A Multilateral Qualitative Study of Perspectives on Enhancing Clinical Trial Diversity Among Historically Underrepresented Groups.

Purpose: Clinical trial enrollment among underrepresented patient populations remains a critical challenge in biomedical research. This study was conducted for a clinical trial designed to identify biomarkers that would help predict the transition from acute to chronic pain. Specifically, the purpose of this study was to understand the perspectives of multiple stakeholders to characterize the factors that contribute to underrepresented patients' decisions to participate in the trial and inform actionable strategies that can improve trial recruitment and retention.

Methods: Forty-seven participants from a Midwestern US city participated in one-on-one interviews, including 26 patients, 11 healthcare providers and staff, and 10 community-based healthcare organization employees. Interviews were recorded, transcribed, and analyzed inductively by an experienced health services researcher, with results organized into key themes.

Findings: Analysis revealed six major themes about what influences underrepresented patients' participation: Practical barriers to participation, historical context and past experiences impacting research apprehensiveness, communication gaps, and information needs, adapting protocols to address participation barriers, opportunities for building rapport and trust, and motivations and perceived benefits of participating. Common barriers included logistical challenges (eg, distance to medical center), distrust toward medical institutions, and poor communication about clinical trial opportunities, while efforts to intentionally build rapport and trust with patients and community members were identified as opportunities to improve recruitment.

Implications: The results of this study demonstrated that the barriers and enablers to underrepresented patient participation in a clinical trial were diverse and included both systemic and individual factors. These findings were supported across participant groups, suggesting that the engagement of multiple perspectives in the design and implementation of clinical trials play a role in mitigating barriers to clinical trial participation and enhancing participant diversity.