Only ~20% of the attendees in our recent webinar, Africa’s Potential for Clinical Research, had been involved with research conducted in Africa, and an additional 40% had conducted no more than five studies. At FHI Clinical, we see this as a missed opportunity for many organizations developing medicines and vaccines to take advantage of experienced, knowledgeable sites and investigators and to access unique populations, many of whom would benefit from investigational interventions.
How much experience do you have conducting research in Africa?
With experienced researchers and sites, investment in research infrastructure by local and overseas organizations as well as engaged stakeholders, Africa should be a research destination for pharma, biotech, government and non-governmental organizations alike. Here, we discuss how research capacity has matured in sub-Saharan Africa (SSA) specifically over the last couple of decades.
Research portfolio is flourishing
The number of clinical trials being conducted in SSA has grown exponentially since 2000, according to a search of trials registered at clinicaltrials.gov. In addition to the infectious disease trials most commonly associated with the region, such as tuberculosis (TB), malaria and HIV, a large percentage of trials have been conducted for non-communicable diseases such as diabetes, heart disease and others.
The number of clinical trials and range of indications being studied have significantly increased.
Based on our experience with research across therapeutic areas in SSA, we’ve found that skills and strategies developed during infectious disease trials—such as frequent, long-term follow-up of participants, community mobilization and cold chain storage in limited-infrastructure areas—have equipped local researchers to be successful in trials of all types. After all, if high-quality data can be produced in the challenging situations encountered during infectious disease outbreaks, doing the same during trials with less complexity is relatively easy.
Due to this success, research conducted in SSA has contributed to important findings for the global community, such as these recently published studies that FHI Clinical has supported in SSA:
The top 10 countries in sub-Saharan Africa by number of registered clinical trials in 2010-2020 were:1
- South Africa
- Nigeria
- Kenya
- Uganda
- Tanzania
- Malawi
- Ethiopia
- Ghana
- Zambia
- Zimbabwe
Research capacity is growing with local investment
A major contributor to greater research output is increased commitment by local SSA governments and organizations to foster research and innovation. It is likely that policy recommendations from SSA-led studies will continue to have greater relevance and that greater SSA-initiated research output will encourage young researchers and increase national and international visibility of African scientists and research institutions. The commitment to facilitating research in SSA is reflected in Africa Health Strategy 2018 to 2030, which aims “to facilitate coordinated, sustainable and responsive health research and innovation that will provide effective interventions for health in Africa” and outlines the following key strategies:2
- Strengthen capacity for sustained, integrated, coordinated and collaborative research, innovation and translation for health
- Develop and implement sustainable mechanisms for investment and financing in research and innovation for health
- Generate new knowledge aligned to health goals and targets and advocate for its translation into products, services, policies and practices to improve health
- Strengthen data-sharing platforms and systems to optimize health delivery
- Advocate for the adoption of emerging technologies and supporting platforms to improve health
- Strengthen and harmonize regulatory, ethics and intellectual property systems in order to maximize the benefits from African-led research and innovation for Africa and the global community
- Maximize the benefits from African-led research and innovation for Africa and the global community through robust research regulatory and intellectual property systems
The first priority in this plan is development of human capacity to increase both the number of researchers and their distribution across the continent. Strategies to achieve this priority include updating universities’ curricula on health research, linking public and private sectors to prioritize research areas and agenda, establishing and strengthening research career development paths and strengthening training capacity.
Mentorship of new researchers has also played an important role in developing early-career investigators. In our webinar, Dr. Mookho Malahleha, CEO of Synergy Biomed Research Institute in South Africa, described her personal experience with mentorship as a young researcher.
As a young doctor working in a tuberculosis (TB) and HIV clinic in rural KwaZulu-Natal, South Africa, she wanted to contribute more to advancing healthcare and joined a center involved in clinical trials.
Dr. Mookho Malahleha, MBChB, MPH
CEO, Synergy Biomed Research Institute
Initially working in Themba Lethu on an observational trial of disease progression in HIV-infected individuals, she later joined the Setshaba Research Centre. During her 12 years at this center, she received considerable mentoring and extensive research experience in infectious diseases as well as non-communicable diseases. A memorable experience was as co-chair of an HIV vaccine trial (HVTN 702) with internationally renowned researchers Professor Glenda Gray, Professor Linda Gail Bekker and Dr. Fatima Laher. Based on their mentorship, she was able to then mentor her own research teams at the site and received the HIV Vaccine Trial Network (HVTN) mentorship recognition award in 2018.
After ascending to the role of Deputy CEO, Dr. Malahleha founded the Synergy Biomed Research Institute in East London, Eastern Cape, South Africa in 2020. Supported by three directors, the team has grown to 30 multidisciplinary staff who are conducting Phase 3 vaccine trials, an HIV PrEP trial and COVID-19 treatment trials.
