However, preparatory activities conducted during the preclinical phase can be considered in scope if they enable the conduct of the clinical study/ies in scope (these activities include but are not limited to protocol writing, development/evaluation of laboratory tests, Chemistry, Manufacturing, and Controls (CMC) related activities, etc.).

For all Global Collaboration Actions such as this topic, proposals submitted are expected to leverage financial and/or in-kind contribution from contributing partners. Proposals should define the activities of their project in its entirety, including details of the component(s) for which Global Health EDCTP3 funding is requested and the component(s) that are to be financed by contributing partners. Each contribution should be well described and budgeted in each proposal, so that the activities and related costs that are covered by the in-kind or financial contribution(s) are clearly identified.

Applicants need to concisely describe any prior relevant research findings and explain how the proposal builds on available data (including data generated in scope of earlier EDCTP programmes if available). Full details of the development milestones, including specific go/no-go criteria for the implementation of the proposed clinical trial(s) must be included, as well as specific plans for the subsequent regulatory approval process, which should aim at obtaining relevant market authorisation. and an access strategy that will allow patients in low-resource settings to access the final product.

The applicants are encouraged to consider the latest innovations and advances in the clinical trial design and research methods to evaluate promising interventions allowing shorter development timings. Applicants are also encouraged to follow the WHO Guidance for best practices for clinical trials.

Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers or clinical Investigators, health care professionals, policy makers, public health authorities and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines and are encouraged to follow guidance provided in the EDCTP Knowledge Hub Research into Policy Toolkit.

Where possible and relevant, collaboration and coordination with the AU-EU Health Partnership’s –Manufacturing and Access to Vaccines, medicines and health technologies (MAV+) hub or similar African initiatives is encouraged. The applicants could show, for example, willingness to enter into technology transfer agreements with their counterparts – including the provision of patents, technical knowledge and know-how, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from SSA countries, including active participation of Franco/Lusophone countries, if possible. Collaboration with other international research groups with relevant experience is very much encouraged. Applicants are also reminded of the expectation of reaching out to institutions/organisations in countries with high disease burden but with relatively lower research capacities.

Post-Exposure Prophylaxis (PEP) research – leprosy focus

In the context of studies on TB post-exposure prophylaxis, the Leprosy Research Initiative will co-fund one or more projects also targeting leprosy post-exposure prophylaxis (PEP), for instance, through integrated implementation of PEP or by evaluating or validating a uniform PEP regimen for both diseases in a clinical trial. The objective and funding of the leprosy-related objective is to be included in the proposal with a total indicative JU budget of 5 million EUR. The selected project(s) will contribute to advancing knowledge and strategies for PEP in the context of TB and leprosy, aligning with broader institutional goals in infectious disease control.