Africa carries a substantial share of the global disease burden but continues to host only a small proportion of global clinical trials (1). This imbalance affects where evidence is generated, whose populations are represented, and how confidently findings can be applied across settings.
Where the Continent Stands Today
Africa’s current position in the global life sciences value chain is defined by uneven participation. Clinical research activity is concentrated in a limited number of countries, with significant variation in infrastructure, regulatory capacity, and workforce readiness across the continent (2). While there has been steady growth in research sites, ethics review systems, and supporting infrastructure, scale and consistency remain limiting factors.
Regulatory processes still differ substantially across jurisdictions, often leading to variable approval timelines, requirements, and expectations for study sponsors (3). This fragmentation creates operational complexity for multi-country research and reduces the continent’s attractiveness for larger coordinated studies. At the same time, many therapies used in African health systems are approved based on data generated outside the continent. This raises questions about how well those findings translate to populations with different genetic profiles, disease patterns, and health system conditions.
There are, however, clear signs of progress. Regional efforts to harmonize regulatory systems, including the establishment of the African Medicines Agency, signal movement toward more coordinated governance (4). Investment in research networks and site development has also increased through a mix of public, philanthropic, and private partnerships. These developments suggest that the current constraints are not fixed, but structural.
Why This Matters for Africa and for Global Health
The implications of this imbalance extend beyond representation. They affect the reliability and applicability of scientific evidence.
For African health systems, limited participation in clinical research can contribute to slower access to new therapies and a weaker base of context-specific implementation evidence (5). That leaves health systems adapting tools and interventions without enough data on how they perform under local conditions.
For global stakeholders, the consequences are equally substantive. Clinical datasets that do not adequately reflect population diversity can limit understanding of how treatments perform across different groups (6). This is particularly relevant for conditions where genetic, environmental, or co-morbidity factors influence outcomes. Expanding the geographic distribution of trials is therefore not only a matter of inclusion but of scientific rigor.
This is not only a question of visibility. It is a question of whether the global evidence base is sufficiently robust, transferable, and useful across populations and health-system conditions.
What Better Research Systems Can Change
When clinical research is embedded effectively within health systems, it does more than generate efficacy data. It helps shape how interventions are delivered, adapted, and sustained in practice.
In African contexts, stronger research systems enable study designs that better reflect real-world conditions. Local investigators and site teams contribute practical insights into patient recruitment, retention, and adherence, improving both feasibility and data quality. Trials conducted within or alongside routine care settings can also generate operational evidence about supply chains, staffing, patient pathways, and service delivery (7).
This type of evidence is essential for translating research into practice. It informs not only whether an intervention works, but how it can be delivered at scale. Consistent adherence to international quality standards further strengthens regulatory confidence and supports the inclusion of African sites in more complex and higher-value studies. Evidence from multi-country clinical-research capacity-building initiatives suggests that, when appropriately supported, African sites can achieve high standards of data quality and protocol adherence comparable to global expectations (7).
At the same time, locally generated data plays a critical role in national decision-making. It supports policy development, guides resource allocation, and strengthens the case for adopting and scaling effective interventions.
What Needs to Happen Next
A different outcome over the next decade will depend on coordinated changes across systems, not isolated interventions. Regulatory alignment remains central. Continued progress toward more harmonized and predictable approval processes would reduce duplication and make multi-country research more feasible.
Investment in site systems must also shift from short-term project support to longer-term capacity building. Laboratories, data systems, and quality management processes require ongoing support if they are to perform consistently and meet international expectations over time.
Workforce development is closely tied to this. Training alone will not be enough without clear career pathways, competitive compensation, and practical mechanisms for retaining skilled professionals within the research ecosystem.
Integration with health systems is equally important. Research that is embedded within routine service delivery generates evidence that is directly applicable to real-world conditions. This approach strengthens both the research process and the health system itself, creating a feedback loop between evidence generation and implementation.
Partnership models will also need to evolve. Collaborative models that include African institutions in study design, governance, implementation, and data analysis improve both relevance and execution. This is not only a question of ownership. It is also a question of scientific quality and long-term system strength.
Finally, investment in digital infrastructure and interoperable data systems will be important for multi-country research, better evidence generation, and more effective use of data for policy, planning, and regulatory confidence.
Conclusion
Ten years from now, success should be visible not in isolated examples of excellence, but in systems that function more predictably across the continent. Africa would be included more routinely in global clinical development, supported by clearer regulatory pathways, stronger site networks, durable workforce capacity, and more consistent research governance.
Evidence generated on the continent would inform both local and global decision-making, helping shape interventions that are more applicable, more scalable, and more responsive to real health-system conditions.
This outcome is achievable, but only if current gains are extended, standardized, and connected into a more coherent system. The question is no longer whether progress is possible. It is whether governments, institutions, funders, and partners will make the decisions now that allow that future to take shape.
That is what success should look like: not visibility alone, but lasting scientific and public-health value.
References
- Solarin O, Mohammed SI, Ndlovu N, Vanderpuye V, Olaiya V. Partnerships and Collaborations: The Right Alliances for Clinical Trials in Africa. JCO Glob Oncol. 2020 Jul 2;6:JGO.19.00194. doi:10.1200/JGO.19.00194 PubMed PMID: 32614730; PubMed Central PMCID: PMC7392723.
- Yilma D. Breaking the barriers for conducting clinical trials in Africa: A need for higher commitment and collaborations. Ethiop J Health Sci. 2024 May;34(3):171–2. doi:10.4314/ejhs.v34i3.1 PubMed PMID: 40438443; PubMed Central PMCID: PMC12110202.
- Sithole T, Mahlangu G, Capote V,SitoieT, Shifotoka S, Gaeseb J, et al. Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front Med. 2021 Aug 27;8:742200. doi:10.3389/fmed.2021.742200 PubMed PMID: 34513894; PubMed Central PMCID: PMC8429484.
- Ncube BM, Dube A, Ward K. Establishment of the African Medicines Agency: progress,challengesand regulatory readiness. J Pharm Policy Pract. 2021 Mar 8;14(1):29. doi:10.1186/s40545-020-00281-9 PubMed PMID: 33685518; PubMed Central PMCID: PMC7938385.
- Harnessing Africa’s untapped clinical trial potential | Access to Medicine [Internet]. [cited 2026 Apr 22]. Available from: https://accesstomedicinefoundation.org/insights-resources/access-insights/harnessing-africas-untapped-clinical-trial-potential
- National Academies of Sciences E, Affairs P and G, Committee on Women in Science E, Research C on I the R of W and UM in CT and, Bibbins-Domingo K, Helman A. Why Diverse Representation in Clinical Research Matters and the Current State of Representation within the Clinical Research Ecosystem. In: Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups [Internet]. National Academies Press (US); 2022 [cited 2026 Apr 22]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK584396/
- Ndembi N, Mekonen TT, Folayan MO, Dereje N, Kruger A, Fokam J, et al. Strengthening and expanding capacities in clinical trials: advancing pandemic prevention,preparednessand response in Africa. Nat Commun. 2024 Oct 7;15(1):8662. doi:10.1038/s41467-024-53126-3