Equal opportunity to healthcare is not just a topic of discussion — it must be intentionally implemented and built into every aspect of healthcare. In clinical research, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products.

Patient Engagement Specialist,
Premier Research

Vice President, Global Head of
Medical Affairs, Premier Research
In this Xtalks Spotlight edition, two experts from Premier Research — Dr. Sarah Cross, Vice President and Global Head of Medical Affairs, and Beatrice Doe-Printemps, Patient Engagement Specialist — discussed the significance of diversity, equity, and inclusion (DEI) in clinical research. They shared insights into the steps regulatory bodies are taking to advance DEI and how clinical research organizations (CROs), in partnership with key stakeholders, are evolving trial design and operational strategies to support these initiatives.
The Importance of DEI in Clinical Research
DEI is critical in clinical research to ensure all populations, especially those historically underrepresented, have access to safe and effective treatments.
“If we don’t consider the unique needs of various communities, we risk perpetuating health disparities and excluding certain groups from medical advancements.”
— Beatrice Doe-Printemps
Historically, clinical trials have disproportionately excluded women, people of color and other marginalized groups, leading to results that may not be generalizable to the broader population. This lack of diversity can result in treatments that do not account for genetic, environmental, or social factors affecting these groups, ultimately perpetuating health inequities.
By addressing these gaps, clinical research can ensure that the resulting medical advancements are safer, more effective and accessible to everyone, improving outcomes across diverse populations.
Barriers to Participation in Clinical Trials
Doe-Printemps highlighted several key barriers faced by underrepresented populations, including:
- Distrust: Historical events, such as the Tuskegee syphilis study and the unauthorized use of Henrietta Lacks’ HeLa cells, have fostered distrust in the medical community. This distrust is further compounded by a lack of visible accountability and representation in the research process.
- Access to information: Limited resources and educational materials hinder informed decision-making about trial participation. Many individuals in underserved communities lack access to clear, culturally relevant information about the purpose and benefits of clinical trials.
- Logistical challenges: Transportation, childcare and work or family commitments often prevent participation. Additionally, participants may face financial burdens or geographic barriers that make it challenging to attend trial sites.
- Healthcare system navigation: For many, navigating the healthcare system and understanding how to access clinical trials can be a daunting task, especially for those without advocates or support networks to guide them.
Addressing these barriers requires transparency, education and community engagement. Doe-Printemps emphasized the importance of culturally competent recruitment strategies, multilingual resources and logistical support, such as flexible hours and decentralized trials.
Furthermore, creating community partnerships and empowering local organizations to act as liaisons can foster trust and awareness, encouraging more equitable participation.
Regulatory Guidance to Advance DEI
The FDA’s 2024 draft guidance on clinical trial diversity highlights the need for racial and ethnic diversity action plans, particularly for later-stage studies. While these plans primarily target late-phase trials, their integration across the entire asset development lifecycle is essential to ensure representative data is collected at every stage.
“Early-phase studies are crucial for understanding safety outcomes and dosing regimens,” emphasized Dr. Cross. “If we don’t put these diversity plans in place early on, we’re losing a really rich component to help inform on the overall development of that asset.”
Collaboration is a key component of successful implementation. Engaging sponsors, patient advocacy groups and community organizations ensure that diversity plans are not only implemented but also customized to address the unique needs of underrepresented populations. Regular monitoring and transparent reporting of diversity and inclusion metrics are also critical to measuring progress and fostering accountability among stakeholders.
Historical exclusions provide a stark reminder of the importance of these measures. For instance, women of childbearing age were excluded from participation in early phase clinical trials in 1977. The exclusion was applied more broadly to medical research resulting in significant gaps in gender-specific data, and it wasn’t until 1993 that US Congress passed a law requiring inclusion of women in clinical research. This exclusionary policy, driven by a protectionist mindset, deprived the medical community of valuable insights into treatment effects across genders. Today, regulatory frameworks are evolving to correct such past oversights by prioritizing inclusivity and diverse representation.
The ongoing evolution of regulatory guidance, informed by past lessons and current needs, is vital to advancing DEI. Advocacy and continuous refinement of policies will ensure that regulatory frameworks keep pace with the changing healthcare landscape and the diverse needs of patient populations.
Evolving Trial Design and Operational Strategies
Trial design and operational strategies must evolve to support DEI throughout the product lifecycle. Effective strategies include:
- Inclusive protocol design: Engaging patient voices early in the development process helps create protocols that are inclusive of diverse populations. This ensures that eligibility criteria and study procedures do not inadvertently exclude key demographics.
- Reducing barriers: Incorporating decentralized trial components, such as virtual visits and wearable technology, can alleviate logistical challenges. These measures make it easier for participants to engage in trials, especially those in rural or underserved areas.
- Site selection and training: Identifying trial sites within underrepresented communities and ensuring site staff receive cultural competency training can significantly improve outreach and engagement efforts.
- Community engagement: Building partnerships with local organizations and patient advocacy groups fosters trust and encourages participation. Engaging directly with communities to address their unique concerns and needs can also improve recruitment and retention rates.
By implementing these strategies, clinical trials can become more accessible and equitable, ensuring that research outcomes benefit the full spectrum of patient populations.
The Role of CROs in Shaping DEI
CROs are uniquely positioned to drive change in clinical research by fostering partnerships with sponsors, patient advocacy groups, and site networks to establish sustainable DEI frameworks. These collaborations align research goals with community needs and regulatory expectations.
Elevating the patient voice is a crucial aspect of their role. By incorporating feedback from diverse populations, CROs can ensure that study designs are inclusive and patient-centered, reducing barriers to enrollment and increasing representation in clinical trials.
CROs also contribute to industry initiatives such as REFLECTIONS (bereflected.org), an independent, grassroots collective uniting stakeholders to sustainably improve trial diversity and support access to clinical research participation.
“CROs play a critical role in shaping the future of DEI in clinical research by leaning in on regulatory guidance, D&I framework, and fostering partnerships to create sustainable programs that improve clinical trial representation.”
— Sarah Cross
Building trust within communities is another significant responsibility for CROs. Through culturally competent strategies and close collaboration with local organizations, CROs can address historical barriers and encourage greater participation from underrepresented groups. This trust-building not only facilitates better trial outcomes but also helps reshape the clinical research landscape to be more equitable and inclusive.
As Doe-Printemps said, “By integrating DEI into their operations, CROs can ensure clinical trials are not only compliant but also actively promote inclusion, setting a new standard for equitable participation.”
The healthcare industry has made strides in promoting DEI, but there is still much work to be done. CROs, sponsors, and regulatory bodies must continue to collaborate, innovate, and prioritize inclusivity at every stage of the clinical trial process.
Committing to DEI ensures that clinical research advances health equity, improves outcomes, and benefits all communities.
This article was created in collaboration with the sponsoring company and the Xtalks editorial team.
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