Strategic Roadmap for Scaling Africa’s Clinical Research Ecosystem

Levi Cheptora

Wed, 05 Nov 2025

I. Executive Summary and Strategic Imperative

The African clinical research ecosystem is currently experiencing rapid evolution, driven by the continent’s immense demographic momentum—with the population potentially doubling by 2050—and the dual public health challenges posed by persistent infectious diseases and the rapid emergence of non-communicable conditions.¹ While this landscape presents a profound opportunity for global health advancement, the continent’s current operational capacity remains profoundly mismatched with its scientific potential and disease burden. To transition the ecosystem from fragmented potential to scalable, globally competitive success, strategic and integrated interventions targeting regulatory efficiency, technological integration, and equitable site partnerships are immediately required.

1.1. Quantifying the Representation and Disease Burden Gap

A fundamental disparity exists between Africa’s disease burden and its inclusion in global scientific discovery. The continent is home to approximately 19% of the world’s population and carries a staggering one-quarter (25%) of the global disease burden.³ Despite this critical need, African countries hosted only between 1.1% and 4% of global clinical trials in 2023.¹

This systemic underrepresentation carries severe scientific and health consequences. The continent contributes less than 2% of the genetic data analyzed in genomics research, leading to crucial gaps in understanding diverse patient populations.¹ The impact of this deficit is evident in cases such as the misdiagnosis and suboptimal treatment for a newly identified, non-autoimmune subtype of diabetes in sub-Saharan Africa, which went unrecognized because local populations were historically underrepresented in Type 1 diabetes clinical research.³ Furthermore, the trials that are conducted often focus exclusively on phases III and IV (comparisons to current standards and long-term effects), limiting the exposure of African researchers and institutions to crucial early-stage research.¹ For diseases highly prevalent in Africa, such as sickle cell disease, which accounts for over 80% of global cases, minimal trial activity for emerging therapies like gene therapy occurs in the region, severely restricting patient access to innovative treatments.⁵

1.2. The Critical Investment Disconnect: Manufacturing vs. R&D

While there has been significant political and financial momentum to strengthen Africa’s health ecosystem, a critical funding imbalance threatens to undermine the long-term sustainability of local research. Since 2020, major commitments totaling $4.02 billion have been tracked for African health R&D.⁶ However, an overwhelming majority of this financial pledge—$3.76 billion, or 80.7%—has been earmarked for manufacturing capacity.⁶ In sharp contrast, clinical trials infrastructure and R&D have received only 1.75% of total commitments, equating to a mere $7 million.⁶

This disproportionate focus on manufacturing risks decoupling product production from local clinical validation and research leadership. Clinical trials serve as a vital gateway to accessing medicines, as pharmaceutical companies typically prioritize market access in countries where trials have been successfully conducted.³ If local R&D capacity is not scaled in parallel with manufacturing capability, the continent risks being relegated to producing products derived solely from foreign research agendas. This compromises the ambition to foster African-defined health solutions and ultimately limits the benefits that local research brings to healthcare systems and economies.⁷ Therefore, scaling success requires ramping up the allocation of domestic resources to clinical research and providing significant incentives for sustained private sector participation in the R&D pipeline.¹

II. Strengthening Collaboration Through Regulatory and Policy Reform

The single greatest structural barrier hindering the expansion of multi-site clinical trials across Africa is the protracted Time to Trial Activation (TTA), a metric that is severely inflated by unharmonized, sequential regulatory review processes. Overcoming this barrier requires a continental regulatory overhaul.

2.1. The Time-to-Activation (TTA) Barrier and the COVID-19 Paradigm Shift

The traditional regulatory pathway in many African nations dictates a sequential review process, which inherently prolongs activation times. In countries such as Kenya, non-COVID-19 clinical trials traditionally required sequential approval from up to four separate entities: the Institutional Scientific and Ethics Review Committee (ISERC), the Pharmacy and Poisons Board (PPB), the National Commission for Science, Technology and Innovation (NACOSTI), and the Ministry of Health (MoH).⁸ This sequential, siloed process often involves substantial duplication of effort and results in a high degree of bureaucratic friction; non-COVID studies routinely required an average of two rounds of back-and-forth responses between the Principal Investigator and the regulatory bodies.⁸ This resulted in a mean TTA for non-COVID-19 studies of 259 days, with approval times ranging from 190 to 399 days.⁸

