Addressing diversity, equity, and inclusion challenges in clinical trials: a narrative review and commentary through a human rights lens

Abstract

This Thesis critically examines the persistent underrepresentation of marginalised populations in clinical trials through the lens of international human rights law. Despite compelling scientific and ethical imperatives for inclusivity, groups such as racial minorities, women, older adults, and persons with disabilities remain systematically excluded. This exclusion stems from a complex interplay of structural, institutional, legal, societal, and individual barriers, including centralised research infrastructure, restrictive eligibility criteria, historical mistrust, and inadequate regulatory enforcement. The Thesis argues that such underrepresentation constitutes a violation of fundamental human rights, particularly the rights to health, to benefit from scientific progress, and to non-discrimination, as enshrined in international and European legal frameworks. While current DEI strategies offer a roadmap for reform, a critical analysis reveals a risk of performative inclusion, where market logic often overrides rights-based obligations, and epistemic injustices devalue marginalised knowledge. The Thesis concludes that achieving genuine equity demands a transformative shift: from symbolic representation to legally binding mandates, robust accountability, and a fundamental redistribution of power within the clinical research ecosystem, ensuring science serves as an equitable public good.