Why Calls to Diversify Trial Populations Fall Short.

Area of Science:

• Public Health
• Clinical Trials
• Health Equity

Background:

• Structural racism profoundly impacts health outcomes for Black, Indigenous, and People of Color (BIPOC) communities.
• Clinical trial diversity is crucial but insufficient to address systemic inequities.
• Previous research highlights disparities in healthcare access and outcomes for BIPOC populations.

Purpose of the Study:

• To examine how clinical trial designs, using a SARS-CoV-2 vaccine trial in a Latinx community as a case study, may perpetuate or exacerbate structural racism.
• To critically assess the limitations of diversity initiatives in clinical trials for addressing deep-rooted health inequities.
• To explore potential harms introduced by trial designs that do not account for socioeconomic and historical disadvantages.

Main Methods:

• Qualitative analysis of a SARS-CoV-2 vaccine trial conducted in a Latinx community in San Diego.
• Examination of trial protocols and community engagement strategies.
• Review of existing literature on structural racism and clinical trial participation.

Main Results:

• The study reveals that the trial design, despite aiming for diversity, did not effectively redress existing structural racism.
• Participant recruitment and trial procedures may have inadvertently introduced new harms or failed to mitigate existing ones.
• Relying solely on participant diversity without addressing underlying systemic issues is inadequate for achieving health equity.

Conclusions:

• Clinical trial designs must actively dismantle structural racism rather than merely aiming for demographic diversity.
• Addressing entrenched inequities requires a multi-faceted approach beyond participant numbers, focusing on systemic change.
• Future trial methodologies should prioritize community-centered approaches that acknowledge and counteract historical and ongoing injustices faced by BIPOC communities.