The urgent demands of the COVID-19 pandemic, however, demonstrated the African system’s latent capacity for rapid, efficient governance. By facilitating parallel processing, reducing unnecessary bureaucratic hurdles, and establishing dedicated staff, mechanisms such as the WHO/African Vaccine Regulatory Forum (AVAREF) Joint Review Pathways allowed entities to review trials simultaneously.⁸ This expedited model dramatically shortened the mean TTA for COVID-related studies to just 80 days (range 40–120 days), proving that infrastructural limitations are often secondary to procedural design and political will.⁸

The significant 179-day difference between the standard and emergency TTA demonstrates that the system possesses the capability to execute rapid, high-quality review without compromising human subject safety or data integrity.⁸ To achieve competitiveness, African sites must apply the lessons learned from the COVID-19 parallel review process to all clinical trials.⁸ Failure to institutionalize this expedited, centralized parallel review actively limits the contribution of African patient data to global knowledge and deters international sponsors seeking rapid site activation.⁸

Comparison of Regulatory Pathways and Time-to-Trial Activation (TTA) in Kenya

2.2. Harnessing Regional Harmonization (AMA and AMRH)

The sustained effort toward regulatory harmonization is pivotal for scaling multi-country trials. The African Medicines Regulatory Harmonization (AMRH) program, initiated in 2009 by the AUDA-NEPAD, sought to address inconsistent legislative frameworks, limited technical capacity, and sluggish approval processes among National Medicine Regulatory Authorities (NMRAs).¹⁰

A critical milestone in this journey is the imminent establishment of the African Medicines Agency (AMA), which will coordinate and strengthen various harmonization initiatives.³ The AMA is intended to act as a facilitator, pooling resources and working with NMRAs and Regional Economic Communities (RECs) to avoid duplication of work and ensure consistent oversight of clinical trials and pharmacovigilance across the continent.¹² Precursor platforms, such as the African Vaccine Regulatory Forum (AVAREF), have already demonstrated success by streamlining national regulatory and ethics reviews through joint assessments of vaccine clinical trial applications across multiple African countries.³

Regulatory maturity driven by harmonization is an economic driver, not merely a bureaucratic improvement. By reducing TTA and providing consistent, standardized oversight across numerous countries, the AMA effectively transforms Africa from a collection of 54 small, high-friction markets into a competitive, large-scale research bloc. This strategic consolidation directly addresses industry priorities by accelerating participant recruitment and shortening pathways to market entry.³ To fully support this shift, African governments must implement policy requirements, including overhauling national health infrastructure, focusing on robust data systems and resilient supply chains, and generating clearer clinical guidelines.¹

III. Scaling Success with Smarter Tools and Digital Health Technology

The adoption of smarter digital tools, coupled with reliable health infrastructure, is essential for improving operational efficiency, maintaining data quality, and expanding the geographic reach of clinical trials across Africa.

3.1. The Operational Imperative of Digital Health Infrastructure

Foundational infrastructure, particularly in data management, is critical for achieving scale. Interoperable Electronic Health Records (EHRs) promote greater efficiency by enabling healthcare professionals to focus on high-value tasks, reducing the necessity for duplicative tests.¹³ While EHRs have seen adoption within targeted disease programs, such as those for HIV and tuberculosis, holistic, widespread interoperability across health systems remains limited.¹³

The effective use of Artificial Intelligence (AI) and Machine Learning (ML) algorithms represents a significant opportunity. These tools can analyze large volumes of patient data to identify patterns, predict disease progression, support accurate diagnoses, and facilitate personalized care recommendations.¹⁴ For example, AI/ML holds immense promise for transforming diagnostics and disease control, such as digital solutions for malaria in resource-constrained settings.¹⁵

However, the effective deployment of these sophisticated tools requires foundational investment in high-quality, standardized input data. The current deficit in holistic, interoperable EHRs ¹³ and a general lack of open databases and software ¹⁶ means that African research risks being constrained to small-scale, siloed studies. Scaling research mandates major foundational investment in GCLP-standard data management services and adherence to FAIR data principles (Findable, Accessible, Interoperable, Reusable).¹⁷

3.2. The Role and Challenges of Decentralized Clinical Trials (DCTs)

Decentralized Clinical Trials (DCTs), which leverage remote data collection technologies and telemedicine, represent a patient-centric model designed to overcome logistical barriers associated with traditional site-based trials, thus improving patient-centricity and the generalizability of findings.¹⁸ This flexibility is particularly advantageous for expanding clinical trial access in Africa’s vast and geographically diverse regions.

