Implementation research/real life assessment of existing interventions in women and children’s health
According to the 2022 report of the World Health Organization, more than half of the world’s maternal deaths occur in SSA, where the rate stands at 525 deaths per 100 000 live births and 27 neonatal deaths per 1000 live births[1]. Current trends show that by 2030 the region will still record 390 maternal deaths per 100 000 live births and 54 neonatal deaths per 1000 live births, very far from the targets set by the Sustainable Development Goals (SDGs). The factors contributing to maternal and child deaths are numerous.
In countries in SSA, infectious diseases remain the leading causes of morbidity and mortality, especially during pregnancy and childhood. Because of limited evidence on the contribution of these diseases to maternal and neonatal mortality, the importance of PRDs for maternal, foetal, and neonatal deaths is often poorly recognised. Despite the progress made in other age groups, effective treatment and prevention of PRDs and other diseases such as diarrhoeal diseases, bacterial infections (especially those where antimicrobial resistance is an issue), sepsis and lower respiratory tract infections in mothers, newborns and children is often lacking and/or lagging. The frequent exclusion of pregnant women and children from clinical trials and the limited number of available products targeting these groups, are factors that contribute to the lowest health indicators in these vulnerable populations. In addition, there is a need for critical appraisal of existing health interventions, which may have been introduced and used by healthcare systems without rigorous evaluation in clinical trials. It is thus important to understand whether such interventions lead to better overall health in these populations.
Moreover, failure to translate research findings into policy and practice prevents research from achieving maximum public health benefits. Despite substantial investment in clinical research in infectious diseases, including PRDs, exploitation, and use of results beyond research groups to date remains limited. Barriers to an efficient uptake of research findings include limited interaction between researchers, policymakers, patients’ community and other stakeholders, lack of experience in exploiting research results beyond academia, limited health systems capacity, affordability issues, and differences between the research, programme planning and policymaking structures and actors.
Concerted efforts are needed to increase access to potentially lifesaving, cost-effective interventions to prevent and treat PRDs and other diseases such as diarrhoeal diseases, bacterial infections (especially those where antimicrobial resistance is an issue), sepsis and lower respiratory tract infections in pregnant women, newborns, and children to ensure solid evidence is produced for the recommended interventions and to enhance the use of existing interventions in these populations.
Proposals should address the following activities:
- Carry out registration (phase III) and/or post-registration studies of health technologies that tackle infectious diseases affecting women and children to demonstrate clinical effectiveness;
- Demonstrate the cost-effectiveness of the health technologies being investigated in the relevant populations and communities;
- Identify the barriers to the uptake of the health technologies under investigation and address them in the proposed studies;
- Develop methods that can ensure translating clinical research results into healthcare policy and practice in a SSA setting. These methods should be broadly applicable to improve patients’ quality of life beyond the specific health technology being investigated;
- Early involvement and regular interaction with policy- and decision-makers, including end-users, to ensure adoption of the health technology by health systems in SSA.
This call is restricted to the following diseases: HIV, malaria, tuberculosis, diarrhoeal diseases, bacterial infections (especially those where antimicrobial resistance is an issue), sepsis and lower respiratory tract infections.
The research carried out and the health technologies developed in the study should tackle infections affecting the health of pregnant women and children up to five years of age.
Neither pre-clinical research nor early-stage clinical trials in the context of product development are within the scope of this call.
Applicants need to concisely describe any proven research evidence of previous findings and explain how the proposal builds on these results. Building on results from projects supported under previous EDCTP programmes is encouraged.
Proposals should present a sound assessment of the feasibility of the proposed work, in particular as regards the proposed clinical interventions. Realistic plans for recruitment of subjects (as part of the clinical trial plan with projected dates) should be presented and documented by demonstrated success from previous studies. The proposals should justify the choice of populations to be enrolled into the interventions. Relevant determining characteristics (such as socio-economic status) also need to be considered.
Proposals must assure that the clinical trials are conducted in line with national and international standards of research, to comply with current legislation, Good Clinical Practice, ethics, and safety-related issues, as well as Good Manufacturing Practice, as relevant.
Proposals should describe how stakeholder views of the proposal’s relevance and the study design have been incorporated into the work plan of the research proposal. Proposals should indicate explicitly the plans for good participatory practices for engaging stakeholders at every step of the research life cycle.
Proposals should provide details on the methodology for linking clinical research aspects with the translation into healthcare practice and policy.
Proposals are expected to come from research consortia with a strong representation of institutions and researchers from African countries, including involvement of franco/lusophone countries where possible and relevant.