Controlled Clinical Trials in Sub-Saharan Africa: A Winning Value Proposition

The conduct of controlled clinical trials in traditional settings is faced with many challenges often resulting in important delays in the execution of studies. In most geographic settings, there is a limited pool of eligible patients because of small catchment areas and competition for participation in other studies. Many studies are faced with slow recruitment because eligibility criteria have increased and trials become more complex. In a metanalysis of clinical trials in the UK less than 56% of clinical trials reached the target sample size.¹ Another metanalysis of clinical trials in chronic disease found a pooled dropout rate of 43%.² And lastly, a metanalysis of 2,542 randomized clinical trials showed that around one out of five studies completes within the planned timeframe, and that the median delay in completion is 12.2 months.³

Africa remains underrepresented in global clinical research

According to estimates, only 1.1% of clinical trials are being conducted in Africa.⁴ This lack of interest in considering this region for the roll-out of clinical trials is rooted in lack of knowledge and misconceptions about what can be done.

In the past two decades, funding by development agencies has resulted in the building of important capacity and capabilities in the execution of controlled clinical trials, predominantly focused on infectious diseases, including HIV/AIDS, tuberculosis, COVID-19, and Human Papilloma Virus infection. The capacity covers a wide-range of drug and vaccine trials, studies on the accuracy of diagnostic tests, and efficacy and effectiveness of medical devices. A comprehensive database has identified around 5,000 potential clinical research sites throughout Africa.⁵

Declining donor funding leaves untapped research capacity

The funding of donor-funded clinical research activities in sub-Saharan Africa has recently declined because of the discontinuation of development aid through several bilateral and multilateral programs. This frees up a large, untapped potential of highly qualified medical professionals trained in Good Clinical Practices (GCP) and working according to Standard Operating Procedures (SOPs) and policies, and infrastructure related to networks of dedicated clinical research sites, laboratories, and medical equipment. The catchment area of the clinical research sites includes many millions of patients representing an extensive pool of potential study participants.

Rising burden of non-communicable diseases expands trial potential

Sub-Saharan Africa offers an excellent opportunity in conducting clinical research in non-communicable diseases due to demographic shifts to ageing populations, increasing adoption of unhealthy Western lifestyles (smoking, substance abuse, fast food consumption, lack of physical exercise), genetic predisposition, and environmental factors (biomass smoke exposure):

• The pooled prevalence of Chronic Obstructive Pulmonary Disease (COPD) in sub-Saharan Africa is 8% with a variance between 1.7 and 24.8% depending on geographical and socio-demographic factors.⁶
• More than 30% of adults have high blood pressure, but most cases are undiagnosed and of those only a small portion are treated with antihypertensive medication.⁷ As a consequence, the incidence of different manifestations of ischemic heart disease is increasing.
• The age-related prevalence of diabetes is currently relatively low with 5% or 25 million adults living with type 2 diabetes but is expected to increase in the next 25 years to 60 million, while overweight and obesity-related pre-diabetes is currently estimated as 95 million reaching 223 million by 2050.⁸
• The incidence of breast cancer in sub-Saharan Africa is reported to be close to 200,000 annually, roughly 8% of worldwide incidence. The cancer-associated mortality is disproportionally high at 15%, reflecting the lack of treatment access.⁹

Genetic diversity strengthens oncology and precision medicine research

The population of Africa has the greatest diversity of genetic variation in the world. Our species arose in Africa about 150,000 years ago, while in the last 30 to 40,000 years small groups of humans with limited genetic variation migrated to, and settled in, the rest of the world, resulting in declines of genetic diversity in the ancestors of Europeans, Asians, and others.¹⁰ A genetically diverse study population in clinical trials is of critical importance to understand the efficacy and effectiveness of study medication in oncology trials.

What does Africa have to offer:

• Networks of experienced clinical trials sites with motivated principal investigators and research staff.
• An extensive pool of eligible trial-naïve patients without significant trial competition in a large range of therapeutic areas.
• Access to genetically diverse treatment groups.
• Fast recruitment of study participants, high consent and retention rates, and diligent collection of complete data sets.

Real-world site performance demonstrates high consent and retention

The newly created NewCo-X, for example, with its coordination center in Johannesburg concentrates on clinical research in non-communicable diseases and is built on the extensive clinical trial experience of Ezintsha which has been involved for over 13 years in donor-funded clinical research, performing more than 34 controlled clinical trials, and enrolling nearly 10,000 trial participants.¹¹ Resources include more than 120 staff members dedicated to coordinating clinical research across a growing network of sites in sub-Saharan Africa. NewCo-X is particularly strong in community outreach, and creating enabling conditions for trial participation.The estimated catchment area is close to 16 million people. The informed consent rate is above 80% and the retention rate of trial participants varies between 85 and 96%.

What are possible hurdles:

• Limited usage of electronic health records and dependence on manual data entry.
• Some countries have under resourced regulatory agencies resulting in slow approval times. This is being addressed by the creation of the African Medicines Agency (AMA) ratified by 29 countries.¹²
• Few sites have access to pharmaco-genomics, and access to advanced imaging techniques (MRI, CT scan, PET scan) is limited as well.
• There exists an ethical requirement to continue the provision of test and/or complementary medication once a participant has completed a study and until the availability of a generic version of the drug(s).

The current practice of financing clinical research is based on the payment of costs incurred in trial execution, and is not associated to the performance of the clinical research site. As a result, historically, sites in African countries are paid much less compared to studies conducted elsewhere, regardless of the excellence in study performance. It is estimated that the value of a single day of delay in a clinical trial costs the sponsor approximately $500,000 in unrealized prescription drug sales and $40,000 in direct daily clinical trial costs.¹³ We argue that the payment of clinical studies should be based on fair market value such that those who execute most effectively are paid commensurably. This will allow African sites to address the shortcomings and develop their diagnostic, digital health, and clinical research capacity.

Outlook: Faster trials, economic value, and broader access

Weighing the pros and cons, the overall outlook of including site networks located in sub-Saharan Africa for contract research organizations (CROs) and innovative pharmaceutical companies is positive. The inclusion of African site networks has the potential to accelerate significantly the execution of clinical trials with rapid identification of eligible study participants, high informed consent rates, and a low number of dropouts. As time is precious, it would result in significant economic benefits in drug development and commercialization.Additionally, it would be an important contribution to African societies in terms of expanded access to health care products, strengthened clinical research and regulatory capacity, local guidelines development, improved understanding of treatment performance in underrepresented populations, and would facilitate market access to an emerging middle class with the willingness and capacity to pay for health care.¹⁴

Donald de Korte, Alan Boyce, and Karin Kanewske Turner (HALO Research Technology)

References

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4. https://accesstomedicinefoundation.org/access-insights/harnessing-africas-untapped-clinical-trial-potential
5. https://www.ctcan.africa/
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8. International Diabetes Federation: 11^th Edition Diabetes Atlas 2025; 74-75.
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11. https://www.ezintsha.org/
12. https://www.nepad.org/microsite/african-medicines-agency-ama
13. Getz K How Much Does a Day of Delay in a Clinical Trial Really Cost? Applied Clinical Trials – 06-01-2024; 33(6).
14. https://accesstomedicinefoundation.org/access-insights/harnessing-africas-untapped-clinical-trial-potential