However, the implementation of DCTs faces significant practical challenges in the sub-Saharan African context.²⁰ These include:

1. Digital Literacy Gaps: A lack of patient and provider familiarity with telemedicine and digital health tools affects adoption rates, necessitating substantial investment in digital education and training.²⁰
2. Data Quality and Technology: Concerns about maintaining data quality and regulatory compliance during remote data collection are paramount among study teams.²²
3. Regulatory and Ethical Hurdles: The transformation from a site-centric to a patient-centric model demands new frameworks to address ethical and regulatory issues, including data protection, licensing, and accountability.²⁰

3.3. Ensuring Ethical and Regulatory Oversight of Digital Tools

To ensure the long-term sustainability of DCTs and digital transformation, policy reforms are essential. National telemedicine policies must be developed to include clear reimbursement structures, licensing regulations, and robust data protection laws.²¹ South Africa’s existing regulatory framework serves as an important model that other African nations, such as Nigeria and Kenya, can adapt.²¹

Furthermore, regulatory guidance must proactively govern innovation. South Africa's Health Products Regulatory Authority (SAHPRA) is actively developing guidance documents for Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices, aiming to harmonize with global trends while addressing the specific requirements of South Africa’s unique healthcare and data governance context.²³ Ethically, the National Health Research Ethics Council (NHREC) Ethics Guidelines provide a framework for AI application, specifically focusing on transparency, fairness, and accountability.²⁴ Without clear governance on issues such as data ownership, algorithmic bias, and security, large-scale digital tool adoption risks exacerbating existing health inequities or compromising participant trust.

IV. Efficient Site Partnerships and Capacity Transformation

Scaling research across Africa requires moving beyond transactional interactions toward efficient, reciprocal, and equitable partnerships that actively address historical power imbalances and embed sustainable, African-led research capacity.

4.1. Defining Equitable and Transformational Partnerships

For decades, significant resource disparities between international sponsors and African sites have occasionally led to exploitative practices.¹⁶ Building mutual trust and respect requires long-term engagement, transparency in budgeting, project planning, and all steps of the research process.²⁵ Successful, scalable partnerships can be conceptualized across three levels—transactional, collaborative, and transformational—where equity and sustainability form the foundation of the highest level.²⁶

Funders and sponsors hold a pivotal responsibility in actively counteracting power imbalances. This is best achieved by explicitly assigning leadership roles and directing primary funding to the local African institutions where the research is conducted.²⁵ Key partnership components include reciprocity in learning, such as joint degrees or twinning programs for researchers, and ensuring research findings are rapidly translated into policy and clinical practice in the local context.²⁵

Strategic Matrix for Equitable Site Partnerships

4.2. Models for Embedded Capacity Enhancement

Capacity building is most effective when integrated into functional, multicountry networks and consortia, which act as force multipliers for overcoming logistical barriers.³ Examples of successful models include the East African Consortium for Clinical Research (EACCR) ²⁹ and the Clinical Trials Community Africa Network (CTCAN).³⁰ CTCAN aims to develop an umbrella sub-Saharan African network, supplementing it with epidemiological data and regulatory information, and crucially, building capacity for Stringent Regulatory Authority (SRA)-quality trials.³⁰

A concrete example of integrated research and capacity building is the PAMAfrica consortium. This initiative conducts large-scale clinical trials for antimalarial therapies, including treatments for infants and severe malaria, while dedicating an entire work package to training and capacity development. This includes enhancing research capacity at trial sites and providing technical training and academic scholarships to 11 next-generation African scientists from partnering institutions.²⁸ Furthermore, long-term, multi-million dollar programmes like DELTAS Africa support consortia led directly by African scientists, which is vital for ensuring that research priorities are defined locally and are sustainable.³²

4.3. Addressing Core Infrastructural and Human Resource Deficits

Significant infrastructural hurdles persist across the continent, with many potential research sites lacking the institutional review mechanisms and robust research infrastructure required for large-scale trials.³³ Effective capacity enhancement models must address these deficits holistically, focusing on operational rigor, including:

1. Rigorous Oversight: Implementing rigorous scientific and operational review of all proposals, coupled with strong grants management and financial accountability.²⁷
2. Training and Compliance: Establishing a clinical research training unit that offers regular training in GCP and regulatory compliance, alongside providing internal monitoring and regulatory coordination.²⁷
3. Workforce Strategy: Bolstering the public health workforce is a critical enabler, involving the enhancement of leadership capabilities, refinement of technical competencies, and high-level advocacy for workforce development, as driven by the Africa CDC's strategic plan.³⁴

V. Strategic Synthesis and Future Outlook

Scaling success in Africa requires the simultaneous mobilization of policy, technology, and partnership actions. Fragmented efforts that address only one pillar risk creating new bottlenecks. For instance, investing heavily in decentralized clinical trial (DCT) technology ²⁰ will fail unless paralleled by regulatory reform (AMA harmonization, AI/ML policies ¹²) and the partnership commitment to fund digital literacy training for users and participants.²¹