To support the planned growth in researchers and research volume, another priority is creating new research centers in non-traditional areas such as Dr. Malahleha’s Synergy Biomed Research Institute (highlighted in the case study above). Well-funded, long-term programs that have invested in research infrastructure and offer training fellowships and mentorship include Developing Excellence in Leadership, Training and Science (DELTAS) Africa program, which aims to produce researchers who can publish and lead high-quality, locally relevant research that will likely have an impact on health policy and practice in Africa. This program was initiated by the Wellcome Trust; is supported by the United Kingdom Department for International Development (DFID), New Partnership for Africa’s Development (NEPAD) and Bill & Melinda Gates Foundation; spanned an initial period of five years (2015-2020); received more than US $100 million in funding; and was controlled and owned by the African Academy of Sciences’ (AAS) Alliance for Accelerating Excellence in Science in Africa (AESA), which is headquartered in Nairobi, Kenya.
During the initial 2015-2020 period, DELTAS Africa supported 11 collaborative teams (e.g., the sub-Saharan African Network for TB/HIV Research Excellence [SANTHE]) spanning 54 institutions across the continent who are committed to the program’s four strategic areas: scientific quality, research training, scientific citizenship and research management and environment. It has been suggested that the success of programs funded by DELTAS Africa have contributed to the success of other current African-led research.3
Other initiatives include the AAS Clinical Trials Community (CTC)
online platform that aims to increase the visibility of investigators and sites in Africa and make country-specific regulatory and ethics procedures more transparent.
Proven, resilient sites and investigators contribute to robust research
The investigators highlighted in these initiatives include internationally recognized key opinion leaders and researchers. Research teams in SSA have proven track records in both recruitment and retention while producing good-quality data. In particular, they’ve navigated challenges that have led to high levels of resilience and therefore operational efficiencies at running clinical trial centers.
In regions lacking sites with suitable infrastructure and systems, research capacity can be successfully developed and used to pursue locally important work, as with the Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL), which was formed during the Ebola outbreak and now conducts studies for Ebola, HIV, COVID-19 and more.
Tapping into the knowledge and experience of local governments, research institutions, sites and investigators is important to ensure the greatest success for a new research program and the resulting capacity.
When evaluating whether to build capacity for a clinical trial, it is important to evaluate whether that capacity will benefit the community and if the resulting intervention (vaccine or treatment) is accessible and affordable for the target communities.
In this example, a study evaluating intermittent preventive treatment of malaria in pregnancy (IPTp) relied on input from the individual countries during trial planning to account for differing circumstances at the international, national and local levels, while complying with global clinical and regulatory standards.4
In addition, through their engagement with stakeholders in the various countries, the study team learned that financial support mechanisms would be required to make the proposed treatment accessible and affordable in the areas of need.
Background
Investigators from 5 countries:
Benin, Kenya, Malawi, Tanzania, Uganda
Trial design was a collaborative effort with input from:
- WHO-GMP
- Malaria in Pregnancy consortium
- International and national regulatory agencies
- University of the Witwatersrand in Johannesburg
- Government departments
- Ministries of health
- Ethics committees
- Local communities
Challenges
Had to consider:
- Current WHO-Global Malaria Program (GMP) malaria treatment guidelines
- Different strains in different countries, including treatment-resistant strains
- Different regulatory and ethics approval processes
Trained Field Workers
- Verified treatment compliance
- Sought participants who missed visits
- Performed postnatal home visits
Financial support was needed to ensure accessible, affordable treatment.
Capitalize on research opportunities in SSA
By investing in researchers and infrastructure to build research capacity in SSA, government and other stakeholders have facilitated high-quality, publishable and globally compliant research. Sponsors can be confident that collaborations with SSA researchers and institutions will yield successful outcomes that will benefit both local and global communities. Interested in learning more about research opportunities in SSA? Check out our other resources, including the recording of our webinar, Africa’s Potential for Clinical Research.
References
- Edem B, Onwuchekwa C, Wariri O, et al. Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries. Trials 2012;22:472. https://doi.org/10.1186/s13063-021-05423-1
- Health Research and Innovation Strategy for Africa (HRISA): 2018-2030. African Union Development Agency (AUDA-NEPAD). Available at: https://www.nepad.org/publication/health-research-and-innovation-strategy-africa-hrisa-2018-2030. Accessed on April 15, 2022.
- Kasprowicz VO, Chopera D, Waddilove KD, et al. African-led health research and capacity building- is it working? BMC Public Health 2020;20:1104. https://doi.org/10.1186/s12889-020-08875-3
- Mtove G, Kimani J, Kisinza W, et al. Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings. Trials 2018;19:190. https://doi.org/10.1186/s13063-018-2563-1
