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    SAMJ: South African Medical Journal

    versión On-line ISSN 2078-5135versión impresa ISSN 0256-9574

    SAMJ, S. Afr. med. j. vol.116 no.3 Pretoria abr. 2026

    https://doi.org/10.7196/SAMJ.2026.v116i3.4479 

    CORRESPONDENCE

     

    Tackling clinical trials disparities in Africa

     

     

    To the Editor: Africa houses ~18.8% of the world population and carries 20% of the global disease burden, but only 4% of all clinical trials (and only 1% of cancer trials) are registered on the continent. This disparity calls for immediate action from local and international stakeholders.

    Clinical trials are the bedrock of drug development, and lately, numerous pitfalls linked to regulatory, ethical and patient diversity in trial design have come to light that spotlight the disparities in oncological care, especially in Africa. To date, the most comprehensive data on global cancer clinical trials have been compiled by the World Health Organization (WHO) through their International Clinical Trials Registry Platform and Global Observatory on Health Research and Development.[1] Beside informing policy practice, this timely analysis of 89 069 cancer clinical trials highlights the imbalance in drug development efforts, where high-income countries dominate the clinical trial landscape, and only 3% of clinical trials involved multinational collaborations between 1999 and 2022.

    Africa's cancer burden is expected to double by 2040,[2] and still the continent has the lowest cancer clinical trial numbers (1% of global trials). This is extremely problematic considering the projected sharp increase in cancer burden in the decades to come, owing to rising population, a changing urbanisation landscape and lifestyle changes. Africa is not ready to tackle the upcoming 'cancer pandemic', as limited availability of oncology treatments and under-representation in cancer clinical trials pose unsurmountable challenges if no measures are introduced soon.

    Why has the African clinical trial landscape not proliferated in the past, and what can be done in the future? One of the main limiting factors is the bureaucratic pipeline for approval of clinical trials in Africa. The time to trial activation at a trial site can take between 199 and 399 days,[3] which poses a hurdle to selecting sites for international multicentre clinical trials. This inefficiency in the system may be a result of lack of knowledge around clinical trial workflows, limited availability of skilled personnel and regulatory approval process hurdles and lack of previous experience in performing clinical trials in Africa. The mitigation of these limiting factors would require strategic investment in Africa to prioritise research and development efforts across the continent, on which Africa currently spends <0.5% of GDP, v. 2.2 globally. Additionally, policy changes could play huge role in improving the situation, as exemplified by India.[4] Africa must learn from such examples to find the right strategies to boost clinical trial registrations and research and development efforts on the continent through government and public partnerships. Foundations such as Science for Africa could bridge the gap through building research capacity, and by increasing investments through its Clinical Research and Trials Community programme.[5]

    The resulting increased number of clinical trials including African populations will not only bring diversity to the patient pool for testing the toxicity and safety of drugs, but will also improve access to life-saving medications for people living in Africa. The WHO estimated that Africa had an economic toll of 2.4 trillion international dollars in 2019 due to illness.[6] Therefore, the work by Casolino et al.[1] is a wake-up call for African governments, international pharmaceutical companies and funding agencies to join hands to address the disparities in clinical trials-based research.

    Conflicts of interest. None.

    M Kaur

    School of Molecular and Cell Biology, Faculty of Science, University of the Witwatersrand, Johannesburg, South Africa

    mandeep.kaur@wits.ac.za

     

    References

    1. Casolino R, Tatah L, Charnaud S, Santero M, Ilbawi A, Ross AL. The WHO global landscape of cancer clinical trials. Nature Med 2025;31(9):2901-2912. https://doi.org/10.1038/s41591-025-03926-x        [ Links ]

    2. Sharma R, Aashima, Nandaet M, al. Mapping cancer in Africa: A comprehensive and comparable characterization of 34 cancer types using estimates from GLOBOCAN 2020. Front Public Health 2022;10:839835. https://doi.org/10.3389/fpubh.2022.839835        [ Links ]

    3. Saleh M, Sharma K, Shamshudin A, Obayo I, Gondi S, Karimi N. Regulatory approval of clinical trials: Is it time to reinvent the wheel? BMJ Glob Health 2024;9(1):e013727. https://doi.org/10.1136/bmjgh-2023-013727        [ Links ]

    4. Mankan AK, Shankar A, Limayeet S, et al. Cancer trials ecosystem in India - ready for prime time? JCO Glob Oncol 2024;10:e2300405. https://doi.org/10.1200/go.23.00405        [ Links ]

    5. Science for Africa Foundation. Clinical Research and Trials Community (CRTC). Nairobi: SFA Foundation, 2026. https://scienceforafrica.foundation/clinical-research-and-trials-community (accessed 16 March 2026).         [ Links ]

    6. World Health Organization. A heavy burden: The productivity cost of illness in Africa. Geneva: WHO, 2019. https://www.afro.who.int/publications/heavy-burden-productivity-cost-illness-africa        [ Links ]