5.1. The Integrated Roadmap for Scaling Success

The immediate strategic priority for international sponsors, regional bodies (AMA/AUDA-NEPAD), and governments must be the institutionalization of the parallel/expedited review model proven successful during the COVID-19 pandemic. Applying this efficient process universally is the clearest path to driving down the mean Time to Trial Activation (TTA) below the 100-day mark, thereby making African sites globally competitive for multi-center studies.⁸

5.2. Recommendations for International Sponsors and Donors

To ensure that the African research ecosystem achieves resilience and equity, specific actions are necessary:

• Rebalance R&D Investment: International funders must urgently address the critical funding imbalance by directing a substantially greater proportion of R&D commitments toward clinical trials infrastructure and research capacity building, mitigating the disproportionate historical focus on manufacturing.⁶
• Broaden Therapeutic Scope: While infectious disease research is vital, sponsors must expand trial activity into non-communicable diseases (NCDs) and under-represented conditions, such as diabetes, sickle cell disease, and oncology.³ This expansion is necessary to reflect the continent’s true burden of disease and address critical gaps in genetic diversity data.
• Adopt Transformational Partnership Models: Sponsors should definitively move toward models where African scientists lead consortia (e.g., DELTAS and PAMAfrica models) ³¹ and where primary funding is directed to local African institutions. This counteracts resource disparity and ensures long-term sustainability and ownership of the research agenda.²⁵

5.3. Conclusion: Fostering an African-Led Research Agenda

The structural transformation of Africa’s clinical research ecosystem requires a paradigm shift from being a passive trial recipient to an active research leader. This necessary transformation hinges on political will to achieve robust regulatory harmonization via the African Medicines Agency, sustained financial commitment to self-sustaining local capacity building, and the strategic adoption of smarter technologies governed by clear, context-adapted ethical frameworks. By integrating these three pillars—stronger collaboration, smarter tools, and efficient partnerships—Africa can achieve a resilient, inclusive, and continentally-relevant clinical research environment, ultimately ensuring that its massive and diverse patient population benefits fully from global scientific advances.

