Dr Michael Makanga is the Executive Director of the EDCTP, an EU-African partnership that provides over €750 million in funding to clinical research to detect, treat and prevent poverty-related diseases in sub-Saharan Africa. He is a clinician-scientist from Uganda with 26 years of professional experience working on health and poverty-related diseases in sub-Saharan Africa.
Hear him recount how EDCTP rapidly released funding for researchers across sub-Saharan Africa to fight the COVID-19 emergency, and sprouted landmark partnerships for clinical research.
Following the sudden outbreak of the novel Coronavirus disease (COVID-19) in December 2019, there was an unprecedented rapid spread of the disease across over 183 countries with more than a million confirmed cases globally. The World Health Organization (WHO) characterised COVID-19 as a pandemic in March 2020, following alarming levels of infection, disease severity and death.
Against the backdrop of the rising numbers of cases reported from affected countries across Africa and the limited regional research, there was a major risk of sub-Saharan Africa being left behind. Consequently, the European & Developing Countries Clinical Trials Partnership (EDCTP) activated its emergency funding mechanism to support Research & Innovation Action as part of the European-African response to the COVID-19 emergency. This mechanism permitted a rapid and coordinated mobilisation of research funding based on a call for expressions of interest in exceptional and justified emergencies. In April 2020, EDCTP invited proposals to support research activities in sub-Saharan Africa to manage and/or prevent the spread of COVID-19. This emergency funding call was open for only 14 days and resulted in a record number of proposal submissions in a single-stage call for proposals with an accelerated review mechanism.
Over 150 applications were received, of which 100 were eligible for scientific evaluation. The consortia which were assembled in just a few days to respond to the call and the high quality of applications indicates the growing strength and competitiveness of the clinical research community in sub-Saharan Africa (SSA) which is further bolstered by international collaboration.
The infographic depicts the geographical distribution of the 27 consortia that received EDCTP emergency funding support — of 23 countries 13 are led by sub-Saharan African institutions. These consortia galvanized leading scientific minds and research institutions from a wide array of geographical locations to unify their good intentions to address critical research gaps in several thematic areas such as:
- Understanding the natural history of infection to better define the period of infectiousness and transmissibility; improve surveillance capabilities to more accurately estimate the reproductive number in various outbreak settings and improve understanding of the role of asymptomatic infection in transmission.
- Promote the development, adaptation, evaluation, and implementation of point-of-care diagnostic tests that can be used to screen all patients presenting with a history consistent with COVID-19 infection.
- Support standardized, best evidence-based approaches for clinical management and better health outcomes for patients by contributing to the implementation of randomized, controlled trials for diagnostics and therapeutics as promising agents emerge, taking usability, including multi-center/country trials and access in resource-constrained settings, into account.
- Validation and adaptation of existing serological tests, including those that have been developed by commercial entities, and establishment of biobanks and serum panels of well characterized COVID-19 sera to support such efforts.
The bad: risks to research in times of global crises
There were many challenges the EDCTP and the research field in general faced during the COVID-19 crisis, not limited to:
Lengthy approval process and strained oversight of ongoing research
- Extended timelines for ethical and regulatory approvals because of lockdown measures
- Limited domestic funding, increased workload and protocols on COVID19 with new trial designs prioritised over other diseases
- None or limited monitoring visits for regulatory trials; site initiation visits postponed.
Disruption of clinical research activities and enrolment
- Lengthy, repeated suspension of recruitment into clinical trials and studies due to lockdown measures
- Shortage of human resources (e.g., increased task sharing, staff illness, death, mental health)
- Closure of institutions and restrictions on meetings leading to a cessation in project activities incl. outpatient clinics, routine immunisation services and home visits.
Disruption of routine and research laboratory services
- Travel restrictions affecting transport of essential equipment, investigational products, reagents and equipment, and samples for analysis.
In addition, there was the ‘Covidization of research’* across the globe. Researchers expended significant energy pivoting their work to the COVID-19 response, resulting in tremendous redundancy and wastage. The lowering of normal scientific standards and bad science, combined with poor science communication, is eroding public faith in research and misleading policymakers.
Preparedness and resilience: new collaborations in public health
EDCTP has a long-standing partnership with the WHO Regional Office for Africa. In 2021, it also strengthened its ties with the African Union, signing a landmark memorandum that will see close collaboration on the key health issues facing the region, particularly in relation to infectious disease control and preparedness for disease outbreaks, epidemics and pandemics. A critical element of this partnership involves a close working relationship with the Africa CDC. The most noteworthy aspect of this partnership was the award of funding to ten consortia in 2021 that have established training programmes for 151 epidemiologists and biostatisticians. These programmes are training a new generation of experts to make an important contribution to the monitoring and response of existing and new infectious disease threats across a wide swathe of countries in sub-Saharan Africa, including those with a high disease burden but currently underdeveloped health research system.
The EDCTP’s Emergency COVID-19 response call has inspired and informed the development of the COVID CIRCLE “Seven Funder Principles”, agreed by the UK Collaborative on Development Research and GLOPID-R (a global coalition of research funders), to coordinate efforts for research funders to support high-quality research for the most pressing global needs in epidemics and pandemics.
These seven funder principles aim to address good practices in relation to:
- Alignment to global research agendas and locally identified priorities
- Research capacity for rapid research
- Supporting equitable, inclusive inter-disciplinary and cross-sectoral partnerships
- Open science and data sharing
- Protection from harm
- Appropriate ethical consideration
- Collaboration and learning through enhanced coordination.
Lessons for the future
At the outset of the COVID-19 pandemic, research funders recognised the need and urgency to strategically align and coordinate COVID-19 research funding at all levels to minimise duplication and fragmentation of efforts, and maximize impact in resource-constrained settings. The well-intended lockdown control measures disrupted clinical research activities, making it challenging to follow-up study participants that were already enrolled in clinical trials. This could have jeopardized safety of individuals, whilst independent monitoring of project progress and compliance was severely limited during the pandemic. Thanks to the implementation of innovative solutions such as digital technology, such potential serious risks to ethics and integrity of the research were swiftly averted.
Call to action
As research and development funders, we must remain mission-focused especially in times of sudden global crises. This means strengthening our own preparedness and resilience through increased long-term perspective strategic planning, relentless curiosity, and data-driven course-adjustments. We must cooperate to ensure compliance to the available global set of standards and good practices covering research in emergency situations. We know that the PREPARED initiative will help to contribute to this field in areas where we still have gaps in ethics and integrity of the research during emergency situations.
*Pai, M. Covidization of research: what are the risks? Nat Med 26 , 1159 (2020). https://doi.org/10.1038/s41591 020 1015 0