For decades, many clinical trials have not reflected the true diversity of the communities they aim to serve. Racial and ethnic minorities, rural residents, women, and low-income patients often remain underrepresented in medical research — even though they bear a significant share of the disease burden.
At South Florida Clinical Research Institute (SFCRI), we believe that advancing science means advancing equity. Diversity in clinical trials is not just a moral imperative — it’s essential for developing safe, effective, and inclusive treatments that work for everyone.
This article explores why representation gaps exist, how they affect research quality, and what can be done to build a more inclusive future in clinical research.
Current State: Gaps in Representation
Despite progress, disparities remain clear. According to recent analyses published in ScienceDirect and the National Institutes of Health (NIH), most U.S. clinical trial participants are still non-Hispanic White, even for conditions that disproportionately affect people of color.
For example:
- Black Americans represent ~14% of the U.S. population but only 8% of clinical trial participants. (cancer.gov)
- Hispanic or Latino populations make up 19% of the nation but less than 6% of trial enrollees (nih.gov).
- Older adults, women, and rural communities are frequently excluded due to eligibility or logistical barriers.
These imbalances can bias results and limit generalizability, meaning therapies may not work the same way across all populations. Without representative data, side effects, dosage variations, or response differences may go unnoticed until after a drug reaches market.
Diversity in Clinical Trials: Barriers and Challenges
Achieving diversity in clinical trials requires addressing both systemic and individual-level barriers that discourage participation.
1. Historical Mistrust
Past unethical research practices, such as the Tuskegee Syphilis Study, have left deep scars and long-lasting mistrust within some communities. Rebuilding confidence demands transparency, accountability, and partnerships rooted in respect.
2. Logistical & Financial Barriers
Many potential participants lack access to trial sites, reliable transportation, or paid time off work.
Childcare responsibilities and travel costs can further discourage enrollment — especially among lower-income households.
3. Communication and Health Literacy
Language differences and complex consent forms can alienate non-English speakers or those unfamiliar with medical jargon. Without clear explanations, participation feels intimidating rather than empowering.
4. Geographic Limitations
Most research sites are located near large academic centers, far from rural or underserved areas. This geographic inequity makes participation impractical for many.
5. Restrictive Eligibility Criteria
Strict inclusion rules — such as excluding participants with comorbidities — often remove individuals who represent real-world patients. Broader criteria can better reflect actual treatment populations.
6. Institutional Inertia
Regulatory frameworks and traditional study designs have been slow to adapt to modern needs, perpetuating disparities in recruitment and representation.
Facilitators and Best Practices for Inclusive Research
1. Build Community Partnerships
Collaboration with trusted local organizations, faith leaders, and advocacy groups increases awareness and builds credibility. SFCRI actively engages with South Florida’s diverse communities through outreach events and education campaigns.
2. Practice Cultural Competence
Training research teams in cultural sensitivity, providing bilingual materials, and respecting cultural norms foster trust and participation. Communication must be human-centered, not transactional.
3. Embrace Decentralized and Virtual Trials
Remote monitoring, telemedicine, and mobile data collection make participation possible for those who cannot easily travel. These methods lower barriers while maintaining scientific rigor.
4. Offer Logistical Support
Providing transportation vouchers, flexible scheduling, or compensation for missed work hours can significantly improve participation rates.
5. Rethink Eligibility Criteria
Regulatory bodies and sponsors are now encouraging broader inclusion criteria. This change helps ensure that trial populations mirror the diversity of patients who will ultimately use the therapy.
6. Diversify the Research Workforce
Representation within the research team matters. A diverse workforce fosters empathy, strengthens communication, and increases trust among participants (CTTI).
Policy and Institutional Levers
Regulatory Guidance
In 2024, the FDA issued new guidance requiring sponsors to submit Race and Ethnicity Diversity Plans for all late-stage clinical trials. These plans outline recruitment strategies, site selection, and metrics for inclusive enrollment (Mintz).
Incentives for Sponsors
Some agencies and philanthropic organizations now offer grant funding and extended review benefits to sponsors who demonstrate diversity in recruitment.
Institutional Commitment
Research centers like SFCRI integrate diversity objectives into every study. Our Florida location provides access to a multicultural patient base, allowing us to conduct trials that more accurately represent the nation’s population.
Successful Models: What’s Working
Community-Engaged Research
Programs such as the NIH All of Us Research Program and Diverse & Inclusive Participation in Clinical Research (DIPCR) initiative have shown that direct community involvement leads to higher enrollment among minorities.
These models emphasize co-creation — designing studies with communities rather than for them.
Case Example: Diabetes and Cardiovascular Trials
In several SFCRI-affiliated trials focused on diabetes and cardiovascular health, targeted outreach in Hispanic and Caribbean-American neighborhoods significantly increased participation. Bilingual coordinators, flexible hours, and faith-based partnerships proved particularly effective.
Metrics and Accountability
True progress requires measurable outcomes. Research sponsors and sites should track:
- Enrollment diversity metrics (race, ethnicity, age, sex, socioeconomic background)
- Retention rates across demographic groups
- Subgroup analyses to confirm consistent treatment effects
- Public reporting to promote transparency and continuous improvement
These metrics ensure that diversity goals translate into tangible, sustainable change rather than one-time recruitment efforts.
Recommendations for Diversity in Clinical Trials and Roadmap Forward
| Stakeholder | Short-Term Actions | Long-Term Actions |
| Sponsors | Require Diversity Plans; allocate funds for outreach | Maintain post-market monitoring of demographic outcomes |
| Research Sites | Hire bilingual staff; partner with local health orgs | Build ongoing community relationships, not one-off campaigns |
| Regulators | Strengthen diversity reporting requirements | Incentivize inclusive research through faster approvals |
| Communities | Participate in advisory boards; co-develop materials | Encourage trust through advocacy and shared success stories |
SFCRI integrates these principles by partnering with investigators, community leaders, and sponsors to make inclusive participation a cornerstone of ethical research.
Conclusion: Building Trust, Representation, and a Healthier Future
Achieving diversity in clinical trials isn’t simply a metric — it’s a commitment to fairness, safety, and better science.
By including underrepresented populations, researchers ensure that treatments are effective for all patients, not just a subset.
At South Florida Clinical Research Institute, our mission is to advance healthcare through integrity, compassion, and collaboration. With every study we conduct, we move closer to a future where access to innovation is equitable, and every voice contributes to medical discovery.
Together, we can build clinical research that truly represents the people it serves.
FAQ: Diversity in Clinical Trials
Q1: Why is diversity important in clinical research?
It ensures that results reflect real-world populations, helping doctors understand how treatments work across genetic, cultural, and environmental differences.
Q2: What steps are being taken to improve inclusion?
The FDA now requires Diversity Plans, and research institutions like SFCRI are expanding outreach, bilingual education, and community partnerships.
Q3: How can participants from underrepresented groups join trials?
They can visit ClinicalTrials.gov or contact SFCRI to learn about ongoing studies in South Florida.
Q4: What happens if trials lack diversity?
Treatments may show unanticipated side effects or reduced effectiveness in populations not adequately represented during testing.
Q5: How does SFCRI promote inclusion?
By leveraging Florida’s diverse population, bilingual research teams, and flexible study models to create accessible, culturally competent trials.