Works cited

1. How scaling up clinical research in Africa can benefit society and the economy, accessed November 4, 2025, https://www.weforum.org/stories/2024/08/africa-scaling-up-clinical-research-benefit-society-economy/
2. How scaling up clinical research in Africa can benefit society and the economy, accessed November 4, 2025, https://www.gavi.org/vaccineswork/how-scaling-clinical-research-africa-can-benefit-society-and-economy
3. Harnessing Africa's untapped clinical trial potential - Access to Medicine Foundation, accessed November 4, 2025, https://accesstomedicinefoundation.org/access-insights/harnessing-africas-untapped-clinical-trial-potential
4. Strengthening clinical research capacity and enhancing clinical trial coordination in Africa, accessed November 4, 2025, https://scienceforafrica.foundation/media-center/strengthening-clinical-research-capacity-and-enhancing-clinical-trial-coordination
5. Improving access to innovative medicines in Africa starts with clinical trials, accessed November 4, 2025, https://www.gavi.org/vaccineswork/improving-access-innovative-medicines-africa-starts-clinical-trials
6. Strengthening Africa's health R&D and manufacturing ecosystem: Analysis of the investments and gaps | PATH, accessed November 4, 2025, https://www.path.org/our-impact/articles/strengthening-africas-health-rd-and-manufacturing-ecosystem-analysis-of-the-investments-and-gaps/
7. Africa Research Excellence Fund: Home, accessed November 4, 2025, https://africaresearchexcellencefund.org.uk/
8. Regulatory approval of clinical trials: is it time to reinvent the wheel ..., accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC10823920/
9. accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC10823920/#:~:text=Mean%20TTA%20for%20COVID%2Drelated,of%20clinical%20trials%20in%20Africa.
10. AMRH Home | AUDA-NEPAD- AMRH, accessed November 4, 2025, https://amrh.nepad.org/
11. African Medicines Regulatory Harmonisation (AMRH) - AUDA-NEPAD, accessed November 4, 2025, https://www.nepad.org/programme-details/998
12. The African Medicines Agency: Impacts on the Continent's Clinical Trials Regulation, accessed November 4, 2025, https://www.appliedclinicaltrialsonline.com/view/the-african-medicines-agency-impacts-on-the-continent-s-clinical-trials-regulation
13. Digital tools could boost efficiency in African health systems | McKinsey, accessed November 4, 2025, https://www.mckinsey.com/industries/healthcare/our-insights/how-digital-tools-could-boost-efficiency-in-african-health-systems
14. Transforming African Healthcare with AI: Paving the Way for Improved Health Outcomes, accessed November 4, 2025, https://www.jscimedcentral.com/jounal-article-info/Journal-of-Collaborative-Healthcare-and-Translational-Medicine/Transforming-African-Healthcare-with-AI:-Paving-the-Way-for-Improved-Health-Outcomes-11760
15. AI Healthcare Research Laboratory - CMU-Africa, accessed November 4, 2025, https://www.africa.engineering.cmu.edu/research/ai-healthcare.html
16. Ten simple rules for successful and sustainable African research collaborations - PMC - NIH, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11210762/
17. Global collaborative action for strengthening the Regional Networks of Excellence and Epidemic Preparedness Consortia - ERRIN, accessed November 4, 2025, https://errin.eu/calls/global-collaborative-action-strengthening-regional-networks-excellence-and-epidemic
18. Decentralized Clinical Trials (DCT) - Oracle, accessed November 4, 2025, https://www.oracle.com/life-sciences/clinical-trials/decentralized-clinical-trials/
19. Decentralized Clinical Trials in the Era of Real‐World Evidence: A Critical Assessment of Recent Experiences - PubMed Central, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC12416308/
20. Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study - PubMed Central, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC10533674/
21. Telemedicine Adoption and Prospects in Sub-Sahara Africa: A Systematic Review with a Focus on South Africa, Kenya, and Nigeria - PMC - PubMed Central, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11989057/
22. Decentralized Clinical Trials (DCT) | Oracle Africa Region, accessed November 4, 2025, https://www.oracle.com/africa/life-sciences/clinical-trials/decentralized-clinical-trials/
23. REGULATORY REQUIREMENTS OF ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING (AI/ML) ENABLED MEDICAL DEVICES - SAHPRA, accessed November 4, 2025, https://www.sahpra.org.za/wp-content/uploads/2025/09/MD08-20252026_-SAHPRA-Communication-to-Industry-AI-Medical-devices_Acknowledgements.pdf
24. Overview of AI regulation in healthcare: A comparative study of the EU and South Africa, accessed November 4, 2025, https://journals.co.za/doi/10.7196/SAJBL.2024.v17i3.2294
25. Towards equitable partnerships in global health research: experiences from Ethiopia, Uganda, Lao PDR and Vietnam, accessed November 4, 2025, https://gh.bmj.com/content/10/6/e019130
26. Towards equitable partnerships in global health research: experiences from Ethiopia, Uganda, Lao PDR and Vietnam - PubMed Central, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC12211826/
27. Developing independent investigators for clinical research relevant for Africa - PMC, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC3283488/
28. Equitable partnerships with malaria-endemic countries, accessed November 4, 2025, https://www.mmv.org/partnering-opportunities/equitable-partnerships
29. Home • East African Consortium for Clinical Research - The Global Health Network, accessed November 4, 2025, https://eaccr.tghn.org/
30. Clinical Trial Community Africa Network: Home, accessed November 4, 2025, https://www.ctcan.africa/
31. Portfolio approach to developing the next generation of malaria treatments for Africa (PAMAfrica) - MESA, accessed November 4, 2025, https://mesamalaria.org/mesa-track/portfolio-approach-developing-next-generation-malaria-treatments-africa-pamafrica/
32. DELTAS Africa: A hub and spoke model of funding research | Science for Africa Foundation, accessed November 4, 2025, https://scienceforafrica.foundation/media-center/deltas-africa-hub-and-spoke-model-funding-research
33. Clinical research in Africa And Middle East: roadmap for reform and harmonisation of the regulatory framework and sustainable capacity development - Journal of Global Health Reports, accessed November 4, 2025, https://www.joghr.org/article/12124-clinical-research-in-africa-and-middle-east-roadmap-for-reform-and-harmonisation-of-the-regulatory-framework-and-sustainable-capacity-development
34. Charting a healthier future: Africa CDC's strategic approach towards strengthening the health workforce of the African continent - PubMed Central, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC10662212/
35. Africa CDC and Global Health EDCTP3 sign Memorandum of Understanding to promote public health in Africa, accessed November 4, 2025, https://africacdc.org/news-item/africa-cdc-and-global-health-edctp3-sign-memorandum-of-understanding-to-promote-public-health-in-africa/
36. Patterns of Oncological Clinical Trials in African Countries: A Scoping Review - PMC, accessed November 4, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC12527969/