Partnerships: Partnerships lie at the core of EDCTP’s work. These include partnerships with funders, one example being the joint work with the Global Health Innovative Technology Fund (GHIT) on the development of arpraziquantel for pre-school-aged children. In all, EDCTP2 has leveraged financial contributions of €434 million (total cash and in kind) from global partners.

EDCTP has also signed memoranda of understanding with key bodies in sub-Saharan Africa, including the WHO Regional Office for Africa, the African Union and the Africa Centres for Disease Control and Prevention (Africa CDC). A partnership with the latter has seen more than 150 new fellows undergo Master’s training in epidemiology and biostatistics, greatly enhancing the region’s ability to monitor and respond to infectious disease threats.

Partnership of equals: Most importantly, EDCTP2 itself operates as a partnership of equals between European and African partners. The latter are fully involved in the governance and priority setting of EDCTP2, ensuring that its activities are tightly focused on the needs of the region.

Our grants portfolio has expanded to 438 grants supporting projects in 44 sub-Saharan African countries. More than 300 African and 200 African institutions are participating in EDCTP-funded projects. These numbers emphasise how embedded EDCTP2 has become in the global health arena. Most importantly, however, is the sustainable impact being achieved in these countries, in terms of strengthened national health research systems able to plan, execute and oversee high-quality clinical research, and the advancement of novel medical interventions to address the region’s unmet medical needs.

Enhancing research capacity: Activities to build research capacity in sub-Saharan Africa are integrated within clinical studies. In addition, the EDCTP2 programme also includes specific capacity-building grants schemes. The value of this approach was demonstrated during the COVID-19 pandemic, when research capacity could rapidly pivot to work on this new threat to health. Several projects added COVID-19- related activities to their existing work, while EDCTP-funded fellows made major contributions to COVID-19 responses in many sub-Saharan African countries.

The EDCTP2 fellows programme has played a vital role in building intellectual capacity in sub-Saharan Africa. A report published in 2022 summarised the programme since its launch in 2003, during which time EDCTP has invested €63.0 million through fellowship programmes, providing support for more than 400 fellows, including nearly 100 Senior Fellows, working in 40 sub-Saharan Africa countries. As those mentored by EDCTP fellows go on to supervise and support a new generation of researchers, fellows have a critical ‘multiplier’ function in developing research capacity.

As well as people and physical infrastructure, wider health research ecosystems also need to be strengthened to ensure that clinical research can be safely and ethically carried out, and new interventions monitored effectively when introduced. EDCTP2 has supported capacity building activities related to ethics review and national regulatory functions in 37 countries. Projects have had a strong focus on developing the capacity and networking of national and institutional ethics committees, to ensure protection of participants’ interests in clinical research studies. Consideration of gender-related issues has been a focus of several grants. In terms of regulatory strengthening, drug-safety monitoring has been a high priority.

Through these activities, EDCTP2 has been building capacity at individual, institutional and national levels. A joint project with WHO is monitoring national health research capacity, with recent results providing encouraging signs of improvement in overall capabilities in multiple countries.

Focus on clinical challenges and policy-relevant activities: Through extensive consultations, EDCTP2 ensures that its annually calibrated strategic research agendas reflect the priorities of sub-Saharan African countries and that research studies address questions of direct relevance to policy and practice in the region.

Important examples in recent years have included funding of a phase II study of the R21/Matrix-M malaria vaccine, the first to achieve the WHO target of 75% efficacy. With the initial results of the phase III trial reported at the American Society of Tropical Medicine and Hygiene meeting in November 2022, the vaccine has already been approved by some sub-Saharan Africa countries, and looks likely to have a huge impact on malaria prevention when introduced.

Although most EDCTP2 projects are still ongoing, some have already delivered results that have influenced global or national policy. These include the AMBITION-cm study, the results of which triggered a rapid update to WHO guidance, while the AfriKADIA project is in discussion with the WHO Guidelines Development Group for visceral leishmaniasis. In malaria, the latest WHO guidelines make a strong recommendation for the use of pyronaridine–artesunate (Pyramax), for which key data were generated by EDCTP-funded networks.

In September 2022, EDCTP organised a side event at the Science Summit of the 77^th United Nations General Assembly (UNGA77), showcasing examples where EDCTP-funded projects had generated data that informed local and national guidelines. The event also provided an opportunity to highlight the importance of international partnerships to catalyse collaborative research focused on nationally and globally significant threats to health.

Implementation research and uptake: Although the demonstration of safety and efficacy in clinical trials is essential, it does not guarantee the introduction and uptake of new interventions. Additional data may be required by policymakers and implementation research studies may be needed to identify the most effective strategies and delivery systems of new interventions. In recognition of this critical gap, EDCTP2 also supports preparatory and implementation activities, including product-focused implementation research.

Notable examples include the ADOPT study, which is laying the ground for introduction of arpraziquantel for pre-school-aged children, and the DREAMM project, focused on new approaches for diagnosis and clinical management of central nervous system infections, such as cryptococcal meningitis, in people living with HIV. In addition, the LeishAccess project is working with ministries of health to promote greater use of Leishmania treatments, including a new therapy evaluated through the AfriKADIA project. The PEP4LEP project is comparing two strategies to prevent transmission of leprosy within affected households.

