The Persistent Challenge of Underrepresentation

Africa shoulders approximately 25% of the world's disease burden, yet its populations remain strikingly underrepresented in major clinical trials that inform global medical guidelines. A comprehensive analysis published in early 2026 in the Journal of the American College of Cardiology (JACC) reviewed randomized controlled trials (RCTs)—gold-standard studies evaluating medical interventions—from 2019 to 2024 across leading general medical and cardiovascular journals. It found that only 3.9% of general medical RCTs were conducted exclusively in Africa, dropping to a mere 0.6% for cardiovascular-focused trials. This gap raises serious concerns about the applicability of trial results to African patients, where genetic diversity, environmental factors, and disease patterns differ significantly from those in Europe or North America.

South African universities are at the forefront of addressing this disparity, leveraging their research infrastructure to host trials, train investigators, and advocate for greater inclusion. Institutions like the University of Cape Town (UCT), University of the Witwatersrand (Wits), and Stellenbosch University are not only participating in but leading efforts to boost African representation, ensuring that clinical research reflects the continent's realities.

South Africa's Dominant Role in African Clinical Research

South Africa accounts for the majority of Africa-based RCTs, dominating with 67.5% of exclusive African trials in top journals and over 62% in recent reviews. This leadership stems from robust clinical trial units (CTUs) embedded in universities, which facilitate everything from patient recruitment to data management. Southern Africa, spearheaded by South Africa, handles about 66.9% of continent-wide trials, while central Africa lags with minimal involvement.

Over 4,000 trials have been initiated in South Africa via ClinicalTrials.gov, outpacing neighbors like Kenya and Nigeria combined in sub-Saharan Africa. University-hosted CTUs, such as those at UCT and Stellenbosch, drive this, with industry-sponsored Phase II-IV trials comprising around 70% of African efforts. These academic hubs ensure ethical oversight, community engagement, and high retention rates—often exceeding 85%—making South Africa an attractive site for global sponsors.

University of Cape Town: Pioneering Infectious Disease Trials

UCT's Clinical Research Centre (CRC) in the Faculty of Health Sciences serves as a cornerstone for trials spanning malaria to non-communicable diseases (NCDs). The Centre for Lung Infection and Immunity (CLII) within UCT's Lung Institute leads RCTs on tuberculosis (TB) and HIV, critical given Africa's high burden. In 2024, UCT partnered with McMaster University on a landmark trial testing low-cost antibiotics to curb HIV-related deaths among 8,000 advanced-HIV patients restarting antiretroviral therapy (ART). This initiative underscores UCT's commitment to locally relevant research, addressing gaps where infectious diseases dominate 75.9% of Africa-only trials.

Additionally, UCT's involvement in gene-editing trials marks Africa's first for hereditary angioedema, highlighting its push for innovative therapies tailored to African genetics. These efforts train the next generation of researchers through integrated programs, fostering diversity in trial leadership—44.6% African-led in South Africa-only studies.

Wits University: Bridging Pre-Clinical to Clinical Gaps

The University of the Witwatersrand addresses underrepresentation upstream in pre-clinical studies, where over 97% of cell lines are European-derived, skewing drug efficacy for Africans. A 2025 Wits opinion piece calls for African-origin models like 3D organoids to capture genetic and lifestyle diversity. Partnering with University College London and the Infectious Disease and Oncology Research Institute (IDORI), Wits developed a platform for cancer and infectious disease modeling, integrating multi-omics and AI.

Wits' Perinatal HIV Research Unit (PHRU) excels in HIV prevention RCTs, while the Diagnostic Innovation Hub (DIH) and BioHub support trial logistics. Capacity-building workshops on 3D modeling promote equity, equipping African scientists for inclusive research and commercialization.

Photo by Ezebunwo Omachi on Unsplash

Stellenbosch University: Innovation Through ACTI and CTUs

Stellenbosch University's Clinical Trials Unit (SUN-CTU), NIH-funded, collaborates with FAMCRU and the Desmond Tutu TB Centre on pediatric TB/HIV Phase I-III trials. In October 2025, it launched the Africa Centre for Therapeutic Innovation (ACTI), a transdisciplinary hub advancing drug discovery from chemistry to pharmacology, targeting Africa's healthcare needs like NCDs and antimicrobials. ACTI reduces import reliance, fostering homegrown solutions.ACTI website

SUN-CTU's high-capacity setup ensures patient-centered trials, with Erick Strauss leading next-gen antibiotic research for Gram-negative bacteria—vital amid rising resistance.

Other Key Players: UKZN, UP, and Beyond

The University of KwaZulu-Natal (UKZN) hosts Africa's first dedicated CTU at its Nelson R. Mandela School of Medicine, focusing on HIV/TB via the Discover Me South Africa study with AstraZeneca. The University of Pretoria's Clinical Research Unit (CRU) provides ethical services for multi-phase trials, while the University of the Free State (UFS) and Nelson Mandela University (NMU) tackle emerging NCDs.

The South African Medical Research Council (SAMRC) collaborates with these unis, funding HIV vaccine trials like Brilliant-011 (launched 2026 in Cape Town) and R6 million for women-led drug discovery. These partnerships amplify university impacts.

Barriers Hindering Progress

Despite advances, challenges persist:

• Lack of dedicated research teams and skilled staff (31.8% cite this).
• Reliable internet (32.6%) and infrastructure deficits.
• Regulatory delays and historical mistrust from neocolonial practices.
• Funding skew toward infectious diseases, neglecting NCDs like CVD.

Capacity Building and Training in SA Higher Education

SA universities prioritize training: UCT's CRC offers tools for early-phase trials; Wits' workshops build 3D modeling skills; Stellenbosch's ACTI integrates education. SAMRC's Grand Challenges support women leaders, while NIH grants to SA scientists (restored 2025) bolster CTUs. These programs enhance African authorship—from 44.6% lead in local trials to rare in global ones—promoting equity.

Photo by Francisco Venâncio on Unsplash

Impacts on Health Equity and Future Outlook

Increased inclusion ensures drugs work for Africans, vital as NCDs rise. SA's model—high consent (80%+) and retention—positions it for growth, with 2026 predictions of surges in NCD trials.Full JACC study University investments in genomics (e.g., SAMRC precision medicine) and AI could transform outcomes.

Future: Pan-African networks, policy reforms, and funding for central Africa. SA unis like UCT and Wits exemplify how higher education drives solutions, ensuring Africa's voice in global health.