Why You Should Include SDOH In Clinical Trial Recruitment

By Fi Forrest

Housing, health literacy, transportation, and social support are critical social determinants of health (SDOH) that influence the success of clinical trials, beyond standard clinical care. How can the industry better integrate these factors into clinical studies to boost patient recruitment and retention?

Diversity in clinical trials is far more than a regulatory requirement—it is essential for ethical, equitable, and scientifically robust medical research. Historically, the underrepresentation of Black, Asian, and other ethnic minorities in clinical trials has created significant ethical and scientific challenges, limiting the ability to fully understand how treatments affect diverse populations and exacerbating existing health disparities. Recognizing this, the US Food and Drug Administration (FDA) has issued guidance to improve inclusivity in clinical trials.

Importantly, the FDA’s guidance calls for a broader understanding of diversity that goes beyond race and ethnicity. It highlights the need to address socioeconomic barriers—such as financial constraints, geographic access, and community support—that impact participation in clinical trials. By encouraging sponsors to consider factors like trial site locations and community-based care, the guidance aims to break down barriers and facilitate greater engagement from underrepresented populations.

The push for diversity, equity, and inclusion (DEI) has become a priority for global regulatory bodies, including the FDA. Moving forward, clinical trial data may increasingly be required to demonstrate the safety and efficacy of treatments across a variety of subgroups, making inclusivity a critical consideration in trial design.