Figure 1. Number of clinical trials by year, country, WHO region and income group (1999-2022). Source: World Health Organisation (February 2023).
The global landscape of clinical research (CR) has experienced substantial growth, with thousands of clinical trials (CTs) conducted annually. Yet, Africa, despite its vast potential, remains an underutilised region in this global research effort. A closer look reveals that scaling up CTs in Africa could yield significant benefits for both the continent and the world at large, especially as the demand for diverse research populations continues to grow.
Africa’s Current Role in Clinical Trials
Globally, the number of CTs has surged over the past decade. These trials are essential for evaluating new medical treatments, understanding diseases, and improving public health outcomes. Traditionally, a majority of these trials have been concentrated in regions like North America, Europe, and parts of Asia. However, this model leaves a critical gap in the data, as populations in underrepresented regions, including Africa, often do not participate in research that ultimately impacts their healthcare.
Africa’s limited involvement in global CTs is particularly striking given its vast and diverse population. Africa is recognised as the fastest growing region in the world, with projections indicating that more than half of global population growth between now and 2050 will occur on the continent. Sub-Saharan Africa’s population is expected to double, reaching approximately 2.5 billion people. While the continent has made significant progress in managing infectious diseases, the increasing prevalence of non-communicable diseases (NCDs), combined with the looming threat of new pandemics, places even greater pressure on already burdened healthcare systems. These challenges complicate efforts to meet broader developmental goals and underscore the need for more robust CR initiatives.
Data from the World Health Organisation (WHO) demonstrates that out of the 78,285 clinical trials conducted worldwide in 2021, only 1,078 were initiated in African countries, with 25,634 hosted by countries in the Western Pacific Region. Figure 1 (above) illustrates this stark contrast that must be addressed to ensure Africa is an integral part of the global health research community.
Why Africa Matters for Clinical Research
Africa’s inclusion in CTs is vital for ensuring that medical treatments are safe and effective for all populations. The continent’s unique genetic, environmental, and cultural diversity makes it an ideal setting for studying how different treatments perform across various groups.
One of the most compelling reasons for expanding CTs in Africa is the need for balanced representation. People from different demographic and healthcare backgrounds must participate in clinical trials to ensure that medicines are both effective and safe for their intended populations. Without this diverse representation, the pharmaceutical and healthcare industries face challenges in fully understanding how diseases affect different groups and how likely drugs are to work across populations. This is particularly important for populations that have often been overlooked in research, making Africa’s involvement crucial for filling these gaps in global healthcare.
CTs conducted in Africa can enhance the global understanding of diseases that disproportionately impact the region, such as malaria, HIV, and tuberculosis. But beyond infectious diseases, Africa’s participation in trials focused on chronic conditions like diabetes, hypertension, and cardiovascular disease can provide critical insights that benefit people globally.
Moreover, CTs in Africa can help tailor treatments to specific genetic profiles. For example, some medications may work differently in African populations due to genetic variations that are less common elsewhere. Understanding these differences through well-structured trials can lead to more personalised treatments for African patients, including members of the African diaspora living in other regions. This not only ensures that drugs developed globally are more inclusive but also supports a more equitable approach to healthcare.
The Economic Benefits
Expanding CTs in Africa offers significant economic and social opportunities. Beyond improving health outcomes, increasing CR capacity can stimulate job creation, boost healthcare infrastructure, and drive innovation across the continent. With a population expected to double, the continent represents a significant market for biopharmaceutical innovations, particularly for diseases that disproportionately affect the region. This makes Africa an attractive location not only for its genetic diversity but also for its market potential, where pharmaceutical companies can tap into a growing consumer base.
Developing CR infrastructure will also foster collaborations between African health institutions and global research organisations, further positioning Africa as a key player in health sciences. These partnerships could lead to increased foreign investments in both healthcare and broader economic sectors, as global companies recognise the potential for research and development in Africa.
Good Clinical Practice in Africa
Good Clinical Practice (GCP) is becoming increasingly integrated into the regulatory frameworks of African countries, as more nations align with international CT standards by incorporating ICH/GCP guidelines into their approval processes for regulatory and ethics committees, ensuring that clinical trials meet global quality standards. This shift is vital in improving the continent’s capacity to conduct high-quality, ethical research that benefits local populations and contributes to global health solutions.
Kenya serves as an excellent example of this progress. The country has made significant strides in clinical trials due to its efficient regulatory systems, strong political commitment, and targeted funding. Kenya’s success demonstrates how robust regulatory frameworks can accelerate clinical research, setting an example for other African nations like South Africa, Egypt, Morocco, and Tunisia, where similar advancements are taking place.
At Pharmalys, we are committed to supporting the growth of GCP and Good Clinical Laboratory Practice (GCLP) across the continent. Our organisation is fully certified to conduct GCP-compliant research across the world. In addition to expanding our international and regional networks, we focus on capacity building initiatives through specialised training for Ethics Committees and regulatory bodies. These trainings are designed to enhance the skills of key stakeholders, ensuring the highest ethical and regulatory standards are maintained across the continent.
Pharmalys’ creation of PACE (Pharmalys Academy of Clinical research Excellence) further supports the sector by producing job-ready professionals. Through a curriculum aligned with international CR standards, PACE equips graduates with the knowledge needed to succeed in the global CR environment.
Through our continued efforts, Pharmalys aims to strengthen the CR ecosystem in Africa, contributing to high-quality health research and fostering sustainable development in the sector. Read more: https://www.pharmalys.com/capacity-building/ ; https://pace-cr.com/
Breaking Down Barriers
To fully acknowledge the benefits of increased CTs in Africa, several long-standing challenges must be addressed. Historically, the continent has faced reluctance from sponsors due to concerns over limited infrastructure, a shortage of skilled professionals, insufficient funding, and bureaucratic hurdles. However, there is growing momentum to overcome these obstacles. African governments, healthcare institutions, and international organisations are increasingly investing in research capacity by streamlining regulatory processes, enhancing local expertise, and providing funding for education and training. As highlighted in an article by The Clinical Trial Vanguard, a supportive political environment is crucial for fostering a culture of research and innovation. Offering incentives for research and development, establishing international research partnerships, and promoting local research capabilities can significantly alter investor perceptions.
In addition, Africa’s involvement in trials during the COVID-19 pandemic demonstrated the continent’s growing capacity for conducting high-quality research. Participation in global vaccine trials showcased that, with the right investment and infrastructure, Africa can play a significant role in advancing groundbreaking global health initiatives.
A Future Built on Research
For the continent to fully implement its potential within the CR space, it is crucial that efforts to increase the number of trials continue. The inclusion of African populations in CTs is not only a matter of global health equity but also essential for ensuring that medical treatments are effective across all demographics. As we move forward, Africa’s role in CTs will be key in shaping the future of medicine, benefiting not only the continent but the global population.
By building research capacity in Africa, fostering partnerships, and encouraging investment in local infrastructure, we can pave the way for a healthier, more inclusive world.
Marieme Ba,
CEO of Pharmalys Ltd and PACE Ltd
