Call summary :

Expected Outcome:

Within the scope of diarrhoeal diseases of the Global Health EDCTP3, this topic aims to reduce or manage the potential adverse consequences for diarrhoeal diseases by contributing to at least two of the following expected outcomes, with the first being mandatory:

- Develop interventions to identify and control diarrhoeal diseases through generating late-stage clinical data in sub-Saharan Africa;
- Implementation research combining interventions with current standard of care (including vaccines);
- Generate evidence to evaluate the populations and geographies of most vulnerable to diarrheal diseases, understand the key underlying factors including those related to climate change, and understand the barriers to protect the people affected.

Scope:

The scope of this call is anchored in the Global Health EDCTP3 SRIA.

The proposals are expected to generate late-stage clinical data evaluating safety, efficacy and clinical utility accelerating the development of novel or existing treatment against DDs or focus on late-stage development of novel or existing diagnostics to detect DDs. The scope limits to the following pathogens: rotavirus, shigella, cholera, enterotoxigenic E. coli, cryptosporidium, and norovirus. Solutions having the potential to reduce AMR are considered in scope. Other DD pathogens are out of scope of this call.

Where appropriate, proposals are encouraged to include implementation research combining interventions with current standard of care (including vaccines), as well as complementary research components that help to improve the understanding on how diarrhoeal diseases are currently influenced by climate and weather and may be further exacerbated by climate change (WHO Technical series on adapting to climate- sensitive health impacts: diarrhoeal diseases[1]).

Multidisciplinary approaches integrating adjacent sectors are strongly encouraged (i.e. nutrition, IPC/WASH). Proposals are to generate clinical data serving new-borns, children, people with co-infections and co-morbidities and other vulnerable and neglected populations at risk in SSA when relevant.

Applicants are expected to provide methodologies for translating research findings into public health/climate practice and policy guidelines.

When relevant, proposals should clearly describe the desired target product profile. 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 new adaptive trial designs and lessons learnt from COVID-19 potentially allowing for shorter development timelines.

Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers, 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.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement 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 organisations in countries with relatively lower research capacities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, such as external conferences, workshops or symposiums for an exchange of knowledge, and bestpractices with external collaborators....