Clinical Trials in Africa: current situation and perspectives

Africa, home to around 18% of the global population, continues to be underrepresented in global clinical trials—contributing to less than 3% of the total clinical research conducted worldwide (Philpott, 2024; Rickwood, 2024). Despite carrying approximately 25% of the global disease burden, Africa hosts only about 4% of global clinical trials. This under-representation reflects the broader challenges and systemic inadequacies within the continent's clinical research landscape. However, recent advancements and the integration of traditional and herbal medicine research present unique opportunities to overcome these challenges, promising significant public health and economic benefits. Increasing Africa's participation in clinical trials not only addresses public health priorities at a local level but also enriches global health outcomes with unique insights and data. Current Situation of Clinical Trials in Africa Distribution and Focus: Africa's clinical trials landscape is marked by a disproportionately low number of studies, unevenly distributed and concentrated primarily in a few countries like South Africa, Kenia and Egypt (Ndembi et al., 2024). This disparity is compounded by a focus on infectious diseases such as HIV/AIDS, malaria, and tuberculosis, while largely neglecting non-communicable diseases (NCDs) and vaccine research. Although some African countries possess robust regulatory systems—such as South Africa, Ghana, and Nigeria—the overall clinical research infrastructure remains underdeveloped (Philpott, 2024). Potential and Data Gaps: Africa has immense potential for clinical research due to its high genetic diversity and a large, diverse patient pool. Despite significant knowledge diversity due to the high variability in genetic and disease profiles, less than 2% of the genetic data is contributed by African populations in global genomics research (Rickwood et al., 2024). This data gap is critical as it impacts the development and efficacy of treatments tailored to African genetic backgrounds, potentially limiting the continent's health outcomes. Challenges of Conducting Clinical Trials in Africa Regulatory Hurdles: Regulatory complexities and the length of time required for approval processes deter many sponsors from considering African sites (Saleh et al., 2024).Plus, there is no centralized regulatory body like the European Union commission’s Clinical Trials Information System (CTIS). As a consequences, each country has his own regulations, multiplying complexity for sponsors. Infrastructure Deficiencies: Limited research facilities, inadequate technology, and infrastructural flaws further impede clinical research. Many regions lack the necessary laboratories, data management systems, and robust supply chains essential for conducting reliable and timely trials (Ndembi et al., 2024). Funding Constraints and Scarcity of Trained Personnel: Insufficient funding and a shortage of professionals with specialized skills such as epidemiology, pharmacology, and biostatistics contribute to the incapacity for large-scale and complex clinical trials (Saleh et al., 2024). African governments are facing many critical and urgent challenges resulting in few investment in research in general including clinical trials. Ethical and Operational Challenges: Ethical concerns, especially around informed consent and the protection of vulnerable populations, can complicate trial conduct. Socio-cultural barriers, political instability, and logistical issues such as poor transportation networks add layers of difficulty in trial execution (Ndembi et al., 2024). Benefits to Africa from Scaling Up Clinical Research If you ask yourself, why is that important to develop clinical research in Africa? What do we have to gain, in other words what is the missed opportunity? Here are some reasons. Improved Health Outcomes: Participation in clinical research provides early access to cutting-edge treatments and vaccines tailored to the genetic and phenotypic specificities of African populations. It also aids in managing public health priorities more effectively by developing therapies that are locally relevant (Rickwood et al., 2024). Economic Growth: Investment in clinical research enhances local healthcare infrastructure and creates job opportunities for healthcare professionals, researchers, and support staff. These activities generate economic opportunities and drive broader societal gains (Rickwood et al., 2024). Capacity Building: By hosting clinical trials, African countries can foster home-grown innovation and build capacities in medical infrastructure, regulatory frameworks, and human resources. Enhanced local expertise could lead to more cost-effective and sustainable healthcare solutions (Ndembi et al., 2024). Global Health Security: Increased local clinical research participation strengthens the global health response to emerging diseases and pandemic threats, ensuring that African populations are adequately represented in treatment efficacy studies (Philpott, 2024). Equity in Health: More clinical trials in Africa mean better representation of African genetic diversity in global datasets, leading to treatments and interventions that are globally relevant and equitable (Rickwood et al., 2024). Integrating Herbal and Traditional Medicine Research Traditional and herbal medicine (THM) holds a significant position in Africa, where around 80% of the population relies on traditional medicine for primary healthcare needs (Sangho et al., 2024). During the COVID-19 pandemic, the widespread use of herbal remedies highlighted the potential of THM in managing public health crises. Evidence-Based Research: There is a need for rigorous scientific evaluation of herbal