Among major institutional funders in global health, only one focuses exclusively on financing clinical research and supporting scientists in Sub-Saharan Africa: the European and Developing Countries Clinical Trials Partnership (EDCTP), a partnership between African and European countries co-funded by the European Union (EU). Why is the EDCTP so involved in using research to bring much-needed drugs to patients in the region? We wanted to know more.
African sleeping sickness, known as human African trypanosomiasis (HAT) has historically been a deeply neglected disease, but the rhodesiense variant of the disease is even more neglected. While the gambiense variant found mostly in the Democratic Republic of Congo (DRC) has seen more awareness, funding, and innovation the past years, rhodesiense is deadlier but represents only 15% of the total burden. This has proven frustrating for researchers.
‘We struggled for years to find funding to develop a new treatment – even though existing treatments are highly toxic,’ said Dr Olaf Valverde, Clinical Project Leader at the Drugs for Neglected Diseases initiative (DNDi). Luckily an innovative partnership known as EDCTP exists to support exactly this type of research.
Eventually DNDi was able to receive EDCTP funding to launch the HAT-r-ACC project, which includes a clinical trial now being carried out in Malawi and Uganda to evaluate the efficacy of the drug fexinidazole against rhodesiense.
‘Our clinical trial would never have existed without EDCTP’s support,’ said Dr Valverde. Dr Nathalie Strub-Wourgaft, Director of Neglected Tropical Diseases (NTDs) at DNDi, agrees. ‘There are few patients but the impact of the trial in terms of potential benefits for the affected population is immense,’ she said.
The EU is one of the world’s largest public funders of medical research. EDCTP was created in 2003 as a partnership between 17 Sub-Saharan African and 14 EU countries(1). Its funding(2) comes from the European Commission, participating countries, and public and private partners (third parties). It is focusing on funding medical research in Africa – initially HIV, TB, and malaria, with the important addition of NTDs a few years later.
‘Infectious diseases are the largest causes of death and ill health, and affect the productivity of the population in affected countries. These diseases are really holding them back,’ explained Dr Michael Makanga, Executive Director of EDCTP. ‘As a key driver to the diagnosis, prevention and management of infectious diseases, medical research is therefore directly related to people’s well-being and economic development.’
A perspective echoed by Dr Anthony Solomon, Chief Scientist at the World Health Organization’s (WHO) Department of Control of NTDs, during a session of the Tenth EDCTP Forum held this week in Mozambique: ‘NTDs are ‘diseases of poverty’ and investment in them is one of the most economically effective of all available tools in global health,’ he said. ‘Such intervention can deliver powerfully effective results.’
DNDi is currently involved in seven EDCTP-funded projects, including a consortium to find improved health tools for visceral leishmaniasis in Eastern Africa.
Among the many examples of other successful EDCTP-supported programmes, Michael Makanga highlights the Pediatric Praziquantel consortium, which is developing a child-friendly formulation of a treatment for schistosomiasis and which brought together research institutes on three continents, Japanese and German pharmaceutical companies, and the Ministries of Health of Côte d’Ivoire, Kenya and Uganda(3).
After the phase III work was done [phase III clinical trials evaluate how well a treatment works compared with a standard treatment], the Praziquantel project attracted another round of funding, this time to develop a child-friendly formulation of the treatment. ‘The strong engagement of the African partners in countries where the work is being done has been crucial,’ said Dr Makanga.
Such a strong level of ownership is by design: EDCTP was created as a partnership with equal engagement from Sub-Saharan and European countries. For each project it supports, EDCTP requires the active involvement of African organizations and leaders. ‘This is a virtuous model that aligns perfectly with our own approach and philosophy about research on NTDs,’ said Dr Strub-Wourgaft. ‘This is the collaboration model DNDi is advocating. With EDCTP, we speak the same language.’
These collaborative partnerships support the second core objective of EDCTP action: capacity building. With less than 200 researchers per million people in 2017 (compared to more than 4 000 in US or UK), Africa needs more trained scientists to develop its full potential in science and innovation. EDCTP has supported more than 1400 postgraduate long-term training for African scientists, the majority of whom are continuing their careers in Africa. Over 26,000 people have been trained through short-term trainings in EDCTP projects.
This figure does not include the hundreds more scientists organically trained in the field, in the context of EDCTP-funded clinical trials. For example, DNDi’s HAT-r-ACC project involves medical teams in provincial hospitals with no previous experience in clinical research. The EDCTP grant included training in clinical studies, protocol and procedures. ‘Such competences are actually having a spillover effect because they also end up improving patients care,’ said Dr Valverde.
EDCTP is also contributing to institutional capacity in terms of the regulatory environments and ethics, so national authorities are better equipped to cope with the growing complexity of clinical studies.
‘In terms of the importance of capacity building, the COVID-19 pandemic was really an eye-opener,’ said Dr Makanga. ‘Many scientists involved in the conduct of clinical trials in Africa have been called to join the national advisory COVID-19 committees of their governments and have played a crucial role in identifying local priorities in the pandemic response of their countries. The expertise they developed in different diseases was put to good use when combating COVID-19.’
Infrastructure matters too. ‘Countries with better integration of research with national health systems, and with robust health and demographic surveillance systems developed for other diseases, have responded much better to the pandemic,‘ said Dr Makanga. ‘The COVID-19 calamity might therefore encourage policy-makers and influential people to look at research as an important driver for the well-being of the populations and their economic development.’
Looking at the future of research on the continent, the EDCTP director does not hide his optimism and enthusiasm: ‘Scientific excellence and leadership are growing. We have a new generation of researchers with the ability to initiate research ideas, who are globally connected and able to tap into outside resources to conduct local research of global relevance. To me, that is very exciting.’
‘We are building a generation of scientists who are going to transform the research environment in Africa. The work we are doing has a multiplier effect that is changing the lives of the research communities in the countries… and that is, ultimately, transforming the lives of people.’
(1) The 16 African member countries are Burkina Faso, Cameroon, Congo, Ethiopia, Gabon, The Gambia, Ghana, Mali, Mozambique, Niger, Nigeria, Senegal, South Africa, Tanzania, Uganda, and Zambia. The 14 European member countries are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, and UK. Angola and Switzerland are aspirant members.
(2) The EDCTP programme is supported by the European Union’s Framework Programme for Research and Innovation, called Horizon 2000. Horizon 2020 will provide up to €683 million for the current EDCTP programme (2014-2024), provided this is matched by contributions from the European EDCTP partner countries.
(3) Full list of partners here: Consortium partners | Pediatric Praziquantel Consortium
Photo credit: Emmanuel Museruka-DNDi; Nathalie Strub-Wourgaft-DNDi