Figure 3. Recommendations for SCD trials

Source: IQVIA Research and Development Solutions and EMEA Thought Leadership

Furthermore, bringing the perspectives of people living with SCD into the picture enables the calibration of clinical research activities across the board by raising awareness of communities around the objectives and results of clinical trials (and even more so on what they entail), reducing dropouts, and listening more intently to their needs. During the Fifth Global Congress on Sickle Cell Disease in Abuja¹⁰ a representative from a patient advocate organization highlighted that trial participants are often faced with a lack of understanding about the research, lengthy trial periods, difficulties moving between rural areas and clinical sites due to costs and distance, interruption to work activities or school, and fear of side effects. Against this backdrop, community advocacy and support to participants are pivotal tasks and key success factors.

In summary, incorporating these considerations into the value chain of clinical trials with similar levels of complexity, focusing on those addressing cardiometabolic and oncological conditions, can attract new sponsors, expedite pharmaceutical discovery, facilitate access to vulnerable and underserved groups, and improve population health. In the case of NCDs, the sustained deployment of local innovation is extremely relevant and timely, considering that Africa is experiencing a considerable surge in the prevalence of—and mortality due to—these conditions. NCD-related deaths increased from 24.2% in 2000 to 37.1% in 2019, versus a decrease in those associated with communicable diseases.¹¹ Figure 4 presents this trend and compares it with the current disease burden in Africa.

Figure 4. NCD-related mortality in the WHO Africa region (2000-2019), both sexes, and disease burden globally and in Africa in 2019

Source: WHO Global Health Observatory data¹² processed by IQVIA EMEA Thought Leadership

Realizing a stronger clinical research ecosystem in Africa

The past five years have brought a quiet but meaningful change in how clinical research is regulated and executed in Africa. From harmonized regulatory frameworks to more collaborative ethics review processes, countries are steadily improving the predictability and efficiency of trial approval pathways. Organizations like the African Vaccine Regulatory Forum (AVAREF) and the African Medicines Agency (AMA) have accelerated cross-border regulatory alignment, offering a platform for joint reviews, reliance models, and faster timelines. For instance, Ghana’s FDA is implementing an accelerated review process for priority therapies, Rwanda has piloted adaptive oversight approaches, and Kenya is progressively adopting joint review mechanisms between its Pharmacy and Poisons Board and national ethics committees.

As of July 2025, Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe have achieved WHO Maturity Level 3 (ML3) status, indicating that their national regulatory authorities meet international benchmarks for quality, safety, and oversight of medical products.¹³ This level of maturity enables these agencies to lead and support multi-country trials that adhere to international standards. In tandem, many of these regulators are on a path to operationalizing reliance pathways, a mechanism that allows one authority to leverage the review work done by another trusted regulator to inform its own decisions. This approach, endorsed by WHO, will help accelerate clinical trial approvals while maintaining high regulatory standards in resource-constrained settings.¹⁴

Building on this momentum, the AMA is stepping into its role as a unifying continental force, with its first Director General appointed in June 2025. In May 2024, the AMA signed a memorandum of understanding with seven ML3-certified national regulatory authorities to strengthen collaboration on joint dossier reviews, shared inspections, and aligned reliance models.¹⁵ Egypt officially joined this alliance shortly thereafter. These efforts are reducing approval timelines, enhancing predictability and sponsor confidence in Africa’s ability to conduct high-quality, integrated clinical research at scale. Together, the convergence of regulatory maturity, regional reliance, and AMA’s leadership is transforming what was once a fragmented regulatory environment into one that is more aligned, efficient, and capable of catalyzing advanced clinical research activities.

These institutional and operational transformations are promising, but they are not applied consistently. Some countries still grapple with limited capacity, fragmented policies, or unreliable timelines. Yet, the appetite for reform is clear and supported by the evolving maturity of the clinical research infrastructure, reflected in the growing number of clinical sites and trials and the focus on novel therapies.

The importance of more clinical research in Africa: Investments as a win for all

Leveraging the capacity built through SCD trials, Africa’s vast experience in infectious diseases, and recent evolutions in the regulatory landscape can accelerate NCD-focused studies in disease areas like diabetes, breast cancer, obesity, stroke, and hypertension, all of which, as indicated earlier, are increasing in prevalence on the continent. Therefore, these trials are paving the way for a broader clinical research ecosystem and, as a result, facilitating the identification of much-needed answers for major public health threats.

This research landscape is also creating an optimal environment for home-grown solutions that are tailored to distinctive population needs and genomic specificities. More inclusive trials strengthen scientific validity, which is something that global researchers have acknowledged in recent years, especially in oncological care research, where African ancestry populations remain underrepresented. Access-wise, a stronger clinical research capacity enables patients in need to enjoy the benefits of new innovations faster. Studies have shown that the presence of clinical trials in African countries correlates with increased drug approvals.¹⁶

Community ownership does not only improve trust in these interventions but also serves as a conversation starter that raises awareness on specific diseases and exposes patients to positive health outcomes. For instance, IQVIA’s experience in investigating the use of paliperidone palmitate in Rwanda for schizophrenia reveals that placing communities at the center—that is, understanding the impact of a given condition through the voice of patients and making them part of the solution—can have positive effects on local buy-in, the retention of trial participants, and access to care.¹⁷ Similarly, the engagement of communities and patient organizations in SCD studies has contributed to the fine-tuning of clinical research operations in countries like Ghana, Nigeria, Kenya and Tanzania. Therefore, the perspectives of patients should remain pivotal as part of the advocacy efforts to bring more NCD trials to Africa.

