By Abiel Obanjo and Shone Williams
- The Initial Problem: Underrepresentation in Clinical Trials
Clinical trials are essential for medical innovation, yet 72% of trials fail BIPOC (Black, Indigenous, and People of Color) patients due to underrepresentation. This leads to therapies that may not be effective or safe for these populations, perpetuating health disparities and eroding trust in the research process.
- Investigated Solutions: Approaches to Increase BIPOC Representation
Several strategies have been explored to address this challenge:
- Community engagement and partnership
- Diversifying trial sites
- Inclusive eligibility criteria
- Culturally competent materials and staffing
- Regulatory incentives for diversity
Research and industry experience consistently show that community engagement and site diversification are among the most effective approaches.
- Selected Solution: Community-Centered Research Design
Divergent CRO selected a community-centered research design as its primary strategy to improve BIPOC representation. This approach involves partnering with local organizations, designing culturally relevant recruitment materials, and ensuring trial sites are accessible to underrepresented populations.
Why this solution?
Community-centered design addresses both logistical and trust barriers, making trials more inclusive and relevant. It empowers communities to participate as equal stakeholders, leading to improved recruitment, retention, and satisfaction.
- Results: Divergent CRO’s Case Study
Case Study: Divergent CRO’s Diabetes Clinical Trial (2023–2024)
Divergent CRO launched a Phase III diabetes trial in collaboration with community clinics and advocacy groups serving predominantly BIPOC neighborhoods in Atlanta, Detroit, and Houston. Key elements included:
- Community Partnerships: Engaged local health organizations and faith leaders to co-host informational sessions and recruitment drives.
- Accessibility: Provided transportation vouchers, flexible visit scheduling, and on-site childcare.
- Cultural Competence: Employed bilingual staff and developed materials tailored to the cultural and linguistic needs of participants.
- Continuous Feedback: Established advisory boards with BIPOC patient representatives to guide trial processes.
Outcomes:
- BIPOC enrollment increased from 15% (previous trials) to 42% in the diabetes trial.
- Retention rates among BIPOC participants rose by 30%.
- Participant satisfaction scores improved by 35%, with feedback highlighting trust in staff and relevance of trial information.
- Regulatory reviewers cited the trial as a model for diversity and inclusion in clinical research.
Conclusion
The persistent failure of clinical trials to serve BIPOC patients is a critical issue, but Divergent CRO’s experience shows it can be overcome. By prioritizing community-centered research design, clinical research organizations can deliver more equitable, effective, and trusted studies. The path forward requires commitment, collaboration, and transparency to ensure that medical innovation benefits everyone
www.divergentcro.com
Abiel Obanjo and Shone Williams are Divergent CRO Partners. Divergent CRO is a full-service CRO offering comprehensive clinical research solutions. Both Abiel and Shone play integral parts at Divergent CRO. Abiel is a Senior Global Clinical Trial Manager with extensive experience in clinical operations and global trial leadership. Beginning his career as a Clinical Research Assistant, he advanced through roles including Clinical Research Associate and Clinical Operations Manager, building a strong foundation in study execution and oversight. He has successfully managed clinical trials across multiple therapeutic areas, demonstrating versatility and a commitment to advancing medical research. Abiel is dedicated to driving innovation and improving global health outcomes through excellence in clinical research. Shone is a Certified Clinical Research Associate with over 25 years of experience in clinical research, including more than two decades dedicated to oncology trials. Her expertise spans all phases of drug and device studies, with leadership experience as a Lead Senior CRA and Project Management Associate. Known for her deep understanding of oncology research and commitment to clinical excellence, Shone has contributed to the successful development of numerous cancer therapies. She is widely respected for her leadership, expertise, and lasting impact on the field.
