The drive to more diverse, equitable and inclusive trials

For these reasons the Food and Drug Administration (FDA) is actively promoting enrollment practices that ensure broader representation in clinical trials. The aim is to reduce bias, promote social justice, improve health equity, and drive scientific innovation 2 . Additionally, the National Academies of Science, Engineering, and Medicine (NASEM) have developed diversity, equity, and inclusion (DEI) guidelines to encourage participation from various demographic groups, including individuals of different genders, races, ethnicities, socioeconomic backgrounds, and more 1 . The National Academies of Science, Engineering, and Medicine (NASEM) have also developed diversity, equity, and inclusion (DEI) guidelines to encourage participation from various demographic groups, including individuals of different genders, races, ethnicities, socioeconomic backgrounds, and more 1 .

DEI guidelines in practice

Research teams and clinicians are enhancing DEI efforts by adopting DEI guidelines throughout the research timeline from trial design to the regulatory process. The FDAs proposed strategies suggest reducing patient burden by minimizing study visits, offering financial reimbursements and providing resources in multiple languages 4 . Community engagement strategies emphasize sponsor collaboration with advocacy groups and holding recruitment events outside of clinical settings. Using telehealth services and flexible visit schedules can address the needs of underrepresented groups such as those living in remote areas or with cognitive impairments.

Using systemic literature reviews to design inclusive trials

An essential element of designing a trial to engage with diverse communities is carrying out a systemic literature review (SLR). Sponsors planning clinical trials can use an SLR to draw insights on the demographics of treatment populations. SLRs can provide details including the incidence, prevalence, risk factors and treatment responses of the relevant disease in different target populations. This comprehensive analysis can identify gaps in representation and provide a foundation to design a more inclusive, representative clinical trial. Used in this way SLRs directly support the FDAs goal of more diverse clinical trials that better reflect real-world populations. This can ensure that research findings are generalizable across different communities. The FDAs guidance documents provide a comprehensive framework for sponsors to create inclusive, participant-centric trial designs that engage diverse communities while reducing participant burdens 4 . SLRs are an essential element of this framework, offering data-driven insights that inform the development of more inclusive trials. By enabling detailed assessments of treatment efficacy and safety across diverse populations, SLRs contribute to more equitable and impactful clinical research practices.

Conclusion

Ensuring that clinical trial patients are diverse and reflect the real world patient populations is critical to demonstrate the safety and effectiveness of the proposed treatment. Many trial design factors contribute to attracting a more diverse patient cohort to a study, including decentrialising trials, reimbursing patients trial-related expenses and translating communications into multiple languages. SLRs can provide sponsors with vital insights to inform their trial design to ensure a diverse patient cohort that accurately represents the treatment population. At ICON Health Economics & Epidemiology , we have a broad range of expertise to support diversity and equity planning in clinical trials. One such expertise lies in conducting these literature reviews to help understand the demographics of a treatment population. At a minimum such reviews can inform the incidence, prevalence, risk factors, and treatment response of a disease with details of distribution within a geographical region to provide the basis for designing clinical trials. References

Versavel S, Subasinghe A, Johnson K, et al. Diversity, equity, and inclusion in clinical trials: A practical guide from the perspective of a trial sponsor. (1559-2030 (Electronic)).

NIH. The Importance of Diversity and Inclusion in Clinical Trials. In: Services USDoHaH, ed. Diversity and Inclusion in Clinical Trials. Vol 2024. Bethesda, Maryland: National Institutes of Health; 2024.

Washington V, Franklin JB, Huang ES, Mega JL, Abernethy AP. Diversity, Equity, and Inclusion in Clinical Research: A Path Toward Precision Health for Everyone. Clinical Pharmacology & Therapeutics. 2023;113(3):575-584.

FDA. Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. In: Services USDoHaH, ed. Silver Spring, Maryland: FDA; 2020.