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Health equity isn’t just an outcome. It’s a process that sets the foundation for inclusive, impactful clinical research. And it requires significant, targeted initiatives enacted upstream from the recruitment process.
For decades, underrepresented communities have faced barriers to accessing healthcare, including financial constraints, geographic limitations, and institutional mistrust rooted in historical marginalization and structural bias. These factors contribute to a stark lack of representation in clinical research, leading to treatments that may not be as effective or safe for all populations.
Ensuring that trials reflect the patient populations they aim to serve is essential to advancing medical knowledge, improving patient outcomes, and fostering trust in research.
By prioritizing community engagement, equitable access to care, and early investment in representative research methodologies, clinical trial sponsors can create an environment where health equity is not an afterthought but an integral part of the research process. Here, we explore the critical role of health equity in clinical research, the systemic barriers that must be addressed, and innovative solutions that are transforming the future of inclusive healthcare.
The work of building health equity begins before recruitment—it starts with acknowledging the gaps, engaging communities meaningfully, and committing to sustainable, long-term change in the way clinical trials are designed and conducted.
Chapter 1
What is health equity? Health equity ensures everyone has a fair opportunity to achieve optimal health by addressing systemic barriers such as economic disparities, discrimination, and lack of access to care. That’s the key difference between health equity vs health equality, which provides the same resources to everyone. Health equity recognizes that different populations need tailored solutions to achieve similar health outcomes.
Social Determinants of Health (SDOH): Education, income, and environment impact health outcomes.
Access to Quality Healthcare: Removing financial, geographic, and cultural barriers is crucial.
Community Engagement: Partnering and building Affective Trust with underrepresented groups ensures research reflects their needs.
Representative participation in clinical trials leads to findings that apply to broader populations and supports better personalized medicine research. For example, Albuterol, a common asthma medication, is less effective in Black and Puerto Rican patients, illustrating the need for more equitable research.
Equitable clinical trials strengthen data integrity and validity. By including representative populations, researchers reduce bias and improve the reliability of their findings. In this way, not only is better representation better for people. It’s better for science.
Clinical research can uncover disparities in disease progression, treatment efficacy, and access to care, guiding targeted interventions to improve health outcomes. For example, Black mothers are 2.6 times more likely to die during pregnancy from complications than their white counterparts. Additionally, non-Hispanic Black Americans tend to be diagnosed with hypertension more frequently and earlier in life.
Black mothers are
2.6x
more likely to die during pregnancy from complicaitons than their white counterparts.
Historical mistreatment in medical research has led to mistrust among certain communities. Ethical, community-centered research fosters transparency and trust.
Regulatory bodies increasingly require equitable representation in clinical trials. Meeting these standards early prevents delays and ensures compliance.
Health equity is critical for ensuring all communities have access to high-quality healthcare. However, underrepresented communities often face systemic barriers, including economic disadvantages, limited healthcare access, and implicit bias in treatment. These factors contribute to higher rates of chronic diseases and lower life expectancy in communities of color.
The U.S. Department of Health and Human Services identifies five key social determinants of health:
Economic Stability
The racial wealth gap affects access to healthcare and opportunities for well-being.
Education Access & Quality
Limited educational opportunities impact health literacy and healthcare decision-making.
Healthcare Access & Quality
Geographic and financial barriers prevent many from seeking preventive and necessary care.
Neighborhood & Built Environment
Environmental factors, including pollution and unsafe housing, contribute to poor health outcomes.
Social & Community Context
Experiences of discrimination and bias impact mental and physical health.
The lack of representative participation in clinical trials remains a significant challenge. A recent report found that representation in U.S. clinical trials fell 46% from 2018 to 2022, underscoring the need for targeted engagement and recruitment strategies. Underrepresentation in research leads to inequitable healthcare solutions, with treatments often tested on a narrow demographic and failing to address the unique needs of broader populations.
Advancing Health Equity Through Research
To ensure equitable health outcomes, researchers and healthcare leaders must:
Engage with underrepresented communities through trust-building initiatives.
Remove barriers to trial participation, such as transportation and financial challenges.
Improve community-centered recruitment strategies that acknowledge cultural and historical contexts.
Chapter 2
Traditional clinical recruitment methods have historically failed to attract representative participant pools. In 2020, 75% of clinical trial participants were White, highlighting the stark underrepresentation of communities of color. These barriers to recruitment in clinical trials must be addressed to ensure that medical advancements serve all populations equally.
Mistrust in the healthcare system: Historical injustices, such as the Tuskegee Syphilis Study, have left a legacy of skepticism among underrepresented communities, limiting participation in trials.
Limited accessibility: Many clinical trials are conducted at specialized centers that are not easily accessible for rural or low-income participants.
Lack of awareness: Many individuals from underrepresented groups remain unaware of clinical trial recruitment processes, reducing participation rates.
