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Enhancing diversity in clinical trials

The role of systematic literature reviews in FDA’s DEI initiatives

By using systematic literature reviews sponsors gain vital insights to inform more inclusive, diverse trial designs aligned with FDA DEI guidelines.

Clinical trials must test the efficacy and safety of their treatments on patient populations that are representative of the treatment population1. This is necessary to assess how patients respond to the treatment as different people may experience the same disease differently2. A trial lacking diversity and representativeness results in gaps in our understanding of diseases and conditions and lead to non-generalizable evidence. These factors could potentially lead to suboptimal means to achieve the best possible outcomes at the individual level2,3. Such deficiencies can potentially affect the quality of healthcare decision making, the design of risk-reduction strategies, and the development of optimal medications and interventions2.

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 innovation2. 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 more1.

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 FDA’s proposed strategies suggest reducing patient burden by minimizing study visits, offering financial reimbursements and providing resources in multiple languages4. 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 systematic literature reviews to design inclusive trials

An essential element of designing a trial to engage with diverse communities is carrying out a systematic 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 FDA’s goal of more diverse clinical trials that better reflect real-world populations. This can ensure that research findings are generalizable across different communities. 

The FDA’s guidance documents provide a comprehensive framework for sponsors to create inclusive, participant-centric trial designs that engage diverse communities while reducing participant burdens4. 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 decentralising 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. 

By: Immaculate Nevis MD, MBA, PhD & Liliane Martinez MD, MSc, ICON Insights, Evidence & Value

References:

1 Stacey Versavel et al 2023. Diversity, equity, and inclusion in clinical trials: A practical guide from the perspective of a trial sponsor. Contemporary Clinical Trials. 

2 NIH Gov Resources. The importance of Diversity and Inclusion in Clinical Trials. 

3 Vindell Washington et al 2022. Diversity, Equity, and Inclusion in Clinical Research: A Path Toward Precision Health for Everyone. Clinical Pharmacology and Therapeutics.

4 FDA. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. 

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