In recent years, the demand for greater diversity in clinical trials has become a defining issue in clinical research. Historically, clinical trials have been criticized for underrepresenting racial and ethnic minorities, women, older adults, and other underserved populations. This lack of inclusion not only leads to inequities in healthcare outcomes but also undermines the generalizability of clinical data.
Diversity in clinical trials isn’t just a social imperative – it’s a scientific and regulatory one. As regulators around the world move toward stronger guidance and expectations on inclusivity, sponsors and CROs must adapt by integrating diversity strategies early and intentionally into clinical trial planning.
In this blog, we explore the importance of diversity, key regulatory expectations, and strategies sponsors can adopt to meet both ethical and scientific demands while enhancing trial success.
Why Diversity in Clinical Trials Matters
1. Health Equity and Fair Representation
Diverse populations often experience disproportionate rates of disease, yet remain underrepresented in clinical studies. Without their inclusion, drugs may be less safe or effective for those groups. Promoting diversity ensures all patients benefit equally from medical advancements.
2. Scientific Accuracy and Generalizability
Pharmacokinetics and pharmacodynamics can vary significantly based on race, age, sex, and comorbidities. Trials that lack diversity may produce skewed data, limiting their external validity and leading to ineffective or unsafe treatments for certain populations.
3. Regulatory Compliance
Regulatory agencies like the FDA, EMA, and MHRA now emphasize diversity as part of trial evaluation criteria. Ignoring this aspect can result in delayed approvals or post-marketing requirements.
4. Public Trust and Engagement
Inclusive trials promote trust in research within historically marginalized communities. Greater trust leads to higher enrollment, retention, and willingness to participate in future research efforts.
Global Regulatory Expectations on Trial Diversity
1. United States (FDA)
The FDA has taken a leading role in encouraging trial diversity. In 2020, the agency released its guidance on enhancing diversity in clinical trials, urging sponsors to:
- Include a Diversity Plan early in trial planning
- Broaden eligibility criteria
- Consider decentralized trial models
- Engage community stakeholders
In 2022, the FDA Omnibus Reform Act made diversity plans a requirement for Phase 3 trials in the U.S., marking a shift from recommendations to mandates.
2. European Union (EMA)
The European Medicines Agency supports inclusive trial design through its ICH E17 and E8(R1) guidelines, emphasizing the need to consider population-specific responses. EMA also urges sponsors to conduct feasibility assessments to ensure site selection supports diversity.
3. United Kingdom (MHRA)
The MHRA encourages transparency and improved access for underrepresented groups, often aligning with global guidance. Sponsors are expected to demonstrate efforts to improve inclusion, especially when seeking fast-track approvals.
4. APAC and Other Regions
Agencies across Asia-Pacific and Latin America are gradually aligning with global expectations. Local patient demographics, access challenges, and cultural sensitivities are important considerations in these regions.
Challenges in Achieving Diversity
Despite growing regulatory pressure and good intentions, sponsors often face practical and systemic barriers to achieving diversity:
- Geographic site selection bias toward affluent urban centers
- Stringent eligibility criteria that exclude older adults or those with comorbidities
- Lack of trust in research due to historical abuses
- Language and cultural barriers
- Inadequate community outreach or awareness
To overcome these, a multi-faceted, intentional approach is needed.
Strategies to Improve Diversity in Clinical Trials
Here are key strategies sponsors, CROs, and research sites can implement to enhance inclusion:
 1. Develop a Diversity Plan Early
Design a comprehensive diversity plan during protocol development. This should include:
- Clear recruitment goals by race, age, sex, and geography
- Site selection criteria that target diverse populations
- Community engagement strategies
- Metrics for tracking progress
2. Broaden Eligibility Criteria
Review exclusion criteria that may disproportionately eliminate minority populations, such as those with chronic diseases or older adults. Aim for flexible inclusion that aligns with real-world patient profiles.
3. Use Decentralized and Hybrid Trial Models
Remote technologies allow for participation without the burden of travel – particularly beneficial for rural, disabled, or low-income participants. Tools include:
- Telemedicine visits
- Mobile nursing units
- Electronic consent (eConsent)
- Wearable monitoring devices
4. Expand Site Selection to Underserved Areas
Instead of defaulting to large academic centers, consider community clinics, FQHCs (Federally Qualified Health Centers), and minority-serving institutions. Partner with local providers to build trust.
5. Train Sites and Investigators on Cultural Competency
Site staff should be trained to address cultural sensitivities, language preferences, and implicit biases. Providing multilingual support materials and having bilingual coordinators can make participation more inclusive.
6. Collaborate with Community Leaders
Engage local faith groups, patient advocacy organizations, and community leaders to build awareness. Their endorsement can significantly improve participation rates.
7. Offer Support Services
Mitigate logistical and financial barriers by offering:
- Travel reimbursements or stipends
- Childcare support during visits
- Transportation coordination
These services reduce the burden of participation and make trials more accessible.
8. Leverage Real-World Data for Site Feasibility
Use demographic and epidemiological data to guide site selection and outreach strategies. This data-driven approach ensures your recruitment plans are grounded in population needs.
The Role of Technology in Enabling Inclusion
Digital transformation in clinical trials plays a pivotal role in achieving diversity:
- Electronic Health Records (EHRs): Help identify eligible participants from diverse backgrounds
- AI and Data Analytics: Predict recruitment gaps and optimize outreach
- Patient Portals: Offer multilingual, user-friendly platforms for enrollment and engagement
Technology isn’t a silver bullet – but when combined with human-centered design, it can be a powerful enabler of inclusion.
Measuring and Reporting Diversity
Regulators now expect sponsors to report demographic data across trial phases. Key metrics include:
- Enrollment by race, ethnicity, gender, age, and geography
- Retention rates across groups
- Discontinuation reasons stratified by demographic
Reporting these insights transparently builds trust and satisfies compliance requirements.
Sponsors should also consider publishing diversity outcomes in trial registries or journal publications to foster transparency and accountability.
Benefits of Inclusive Trial Design
While the road to equitable clinical research may be complex, the rewards are clear:
- Faster recruitment and higher retention
- Stronger regulatory positioning
- Improved drug safety and efficacy insights
- Reduced post-approval risks
- Better public and stakeholder trust
Inclusion is not just a regulatory checkbox – it’s a catalyst for better science and broader impact.
Conclusion
Diversity in clinical trials is no longer a “nice to have” – it’s a regulatory expectation, a scientific necessity, and a moral obligation. As global regulators continue to embed inclusion into their frameworks, sponsors and CROs must evolve from passive acknowledgment to proactive implementation.
Building an inclusive research ecosystem demands early planning, community collaboration, smart technology, and a long-term commitment to equity.
Is your organization prepared to meet the evolving expectations for trial diversity and global compliance?
Partner with MakroCare to design and deliver inclusive clinical trials that reflect real-world populations while meeting global regulatory standards.
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