Building Successful Diversity Initiatives in Clinical Trials through Stakeholder Engagement

This blog was authored by Kelly McKee, VP, DCTs and Patient Registries at Medidata.

Despite ongoing efforts by regulators and industry stakeholders, many clinical trials continue to lack sufficient diversity, perpetuating inequitable access to novel therapeutics. Historically, trial participants have been primarily white and male, which fails to reflect real-world patient populations. Specific subgroups, such as ethnically/racially minoritized people, women, children, seniors, sexual and gender minorities, and socioeconomically disadvantaged populations, are underrepresented. For instance, lung cancer disproportionately affects Black Americans; yet, their enrollment in trials for this disease remains low, limiting our understanding of treatment benefits and side effects.

Despite incremental progress over the past few decades, patient participation is still not aligned with the heterogeneity of intended treatment populations. But new regulatory initiatives and guidance, such as the Consolidated Appropriations Act, which requires diversity action plans for Phase 3 trials, and the FDA’s 2022 Diversity Plans Guidance, which reinforces the need to set informed diversity goals, have increased sponsors’ pressure to focus on diversity initiatives. Furthermore, recent ICH E8 Guidance provides international recognition of the need for diversity, emphasizing that studies in later stages of drug development include participants who represent the diverse populations receiving interventions in clinical practice. 

Key Barriers to Achieving Diversity in Clinical Trials

Several pertinent barriers have impeded diversity in clinical studies.

Implementation Factors

Clinical programs often do not focus on diversity until execution fails to meet expectations. Critical perspectives can be overlooked without input from various stakeholders (e.g., patients, sites, and caregivers) during the initial design phase, resulting in plans lacking key success elements. For example, the failure to allocate funds to enable site engagement with underserved communities can lead to operational challenges that could be averted with consideration earlier in the planning process. 

Patient Access and Awareness

Lack of clinical trial awareness and education poses a significant challenge, alongside cultural/language barriers, provider mistrust, and negative attitudes toward research, particularly from ethnically minoritized populations due to past injustices. The high burden of participation, along with geographic and economic factors, also plays a role. 

Infrastructure Challenges

This tends to affect minoritized populations disproportionately. For instance, community-based health centers frequently lack appropriate research infrastructure, incentives, training, and technology. There is a need to partner with, empower, and invest in sites to enhance their capabilities. 

Attempts to improve diversity in clinical trials through guidance alone have yet to succeed, evidently requiring a multifaceted approach involving all stakeholders. 

While the FDA began releasing guidance on race, ethnicity, and diversity plans in 2012, recent granular analysis of US trials over the last decade highlights specific indications where black patient enrollment does not reflect real-world population estimates (14.6%). The enrollment gap is significant in Alzheimer’s (5%) and Lung Cancer (8.1%) trials, disease areas that disproportionately impact Black Americans, demonstrating the continued disparity.

Trial Stakeholder Engagement Is Key to Achieve Diversity in Clinical Trials

Tackling clinical trial diversity requires proactively incorporating all stakeholders' perspectives into trial designs that consider diversity goals, site empowerment, and “high-touch” patient engagement. Recently, regulators, sponsors, CROs, sites, industry associations, tech companies, and advocates have launched various initiatives, reflecting the expanding urgency and pressure around this issue. 

Each stakeholder can employ key strategies to enhance clinical trial diversity as follows.

Sponsors and CROs

Sponsors and CROs can prioritize trial designs that create more welcoming experiences for all patients. This includes selecting study sites that are trusted by underrepresented communities, empowering local doctors to serve their community as new clinical research sites, and/or taking a data-driven approach to identify sites that have historically been successful at recruiting more diverse patients. Furthermore, sponsors can foster improved communication and trust by empowering patients with insights and outcomes after the trial. 

A recent study revealed most Black patients were enrolled by only 10% of US study sites when participating in Alzheimer’s, migraine, lung cancer, and breast cancer trials, underscoring the importance of factoring in patient preference during the planning phase.

Patients

Patient advocates can aid progress by helping build community partnerships and engagements to increase patient trust in research, raising awareness of opportunities, and easing barriers to access. Furthermore, they can actively provide input throughout trial planning so more patient perspectives can be represented from design through recruitment. 

Sites

Enhancing community health infrastructure enables support for expanded patient populations. Cultural and language literacy initiatives effectively foster community engagement while providing sites with access to technology and associated training promotes equitable recruitment and retention among minority groups.

A holistic strategy, informed by stakeholder collaboration, can help address the industry’s persistent diversity issue. Progress will also hinge on better guidance and incentives for prioritization by sites, researchers, and sponsors. 

Leverage the Right Technology to Achieve Diversity Goals in Clinical Trials

Technology adoption can accelerate diversity efforts by fostering connectivity, trust, and accessibility while offering sponsors and CROs data-driven insights to maximize the participation and engagement of diverse populations.

Deploying the right technologies can help create a comprehensive approach to diversity by:

• Establishing realistic goals to inform diversity action plans using standardized, historical clinical trial data for performance benchmarking
• Identifying high-performing sites by leveraging operational performance insights to meet enrollment objectives
• Providing a flexible, welcoming experience for all patients, accommodating those who find travel burdensome, and enabling pre-trial engagement by incorporating decentralized clinical trial (DCT) technologies
• Expanding access to trial opportunities to all potential participants, while expediting recruitment timelines using patient registries and pre-screening technologies

Summary

Successful clinical trial diversity initiatives require a strategic commitment and comprehensive stakeholder involvement. Implementing innovative clinical trial technologies through a holistic, multi-faceted approach can enhance each stakeholder's contribution, improve diversity outcomes, and, ultimately, expand access to novel therapies for the broadest range of patients.

Download the Medidata Diversity Program eBook to get started with best practices for building diversity into every step of your clinical trial: