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. 2025 Jul 22;80(Supplement_1):S1-S8.
doi: 10.1093/cid/ciaf094.

Enhancing Clinical Trial Sites in Low- and Middle-Income Countries to Facilitate Product Development in Response to the COVID-19 Pandemic

Sophie S Y Kang  1   2 , Birkneh Tilahun Tadesse  1   3   4   5 , Hyon Jin Jeon  1   6   7 , Mosoka P Fallah  8 , Nebiyu Dereje  8 , Olayinka Stephen Ilesanmi  8 , Solomon Mequanente Abay  1   9 , Betelhem I Tekle  1 , Hayoung G Son  1 , Laxman Shrestha  10 , Anita Shrestha  10 , Hasia V Ramiso  11 , Vincent Canouet  1 , Yeonseon Kim  1   6 , Kwaku Poku Asante  12 , Japhet Anim  12 , Seyram Kaali  12 , Maria Rosario Capeding  11   13 , Ilesh V Jani  14 , Igor Capitine  14 , Arlete Mahumane  14 , T Anh Wartel  1 , Andrea Haekyung Haselbeck  1 , Tarun Saluja  1 , Florian Marks  1   5   6   7   15
Affiliations

Enhancing Clinical Trial Sites in Low- and Middle-Income Countries to Facilitate Product Development in Response to the COVID-19 Pandemic

Sophie S Y Kang et al. Clin Infect Dis. .

Abstract

Background: The swift development of coronavirus disease 2019 (COVID-19) vaccines marked a monumental effort in global coordination and collaboration; however, there remained major disparities in vaccine access and research capacity across countries. Unequal participation in vaccine development studies from low- and middle- income countries (LMICs) clearly signaled an urgent need to strengthen health research infrastructure in those regions.

Methods: With funding from the Gates Foundation (GF), this site readiness initiative carried out rapid capacity enhancement activities to enable large-scale, Phase 3 pivotal clinical trial conduct in LMICs. The International Vaccine Institute (IVI) worked with site partners in four countries (Mozambique, Ghana, Nepal, and the Philippines) after conducting feasibility assessments for site selection. Site-specific gaps were identified, and capacity building activities focused on staff training, site infrastructure, and resource mobilization were carried out over roughly 7 months from October 2020 to May 2021.

Results: Despite pandemic-related challenges such as supply chain shortages, by the end of the capacity building efforts all sites were either contracted to or in discussions with trial sponsors to conduct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine studies. This article provides an overview of the site selection process, critical components of site establishment, and final site readiness evaluations carried out amidst a global health emergency.

Conclusions: This experience illustrates the value of research capacity enhancement as essential to both pandemic preparedness and global health equity. The lessons learned are being carried into an ongoing initiative across West Africa, currently underway as the "Advancing Research Capabilities in West Africa (ARC-WA)."

Keywords: COVID-19; capacity enhancement; clinical trial; pandemic preparedness; vaccine.

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Conflict of interest statement

Potential conflicts of interest. The author reports no conflicts of interest in this work. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Site readiness project road map. Abbreviations: COVID-19, coronavirus disease 2019; IRB, institutional review board; EC, ethical committee; SOP, standard operating procedure; IP, investigational product; PPE, personal protective equipment; CV, curriculum vitae.
Figure 2.
Figure 2.
Selected sites.
Figure 3.
Figure 3.
Grant utilization by category.
See this image and copyright information in PMC

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