medicines to generate clinical evidence of their safety, efficacy, and quality. This can facilitate their integration into conventional healthcare systems (Ngoy Mutombo et al., 2024). The WHO guidelines for clinical trials of herbal medicines in Africa provide a framework for these evaluations (WHO, 2020). Regulatory Frameworks: Harmonizing regulatory processes for herbal medicines across countries can streamline approvals and enhance the credibility of THM. Efforts should focus on creating specific guidelines that align with socio-cultural contexts and ensure the protection of intellectual property rights for traditional medicine practitioners (Sangho et al., 2024). Capacity Building: Training researchers in the ethical and methodological standards for conducting clinical trials on herbal medicines is crucial. Programs like the Multidisciplinary University Traditional Health Initiative (MUTHI) aim to enhance research capacities and improve the quality of clinical trials on herbal medicines (Willcox et al., 2024). Future Perspectives and Strategic Initiatives Addressing the existing challenges and leveraging the unique opportunities requires a multi-faceted strategy: Regulatory Reforms and Streamlining: Simplifying and harmonizing regulatory processes across African countries are essential. The African Medicines Agency (AMA), ratified in 2021, aims to enhance the region’s contribution to clinical research and innovation by strengthening systems for promoting public participation, harmonizing protocols and standards, and leveraging partnerships such as the EDCTP (Hwenda et al., 2022). Capacity Building Programs: Initiatives such as the Clinical Research and Trials Community (CRTC) program focus on building sustainable clinical research systems by increasing investments in ethical clinical trials, fostering stakeholder trust, and enhancing research capacities (Reference 3). Regional and International Collaborations: Strengthening partnerships with international research organizations and private sector entities can help bridge gaps in expertise and funding. Programs such as the Consortium for COVID-19 Vaccine Clinical Trials (CONCVACT) exemplify successful collaborative models (Ndembi et al., 2024). Digital Health Infrastructure: Leveraging digital technologies for remote monitoring, participant recruitment, and data management can streamline clinical trials and widen their reach across the continent (Reference 4). Local Manufacturing and Biobanking: Investments in local manufacturing capabilities for vaccines and treatments along with the establishment of biobanks can enhance Africa's readiness for pandemic response and ensure equitable access to health innovations (Reference 4; WHO, 2021). Funding of clinical trial on herbal medicines by public and private sectors. Investment in herbal medicine will have not only societal impact by developing safe, effective and accessible treatments for the pressing diseases, but will also support economic growth of the pharmaceutical / phytomedicinal industry. Despite its potential, a significant limitation in the scope of clinical trials in Africa is the concentration on infectious diseases, particularly malaria. This narrow focus overlooks the rising burden of non-communicable diseases, which also require urgent research attention and resources. Expanding the spectrum of clinical trials to include these areas is essential for addressing the continent's evolving healthcare needs. In conclusion, while Africa faces significant challenges in expanding its clinical trials landscape, the benefits of doing so are substantial. Through regulatory reforms, capacity building, and enhanced collaborations, Africa can position itself as a vital player in global health research, offering unique insights that contribute to improved health outcomes for all. The integration of traditional and herbal medicine research further enriches this landscape, promising a holistic approach to healthcare that respects cultural practices while embracing scientific rigor. By fostering diverse patient pools and burgeoning infrastructure, Africa is poised to become a superpower in clinical trials, bringing innovative and cost-effective solutions to global health challenges. _______________________ Dr. Abdul Gafar Victoir Coulidiaty is a medical doctor and clinical researcher with extensive expertise in medicine, pharmacology, and clinical research. Holding an MD, an MSc in Pharmacology from the University of Lagos, and an MSc in Applied Biology, his qualifications are complemented by a postgraduate diploma in Clinical Research from the University of Bordeaux and a Bachelor of Science in Psychology. Throughout his career, Dr. Coulidiaty has served as a medical officer and clinical trial researcher in Burkina Faso, coordinating significant clinical trials, such as a phase 3 Ebola vaccine trial. He also has extensive experience in medical affairs, notably as the Medical Fertility Manager at Merck Belgium. Currently, Dr. Coulidiaty is a Clinical Trial Physician at Novartis. He also provides vacation training in Pharmacology and Traditional Medicine at University Nazi Boni in Burkina Faso and has authored a book on traditional medicine. Dr. Coulidiaty is deeply committed to advancing clinical research and public health in Africa. Contact: Phone: +226 70 56 6623 Email: gafarvictoir@gmail.com Social media: LinkedIn: www.linkedin.com/in/gafar-victoir-coulidiaty-06333612a Youtube: Pharmacologie et Médecine en Afrique avec Dr Gafar https://www.youtube.com/ @harmacologieetMedecineenAfriq

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Clinical Trials in Africa: current situation and perspectives

By Dr. Abdul Gafar Victoir Coulidiaty || Burkina Faso & Belgium

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