A call to strengthen clinical trials capacity in resource-limited settings

SUMMARY BOX.

• Clinical trials are conducted mostly in the Global North or through North-South collaborations.

• The commentary highlights the importance of conducting clinical trials based in and led by the Global South and fostering South-South research collaborations.

• It advocates for increased government ownership and domestic investment in clinical trials conducted within the Global South and calls for strengthened partnerships to enhance research autonomy and relevance.

Clinical research is sine qua non for understanding and solving public health challenges.¹ Clinical trials are central to advancing scientific knowledge and can have an impact on many areas (but not limited to) new drug development, understanding mechanisms and the identification of biomarkers, which all impact on healthcare and thereby contribute to global and local economies.² Approximately 83% of clinical trials have been conducted in 25 high-income countries; comparatively, less than 5% took place in 91 low- and middle-income countries (LMICs).³ Africa accounts for 18% of the world’s population and bears 20% of the global disease burden, yet less than 3% of clinical trials are conducted on the continent.⁴ Similarly, a disproportionately low number of clinical trials involve participants living in Caribbean nations. During the period January 2007–December 2013, only 10.4% of clinical trials registered on the WHO International Clinical Trial Registry Platform for Latin America and the Caribbean took place in the Caribbean.⁵ Despite the increasing burden of cancer in LMICs, few clinical trials evaluating cancer therapies were conducted in LMICs during the period 2014–2017.⁶ Furthermore, the majority of trials in LMICs are funded by international donors or industry partners rather than by local governments and institutions. This highlights the urgent need for advocacy for sustainable, well-designed and well-executed clinical trials that address health priorities in resource-limited settings.⁷

Recognising this challenge, the Health Development Partnership for Africa and the Caribbean (HeDPAC) and The University of West Indies (UWI) convened a Clinical Trials Capacity (CTC) meeting on 13–14 January 2025 in Kingston, Jamaica, to discuss the status of clinical trials in both regions.⁸ The meeting revealed that Africa continues to grapple with infectious diseases such as malaria, tuberculosis and HIV/AIDS, which remain leading causes of morbidity and mortality. The meeting revealed that both regions face the twin burdens of emerging and re-emerging infectious diseases as well as non-communicable diseases such as heart disease, diabetes, chronic respiratory illnesses and cancer, the latter reflecting progressive epidemiological transitions in lifestyle, ageing populations and urbanisation. Additionally, the situation is compounded by genetic, social and environmental factors that contribute to diseases that disproportionately affect individuals of African ethnicity.9,11 Addressing these diverse health challenges requires robust clinical trials to evaluate new treatments, interventions and preventive strategies tailored to each region’s unique epidemiological and health system context. The rich biodiversity in both regions supports traditional herbal medicine practices. There are tremendous benefits of exploring flora via well-designed pre-clinical studies that could lead to the discovery of novel compounds with positive health benefits.^{12 13}

At the meeting, data from African and Caribbean nations on ongoing research and completed clinical trials were presented. Despite some progress, both regions still lag in conducting large-scale clinical trials due to infrastructural and financial constraints, limited local expertise and complex regulatory landscapes. However, it was noted that there was limited effort to strengthen the African research ecosystems through national actions such as in South Africa, Kenya, Ghana and Uganda.¹⁴ The Caribbean region faces similar challenges. Although there are established health research institutes, centres and networks in the Caribbean, the region struggles with fragmented collaboration, a lack of sustainable funding and underdeveloped regulatory frameworks.⁶

Several persistent challenges hinder the successful implementation of clinical trials in Africa and the Caribbean. To ensure sustained growth and effectiveness of clinical trials in these regions, strategies (box 1) must be prioritised to address these challenges.

Box 1. Strategies to strengthen clinical trials capacity in resource-limited settings with a focus on Africa and the Caribbean.

1. Strengthen regulatory frameworks: countries must continue to harmonise regulatory processes, streamline approvals and enhance ethical oversight to foster a conducive environment for clinical trials.

2. Build research capacity: investments in training programmes for clinicians, researchers and regulatory personnel are essential to develop a robust and skilled workforce.

3. Expand financial investment: establishing regionally led funding mechanisms and engaging the private sector can help reduce reliance on external donors.

4. Enhance community engagement: raising awareness about the benefits of clinical trials through culturally appropriate outreach programmes can improve participation rates and foster trust among local populations.

5. Encourage regional collaboration: cross-border partnerships between African and Caribbean nations can facilitate knowledge exchange, enhance research capabilities and promote joint funding initiatives.

6. Strengthen health systems to improve efficiency of recruitment and identification of clinical outcomes—including the use of electronic health records, systems for coding diagnoses and linking existing databases.

A call for action

The HeDPAC - UWI CTC meeting underscored the urgency in bolstering research capacity, regulatory frameworks and infrastructure to support high-quality clinical trials. These trials are critical for advancing medical knowledge and improving healthcare outcomes in regions facing significant public health burdens. Africa and the Caribbean stand at a pivotal moment in their clinical research journey. By addressing regulatory and infrastructural challenges, fostering strategic partnerships with the private sector and other entities and strengthening research capacity, both regions can create an environment conducive to high-quality clinical trials. It is also essential that governments should prioritise clinical research capacity strengthening through domestic financing and south-to-south partnerships. Such self-sufficiency is critical and timely as global health and medical research are on the cusp of regression following the recent dramatic and abrupt cessation of substantial funding from agencies of the Government of the USA and UK.

Furthermore, the dominance of external funding has often meant that health research in the Global South has been shaped by the priorities of donor countries rather than the communities they aim to serve. These changes in research funding priority and volume by external funders while challenging in the short term, provide an unprecedented opportunity for national governments, local researchers and regional institutions to take a proactive role in charting their health agendas.¹⁵ The signing of a memorandum of understanding between HeDPAC and The University of the West Indies to establish a regional clinical trials hub is a critical first step. For sustainable geopolitical support, we also plan to position clinical trial capacity as an agenda item in the upcoming Ministers of Health and Heads of Government meetings from the two regions. The establishment of the African Medical Agency to harmonise and strengthen regulatory systems throughout Africa also offers an opportunity, in the medium to long term, to strengthen collaboration and south-south partnership to advance clinical trials collaboration between the two regions. Tailored approaches are needed that consider the unique sociocultural, economic and political contexts of the two regions. These must promote advocacy for government policies that prioritise clinical research and domestic funding to expand capacity, ensuring the gains including knowledge transfer are sustained.

Data availability statement

There are no data in this work.