Equity in Healthcare | The Acclinate Blog

Designing Research for Underrepresented Patient Populations

Written by Acclinate | December 31, 2025

Key Takeaways

  • Inclusive research design starts with intentionality—diversity doesn’t happen by accident.
  • Co-creating studies with community leaders builds trust, accessibility, and cultural relevance.
  • Flexible, participant-centered trial formats make research more inclusive for underrepresented patient populations.
  • Get on the path to more inclusive clinical research with our comprehensive guide to advancing health equity.

Historically, most clinical trials haven’t been built with underrepresented people in mind—and that shows in the data. For decades, systemic barriers have limited who participates in studies, which means findings haven't always reflected the full diversity of real-world populations.

The damage this gap between study results and lived experience has caused is two-fold: entire communities have been excluded from health advancements, while the future of medical research has been stifled by siloed data.

Let's explore how inclusive design, co-creation with community leaders, and flexible trial formats can better support underrepresented patient populations and clinical studies—and how Acclinate is helping reshape research around the people it has historically overlooked.

Why Research Has Historically Overlooked Underrepresented Patient Populations

Traditional research methods often exclude people unintentionally through strict eligibility criteria, site locations, or study designs that don’t consider cultural or logistical barriers. Eligibility requirements can screen out older adults, individuals with comorbidities, or those living far from research centers. Meanwhile, complex protocols, rigid visit schedules, and mistrust rooted in past abuses all contribute to low participation among marginalized communities.

The result is a body of research that, while rigorous, often fails to represent the full human picture. Data gaps translate into treatment gaps, which perpetuate inequities. As the National Institutes of Health notes, diverse participation is essential to ensure that medical advances benefit everyone—not just those easiest to reach.

Principles of Inclusive Trial Design

Designing for inclusion begins long before recruitment starts. It requires a shift from “How do we get people to join?” to “How can we design research that welcomes everyone in the first place?”

1. Inclusive Eligibility and Representation

Trials should reflect the complexity of real-world patients. Rather than narrowing eligibility to the “ideal participant,” researchers can adapt criteria to include diverse ages, comorbidities, and social contexts. Expanding eligibility improves both representation and external validity.

2. Co-Creation With Community Leaders

True inclusion requires collaboration. Partnering with community leaders, faith organizations, and advocacy groups ensures that research reflects the needs, values, and voices of the populations it aims to serve. This co-creation approach moves beyond token consultation—it gives communities agency in shaping study design, outreach, and communication.

3. Flexible, Participant-Centered Trial Formats

Rigid, site-based studies can exclude those who face transportation, childcare, or work challenges. Hybrid and decentralized models—combining in-person and remote elements—allow participants to engage on their terms. These approaches expand access while maintaining data integrity.

4. Cultural Responsiveness and Empathy

Inclusive design also means designing with empathy. Materials should be linguistically and culturally relevant, recruitment should acknowledge historical mistrust, and data use should be transparent. As Acclinate UX designer Apurva Chinta wrote in Designing for Empathy: Creating Accessible Tech with a Human Touch, technology and research alike must “meet people where they are” to foster genuine connection.

5. Continuous Feedback and Accountability

Diversity isn’t simply a goal, but a commitment to measure and improve over time. Building feedback loops into studies ensures ongoing communication and accountability, showing participants how their involvement shapes outcomes.

How Acclinate Helps Reshape Research Around People Historically Overlooked

At Acclinate, inclusion is built into our design philosophy. Our approach integrates data, systems, and human connection:

  • Co-Design with communities: We collaborate with local organizations and trusted messengers to create outreach materials, educational resources, and retention strategies that resonate with specific populations.
  • Data-driven representation: Through e-DICT™ analytics, we identify underrepresented patient populations, uncover enrollment gaps, and guide site selection for better demographic balance.
  • Trusted engagement channels: Our NOWINCLUDED community platform connects more than 170,000 members who share experiences, access trusted health information, and engage in research opportunities with transparency and respect.
  • Culturally grounded practices: Every touchpoint—from consent forms to digital messaging—is built to honor the lived experiences of diverse participants.

This model advances inclusion from aspiration to action, helping sponsors design studies that reflect the people most impacted by their outcomes.

The Business and Scientific Case for Inclusive Research

Inclusive research design isn’t just ethical—it’s practical. Studies that include diverse populations produce data that’s more reliable, generalizable, and market-ready. Sponsors benefit from faster enrollment, fewer protocol deviations, and improved retention rates when trials align with participants’ realities.

Regulatory bodies are taking note: the FDA now requires Diversity Action Plans outlining how sponsors will recruit and retain participants from underrepresented groups. Meeting these expectations means embedding inclusion into design, not adding it at the end.

Ultimately, inclusive design delivers better science. When more people see themselves represented in research, trust grows, engagement increases, and healthcare outcomes improve for everyone.

Moving From Design to Practice

To operationalize inclusive design:

  • Review your current protocols. Identify eligibility or logistical barriers that may exclude certain groups.
  • Engage communities early. Build partnerships before protocol finalization, not after.
  • Leverage hybrid models. Integrate telehealth, mobile units, or remote monitoring to expand reach.
  • Track inclusion metrics. Use demographic data to monitor progress and course-correct as needed.
  • Invest in empathy. Train research teams to understand cultural nuance and communicate with transparency.

These actions help transform research from an extractive process to a collaborative one—rooted in respect, trust, and shared benefit.

The Future of Research Is Inclusive by Design

The path to equity starts long before recruitment—it begins at the design table. By involving communities early, embedding empathy into every touchpoint, and embracing flexible trial models, we can create a research ecosystem that truly reflects the diversity of the world it seeks to serve.

At Acclinate, we’re committed to helping sponsors lead that change—so every discovery moves us closer to a future where research represents all of us.

Want a closer look at how we approach inclusive research? Schedule a 1:1 with our team.