To counteract these barriers, clinical research sponsors must:
Establish targeted outreach programs to educate underrepresented communities.
Strategically place clinical trial sites in accessible locations.
Provide transportation and logistical support to encourage participation.
Build trust through community partnerships to foster engagement.
By implementing these strategies, the challenges in recruitment and retention of clinical trial subjects can be mitigated, ensuring that clinical recruitment becomes more inclusive and representative of all populations.
More than 80% of patients are unaware of clinical trials or don’t know how to participate in them. Physicians often fail to discuss trials with underrepresented patients due to implicit bias. This is a missed opportunity, as studies show that willingness to participate is similar across racial and ethnic groups.
Historical medical abuses, from the Tuskegee Syphilis Study to modern examples like disparities in maternal healthcare, have fostered skepticism. This leads to a lack of engagement with clinical trial recruitment companies, as underrepresented groups often assume trials won’t benefit them.
When potential participants from underrepresented communities express interest, they often see marketing materials featuring white patients or interactions with staff who don’t reflect their backgrounds. This creates an immediate disconnect. Working with trusted community-based organizations, such as NOWINCLUDED, can help bridge this gap.
Patient recruitment in clinical trials is hindered by trial sites located far from the communities sponsors aim to reach. Transportation difficulties and inflexible scheduling discourage participation. More intentional site selection can mitigate these barriers.
Engaging with local organizations and leaders can significantly improve recruitment efforts. Sponsors who fail to build strong community partnerships miss out on the trust and rapport needed to recruit effectively from underrepresented populations.
Even when participants enroll, many drop out due to logistical issues, lack of communication, and inadequate support services. Providing transportation, reminders, and responsive study coordinators can improve retention rates.
Many clinical trial recruitment companies lack clear representation goals. Without measurable targets and accountability mechanisms, progress remains slow. Establishing benchmarks for underrepresented populations is crucial for improving inclusion.
The biggest barrier to participation is distrust. Clinical research recruitment agencies struggle to enroll underrepresented patients who lack trust in trial sponsors and healthcare institutions.
Successful clinical research recruitment strategies emphasize affective trust, which prioritizes emotional connections and shared values. This requires transparent communication about trial goals and partnerships with trusted community organizations.
By engaging communities through platforms like NOWINCLUDED and leveraging e-DICT analytics, clinical researchers can improve participation and retention.
The key benefits include:
Creating more representative studies.
Expanding access for underrepresented populations.
Meeting federal representation targets.
Promoting health equity in clinical research.
Developing treatments that serve all patient populations.
Acclinate bridges gaps across the care continuum through a people-first approach and AI-powered analytics, ensuring clinical trials reach and engage underrepresented communities effectively and genuinely. By fostering affective trust through NOWINCLUDED and leveraging the predictive insights of e-DICT, trial sponsors can develop equitable practices that lead to more inclusive and effective clinical research initiatives.
Back to TopChapter 3
One of the biggest flaws in traditional clinical recruitment is focusing solely on trial enrollment rather than fostering long-term community connections. Joanice Thompson, Acclinate’s former Adviser for Community Engagement and Partnership Building, emphasizes that building trust before recruitment begins is essential to improving health equity.
Many recruitment strategies rely on short-term outreach—what Thompson describes as “putting up a banner” in a community, enrolling patients, and then leaving. This approach fails to address deeply rooted mistrust of the medical system, particularly among historically underrepresented populations.
Thompson highlights Acclinate’s approach as a model for meaningful engagement: “We’re not just asking for participation—we’re educating communities first.” The NOWINCLUDED platform enables authentic dialogue on healthcare topics, creating a foundation of trust before clinical trial discussions even begin.
According to a 2023 Journal of Clinical and Translational Science review, only a fraction of community engagement efforts focus on co-leadership or sustained collaboration. Most initiatives emphasize consultation but fail to involve communities in meaningful ways.
Thompson argues that how to promote health equity starts with listening: “It’s not about a one-time event—it’s about ongoing relationships.” Building trust requires sustained communication and partnership, not just education.
Patient recruitment strategies that build lasting connections and prioritize health equity require more than advertising.
Acclinate applies its Affective Trust Framework by collaborating with grassroots organizations to engage communities where they already are. This allows research initiatives to engage individuals in environments where they feel safe and heard, improving long-term retention.
Thompson describes storytelling as a vital engagement tool: “People relate to personal stories more than medical jargon.” By amplifying real patient experiences through NOWINCLUDED, Acclinate empowers “message carriers”—community members who organically share knowledge about clinical trials.
Clinical trial sponsors face numerous obstacles when engaging communities of color, from historical mistrust to transportation and access barriers. However, by learning key lessons from examples of health equity, sponsors can create more inclusive research frameworks.
