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Vulnerable Population Protection: Structural Inequalities in Clinical Trial Investment

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Keywords:

vulnerable population, Clinical trial, Investiment

Abstract

VULNERABLE POPULATION PROTECTION: STRUCTURAL INEQUALITIES IN CLINICAL TRIAL INVESTMENT

Background: Clinical trials inform healthcare decisions worldwide, but inequalities remain. In African contexts, vulnerable groups such as refugees, prisoners, and pregnant women are frequently excluded or included without sufficient protection. While Uganda has maintained a strong ethical framework for clinical trials, ensuring the consistent application of these safeguards remains a challenge.

Objective: To examine whether patterns in protecting vulnerable populations in African clinical trials expose underlying structural disparities in research investment and governance.

Methods: A cross-sectional audit of interventional trials registered on ClinicalTrials.gov through April 2026 was performed. Eligible studies included 3,515 African and 159,433 trials in the United States. The primary outcome was the odds ratio of trial participation based on registry data, with trends over time evaluated.

Results: Africa contributed fewer trials, with a 45-fold disparity compared to the United States. Although registrations saw a 17.1-fold increase, differences persisted. Patterns also indicated inconsistent protection of vulnerable populations.

Conclusion: Structural limitations in governance and investment still restrict fair participation and protection in African clinical trials. Findings are limited by the reliance on a single registry and the exclusion of non-English databases.

References

UNCST. (2025). Uganda National guidelines for research involving humans as research participants (September).

Wendler, D. (2020). When and how to include vulnerable subjects in clinical trials. Clinical Trial, 17(6), 696–702. https://doi.org/10.1177/1740774520945601

Yelgar, S. K., Kasaria, L. S., & C.S. Mujeebuddlin. (2020). Vulnerability in Clinical Trials. 64(01), 1–6. https://doi.org/10.47583/ijpsrr.2020.v64i01.001

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2026-06-06

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How to Cite

Vulnerable Population Protection: Structural Inequalities in Clinical Trial Investment. (2026). Synthesis, 2(4). https://synthesis-medicine.org/index.php/journal/article/view/86

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