The State Of Black Participation In Clinical Trials

Improving diversity in clinical trials is not just the right thing to do, it is necessary for better science, more representative outcomes, and increased health equity. Historically, clinical trials have been shown to recruit disproportionately large percentages of White participants. These skewed participant populations raise concerns about the generalizability of trial results to underrepresented non-White participants and inequitable access to clinical trial treatments.^1,2 The FDA published updated guidance to address these concerns in April 2022, stating that clinical trial participants need to reflect the demographic distribution of the United States (US) population.³

Although the need to design trials that enroll more demographically diverse patients is widely recognized, implementing effective, sustainable, and scalable enrollment diversity strategies remains a challenge for biopharmaceutical companies.4 Some of the main barriers to increasing demographic diversity in clinical trials are: 

• Patient mistrust of the clinical research enterprise
• Geographic and economic factors that discourage participation by communities of color
• Exclusion of diverse communities in research planning and execution
• Lack of clinical investigators from historically marginalized groups⁵