Over 18,000 individuals engaged with maternal health resources, with 45% indicating willingness to participate in clinical research.
In just over a year, Acclinate reached more than 1.5M community members, leading to 200+ completed pre-screeners for IBD research.
A virtual CRO pre-screened 164 representative participants in four months—nearly 4x the previous year’s total.
The Multiple Myeloma Research Foundation (MMRF) partnered with Acclinate to increase awareness and participation among communities of color in multiple myeloma research opportunities across Atlanta, Detroit, Philadelphia, and Birmingham.
A CRO leveraged NOWINCLUDED and targeted digital outreach to enroll 27 non-White participants in an RSV vaccine trial within two months.
18K+
engaged with maternal health resources
1.5M+
community members reached
4x
previous year's total pre-screened
27
non-White participants enrolled
Chapter 4
AI and data-driven technologies are transforming healthcare, offering new ways to advance health equity solutions. A Bain & Co. survey found AI adoption in health systems has tripled, with over 70% optimistic about its impact. One overlooked use case is AI’s ability to predict clinical trial engagement, helping sponsors recruit more representative participants faster.
Representation gaps in clinical trials persist, delaying approvals and limiting access to new therapies. Measuring health equity with AI-powered platforms like e-DICT helps identify participation barriers, from broadband access issues to transportation challenges, allowing sponsors to develop targeted recruitment strategies.
Sponsors can integrate digital health equity solutions to improve outreach and engagement by:
Pre-screening potential participants based on inclusion criteria.
Identifying geographic and socioeconomic barriers to enrollment.
Tracking outreach effectiveness to refine strategies in real time.
By anticipating recruitment challenges, sponsors can refine trial design early, improving representation and retention rates.
AI-driven insights alone aren’t enough—genuine community engagement is crucial for overcoming trust barriers. Acclinate’s NOWINCLUDED platform strengthens health equity solutions by fostering trusted connections with underrepresented communities.
Founded in 2020, Acclinate has been dedicated to advancing health equity and empowering communities to take actions for better health by integrating sustained community engagement with predictive analytics. Co-Founders Del Smith, Ph.D., and Tiffany Whitlow established Acclinate to ensure clinical trials are inclusive, representative, and accessible to underrepresented communities.
In May 2024, Acclinate secured
$7M
in Series A funding.
In May 2024, Acclinate secured $7 million in Series A funding, following partnerships with Merck and other industry leaders to improve Black American participation in oncology trials. Their work has led to major industry recognition, highlighting their commitment to health equity initiatives.
Smith’s personal experience—discovering a family history of early cancer deaths—motivated his mission to break generational health barriers. Similarly, Whitlow’s journey navigating asthma treatment challenges for her son underscored the urgent need for representative drug trials. Their combined efforts have transformed clinical research patient engagement by addressing historical mistrust and fostering affective trust with communities of color.
Recognition for Innovation in Health Equity
Acclinate’s tech-and-touch model has earned widespread recognition:
Acclinate made the Inc. 5000. Tiffany Whitlow was also named a Top 250 Female Founder.
NOWINCLUDED won Silver at the Anthem Awards for contributions to community engagement and health equity.
DPharm Idol Disrupt 2022 Winner, acknowledged as a “high-value, timely solution” for improving clinical trial representation.
Recognized among the Best Workplaces for Innovators by Fast Company.
Cox Enterprises Social Impact Accelerator Alum, reinforcing Acclinate’s commitment to healthcare equity.
Additionally, Acclinate has built partnerships with organizations such as Lightship and Savvy Cooperative expanding the reach of health equity initiatives.
Measurable Impact on Clinical Trial Representation
Building health equity in clinical research is not just about improving recruitment—it’s about reshaping the entire research process to ensure representation, inclusion, and accessibility at every stage. By addressing systemic barriers before recruitment begins, clinical trial sponsors can create research environments that foster trust, encourage participation, and lead to more effective and equitable care.
The data is clear: without representative clinical trials, treatments will not be as safe or effective for all populations, and disparities in healthcare outcomes will persist. Tackling issues such as social determinants of health, historical mistrust, and lack of access to quality care requires a proactive approach—one that integrates community engagement, innovative recruitment strategies, and data-driven insights from the outset.
Acclinate is leading the way in bridging clinical trial gaps by using sustained community engagement and AI-powered analytics to build trust and improve participation in research opportunities. As the healthcare industry continues evolving, sponsors, researchers, and policymakers should commit to prioritizing health equity as a foundational principle—not an afterthought.
By making health equity the standard in clinical research, we move closer to a future where medical advancements benefit everyone—regardless of race, ethnicity, socioeconomic status, or geographic location. The path forward requires action, accountability, and long-term investment in solutions that drive real, measurable change.
Ready to learn why Acclinate is the partner of choice for advancing representation across healthcare? Schedule a consultation with our team.
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