This is the second work programme under the Global Health EDCTP3 (European and Developing Countries Clinical Trials) Joint Undertaking (GH EDCTP3). HORIZON-JU-GH-EDCTP3-2023-02-two-stage covering two topics for Research and Innovation Actions (RIA), both of them due the 28^th September 2023 first stage.

European and Developing Countries Clinical Trials Partnership (EDCTP) exists to accelerate the clinical development of new or improved medicinal products for the identification, treatment and prevention of poverty-related and neglected infectious diseases, including (re-)emerging diseases. In addition, the EDCTP funds activities for research capacity building in Africa, supporting researchers' careers and strengthening national health research systems.

The work programme this year puts particular emphasis on capacity building and training. A topic calling for training networks is included (GH-EDCTP3-2023-01-01). Also, for the other topics in the work programme, where relevant, support of African scientists through degree training in clinical research and/or hands on training during implementation of research projects should be provided to assist them in advancing their scientific careers. These scientists should be selected keeping gender balance in mind. In the context of this work programme, a clinical study covers clinical studies/trials/investigations/ cohorts and is defined as any systematic prospective or retrospective collection and analysis of health data obtained from individual patients or healthy persons to address scientific questions related to the understanding, prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical condition.

• HORIZON-JU-GH-EDCTP3-2023-02-01-two-stage: Improving modes of delivery, deployment, and uptake of vaccines through phase IV/implementation research

Scope:

• Carry out phase IV/implementation research studies on the deployment and uptake of registered vaccines43 in SSA, examining operational aspects, access, coverage, vaccine acceptability/hesitancy, community engagement, real-life impact on overall health and cost-effectiveness;
• Develop and test novel logistical solutions for vaccination;
• As relevant, develop and test novel clinical solutions for vaccine delivery, including new delivery modes;
• Gain a better understanding of different health care systems in sub-Saharan Africa as regards the factors driving structural inequalities in vaccine deliveries;
• Identify the social, economic, political, religious, cultural, and personal factors driving vaccine hesitancy in SSA and develop targeted solutions, as appropriate. Vaccine hesitancy should be considered in the context of the specificities of different types of vaccines and their perceived risks and benefits. It is further essential to investigate the factors that are undermining coverage in different countries, regions, or communities both in terms of vaccine types and doses received. In many cases, this means targeted collaborations with local leaders who can effectively address their communities' concerns and with caregivers who bring children to vaccination services. Applicants are also encouraged to develop evidence-based tools that can guide people towards informed vaccination decisions, delivering tailored information based on each user's concerns;

Budget per proposal: around 5 million euros, expected 6 projects finance. 

• HORIZON-JU-GH-EDCTP3-2023-02-02-two-stage: Advancing point-of-care diagnostics to the market

Scope:

• Clinical performance studies in several sites across SSA of POC diagnostics that are of high technology readiness level to achieve regulatory approval and market launch (i.e., CE mark); postmarket surveillance studies are excluded from this call and are covered by other initiatives such as the African Health Diagnostics Platform46;
• Studies need to provide evidence-based practice for the POC diagnostic test especially in terms of the ability to decide on treatment options after diagnosis and improving disease outcome; the possibility of the POC diagnostic to be deployed in the field, its usability by primary care and community health care workers in resource-limited patient communities should be especially considered;
• Inclusion of a clear regulatory path to market to ensure future compliance with the legal requirements; early engagement with regulatory authorities is expected;
• Product development plans for translation from prototype to industrial design, to implementation and sustainability of the innovation should be provided, also including a plan for the process of "sample to result to the use of result & treatment option" and how to report data & results (e.g., via mobile health/portable technology);
• Where available and relevant, World Health Organization target product profiles for diagnostics need to be addressed;
• Involvement of industry, notably of small and medium-sized enterprises (SMEs), especially African SMEs, is expected. Involvement of African SMEs is highly encouraged to contribute to developing the African industry and access to health products.

Budget per proposal: around 5 million euros, expected 5 projects finance. 

Due to the fact that each topic has different requirements, please consult frecerca.internacional(ELIMINAR)@sjd.es or check the Work Programme. 

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