Finally, investing in clinical trials goes beyond product pipelines and trial placement. Structured funding and capacity-building can deliver countless knowledge assets, empowered and more skilled investigators, and bolstered local ownership.¹⁸ In the case of neglected diseases alone, it is estimated that every dollar invested in clinical research has a return of US$405 in wider societal and economic gains. Taking a retrospective look, the same study indicates that product development in Africa between 2000 and 2022 has averted nearly 600 million disability-adjusted life years (DALYs), a favorable outcome that could be expanded if the right conditions continue to be in place.¹⁹

Keeping this momentum requires scaling up investment in clinical research infrastructure and workforce capacity, maintaining the impetus behind regulatory progress, and driving stronger partnerships that support truly inclusive, diverse, and impactful trials. By moving farther in this direction, high-quality clinical research in Africa will drive more than just groundbreaking pharmaceutical discoveries: it will ultimately foster much healthier, economically vibrant, and resilient societies.

References

¹ Tshilolo, L. et al. (2018). Hydroxyurea for children with sickle cell anemia in sub-Saharan Africa. The New England Journal of Medicine, 380(2), 121-131. DOI: 10.1056/NEJMoa1813598

²Aygun, B. et al. (2024). Hydroxyurea dose optimization for children with sickle cell anemia in sub-Saharan Africa (REACH): extended follow-up of a multicenter, open-label, phase 1/2 trial. Lancet Hematology, 11(6), E425-E435. https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(24)00078-4/abstract

³ Thomson, A. et al. (2023). Global, regional, and national prevalence of mortality burden of sickle cell disease, 2000-2021: A systematic analysis from the Global Burden of Disease study 2021. The Lancet, 10(8), 585-599. DOI: 10.1016/S2352-3026(23)00118-7

⁴ International Monetary Fund (2023). A demographic transformation in Africa has the potential to alter the world order. https://www.imf.org/en/Publications/fandd/issues/2023/09/PT-african-century#:~:text=The%20United%20Nations%20projects%20that,world's%20population%20will%20be%20African.

⁵ See reference 3.

⁶ Costa, E. et al. (2025). Globalization in clinical drug development for sickle cell disease. American Journal of Hematology, 100(1), 4-9. DOI: 10.1002/ajh.27525

⁷ ClinicalTrials.gov (n.d.). Search for sickle cell card results. Retrieved on July 7, 2025. Search for: sickle cell | Card Results | ClinicalTrials.gov.

⁸ Opoka, R. Et al. (2020). Hydroxyurea to lower transcranial Doppler velocities and prevent primary stroke: The Uganda NOHARM sickle cell anemia cohort. Haematologica, 105(6), 272-275. DOI: 10.3324/haematol.2019.231407

⁹ See reference 2.

¹⁰ Sickle Cell Support Society of Nigeria and Global Sickle Cell Disease Network (2025). Fifth Global Conference on Sickle Cell Disease. https://www.globalsicklecellcongress.com/

¹¹Barry, A. (2025). Noncommunicable diseases in the WHO African region: Analysis of risk factors, mortality, and responses based on WHO data. Scientific Reports, 15. DOI: doi.org/10.1038/s41598-025-97180-3

¹² World Health Organization (n.d.). The Global Health Observatory. Search for number of deaths caused by NCDs in the WHO Africa region. Retrieved on August 5, 2025. https://www.who.int/data/gho

¹³ World Health Organization (2025, August 7). Regulatory system strengthening: WHO-listed authorities. https://www.who.int/initiatives/who-listed-authority-reg-authorities

¹⁴ Valentin, M. (2020). Good reliance practices in regulatory decision-making: High-level principles and recommendations. WHO Drug Information, 34, 201.

¹⁵ See reference 11.

¹⁶ Strüver, V. et al. (2021). Patient benefit of clinical research in diversely advanced African developing countries. Current Therapeutic Research, 96, 100656. DOI: 10.1016/j.curtheres.2021.100656

¹⁷ Mora-Brito, D. (2024). IQVIA Africa Health Summit 2023. Executive summary. IQVIA. https://www.iqvia.com/-/media/iqvia/pdfs/mea/brochures/iqvia-africa-health-summit.pdf

¹⁸ Addo, J. et al. (2020). Supporting the next generation of noncommunicable disease research leaders in Africa. The experience of the GSK Africa NCD Open Lab. Journal of Global Health Reports, 4. DOI: 10.29392/001c.12274

¹⁹ Impact Global Health (n.d.). The impact global health R&D. Retrieved on August 5, 2025. https://impact.impactglobalhealth.org/research-investment