This area of work also provides opportunities to explore synergies with bodies working on complementary areas of development assistance. For example, two joint calls on strengthening of health systems and maximising the impact of research on reducing disease burdens leveraged an additional €23 million from bodies including Gavi, the Vaccine Alliance and the US Agency for International Development (USAID).

Neglected populations: EDCTP2 has had a strong focus on populations that are typically excluded from clinical trials, such as infants, children, adolescents, pregnant women, and people with co-infections and co-morbidities. Of the clinical studies funded through EDCTP2, 14% involve pregnant and lactating women and their offspring, 26% involve newborns and infants, and 35% involve children as well as adolescents.

For young children, important examples include the development of arpraziquantel for pre-school-aged children through the PZQ4PSAC and ADOPT projects, moxidectin for onchocerciasis through the MiniMox project, acoziborole for human Africa trypanosomiasis through the ACOZI-KIDS project, and several projects aiming to extend antimalarial use to paediatric populations (PAMAFRICA, DPP, WANECAM2). Additional projects are testing new regimens and formulations of antiretrovirals for children (e.g. CHAPAS 4, UNIVERSAL). Two projects, PediCAP and EMPIRICAL, are testing interventions to improve the treatment of pneumonia in children in the community and in hospitals. 

Multiple projects are enrolling pregnant and lactating women into trials. These include studies evaluating antimalarials (e.g. MAMAH, IMPROVE and IMPROVE-2 and PYRAPREG projects) and interventions to increase uptake and coverage of preventive malaria therapy in pregnancy (Revive IPTp). New approaches are being explored for HIV prevention in women, including broadly neutralising antibodies (CAP012 SAMBA project)  and behavioural studies of attitudes to pre-exposure prophylaxis (UPTAKE). The PREGART project is testing antiretroviral regimens for prevention of mother-to-child transmission and treatment of HIV-infected pregnant and breastfeeding women.

For adolescents, the CHAPS study is focusing on pre-exposure prophylaxis in male and female adolescents, while the BREATHER-PLUS project is evaluating alternative treatment regimens for adolescents on antiretroviral therapy.

Co-infections are a particular issue for people living with HIV. The AMBITION-cm trial has delivered critical evidence on the benefits of a new treatment for cryptococcal meningitis, one of the most common causes of death of people with HIV infections. The DATURA study is investigating whether intensified treatment of TB can reduce alarmingly high mortality rates in people living with HIV.

A key contributor to EU–Africa partnerships: EDCTP has become the focal point of EU activities relating to poverty-related infectious disease research. Moreover, EDCTP2 provides a model for the organisation of highly productive partnerships between the two regions. This function was acknowledged in the recommendations made by the Advisory Group on Research and Innovation (R&I) for Africa–Europe Cooperation in February 2022, which highlighted the role played by EDCTP in strengthening capacity in Africa and described EDCTP2 as “the most cited joint programme strengthening health research and health systems in Africa and the flagship EU-Africa partnership in health R&D cooperation, with large successful, long-lasting research networks”.

In addition, the multi-annual strategic research agendas developed by EDCTP2 provide a framework for alignment of centrally managed activities across member states. By pooling resources, member states can achieve substantially more than they could by acting independently. Participating states-initiated activities, PSIAs, are country-funded activities that align with EDCTP2 goals and objectives and, alongside centrally managed grants, make a major contribution to the wider EDCTP2 portfolio of projects.

Collectively, these projects are making a key contribution to the twin aims of EDCTP2 – to advance the development and implementation of new medical interventions against poverty-related diseases and to build the health research capacity of countries in sub-Saharan Africa. EDCTP2 impact has been based on its ability to catalyse the formation and strengthening of international partnerships between institutions in Europe and sub-Saharan Africa, and increasingly with input from additional countries, and encompassing both academic institutions and product development partnerships.

Launched in 2014, EDCTP2 set itself challenging targets in its efforts to advance the development of medical interventions against poverty-related infectious diseases affecting sub-Saharan Africa, while simultaneously strengthening clinical research capacity in the region. As we reach the nine-year mark, it is a timely moment to take stock and to consider how EDCTP2 investments – €824 million to date – are contributing to the fight against poverty-related infectious diseases, now and into the future.

It was pleasing to read the second interim evaluation of the EDCTP2 programme, undertaken by an independent review panel in 2022. The evaluation concluded that EDCTP2 is now “well-established and recognised globally”, with EDCTP2 now “one of the most prominent funders of clinical studies in sub-Saharan Africa”. In several areas, EDCTP2 is one of the foremost global funders of clinical research and associated capacity development.

It has achieved this position by being very intentional and strategic in its funding and by adhering closely to a core set of principles, laid out in the EDCTP2 Strategic Business Plan, which have enabled EDCTP2 to carve out a unique niche in the global health research landscape. In each of the areas listed below, EDCTP2 has made substantial progress over the past nine years.