidemic or pandemic.
Proposals should develop the wide range of elements needed to sustain multi-country adaptive platform trials, including the trial implementation capacity, laboratory analysis capacity, and a harmonised approach to the collection, storage, sharing and analysis of FAIR[1] data.
Proposals should ensure timely engagement with regulatory authorities and bodies. Proposals should consider the European regulatory environment and take full use of the European capacity to deliver quality trials, including the possibility for registration of new medical products. Proposals should strengthen the leading role of the EU in clinical research preparedness for future epidemics and pandemics.
The proposals should address the following areas:
- Development of robust clinical evidence that contributes to the knowledge base for the diagnosis, treatment and prevention of infectious diseases. Sex, gender, age, ethnicity and socio-economic factors should be taken into account.
- Known hurdles related to ethical, administrative, regulatory, legal and logistical aspects should be anticipated and addressed to the extent possible, in order to avoid such barriers when the trial needs to pivot in response to an epidemic or pandemic.
- Engagement with clinical researchers and biostatisticians, to increase capacity for the design and implementation of adaptive platform trials across Europe.
Collaboration and coordination with existing adaptive platform trials in the EU is expected, where relevant, as well as with the coordination mechanisms established under topic HORIZON-HLTH-2023-DISEASE- 3.05 and with the European Medicines Agency (EMA). Collaboration and coordination with other organisations and other regional and global initiatives, such as Global Health EDCTP3 Joint Undertaking[2], the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)[3], the European Pandemic Preparedness Partnership and the European Health Preparedness and Emergency Response Authority (HERA) should be envisaged. International cooperation is encouraged.
This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
[1]See definition of FAIR data in the introduction to this work programme part.
[2]https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-innovation/edctp_en
[3]https://www.glopid-r.org/
