How Can Clinical Research Teams Use Data-Driven Approaches to Foster Diversity in Research?

Ensuring that clinical trials represent diverse populations has become a necessity, not just a goal. Diversity in research goes beyond meeting quotas — it’s about achieving meaningful results that reflect the realities of those affected by a condition.

Inclusive trial design is not only an ethical imperative but also essential for developing treatments that are effective and relevant for all impacted individuals.

As Ryan Brown, Regional Vice President of Sales for Trial Landscape at H1, shared, “When organizations can align and galvanize around what diversity in clinical trials means, why it’s imperative for their organization and empower their team members with the right technology and tools to actually deploy, that’s where I’ve seen things just go really well.”

In this Xtalks Spotlight, we discussed the need for a holistic, data-driven approach to inclusivity with Ryan.

From using technology to identify underserved populations to reimagining traditional benchmarks, Ryan shared insights into strategies that make clinical research more representative and accessible for all.

Challenges to Diversity in Clinical Trials

According to Ryan, one of the main challenges to achieving diversity in clinical trials is the lack of alignment within organizations on the importance and meaning of diversity in research. She emphasized that success depends on organizations committing to a shared understanding of diversity and providing the right tools to make it a reality.

Ryan also highlighted the financial and logistical hurdles that sites face in recruiting diverse populations, often due to insufficient budgeting. “From a site perspective, it’s been incredibly challenging as well when things aren’t properly accounted for in the budget to reach underrepresented audiences,” she said. By using data to justify these budget needs, Ryan has found success in securing the necessary funding to implement new recruitment strategies.

Another challenge is the awareness gap among patients, many of whom are unaware that clinical trials may be a viable care option. For example, research shows that over 80 percent of Black women said that they would participate in a clinical trial if they were asked, challenging misconceptions that certain populations are less interested in participating. Addressing this awareness gap is key to making trials accessible to all who stand to benefit.

Using Social Determinants of Health Data

Incorporating SDOH into clinical trial design can enhance inclusivity by addressing the unique barriers that underrepresented groups face. Aggregating data on factors like income, education, language and environment provides a deeper understanding of the context in which potential participants live. Such SDOH data can help inform trial design and outreach strategies.

“The social determinants of health, they really help give that additional layer that helps us better serve the people we intend to reach.”

 

— Ryan Brown

For example, understanding participants’ work schedules and transportation limitations can reveal why certain groups may struggle to participate. In one case, Ryan explained that a trial targeting working women revealed that the “schedule of assessments and events is nearly impossible for these working women to make it in.” These insights can lead to adjustments that align study schedules more closely with participants’ availability, broadening access to the trial.

Language and cultural factors also play a crucial role in fostering inclusivity. Ryan shared how in one trial, an English-only inclusion requirement inadvertently excluded many Hispanic individuals affected by the disease.

“When you don’t allow for things like language to be considered, it automatically excludes those that are most impacted by the disease, and that could most benefit from the device or modality or intervention that we’re developing,” said Ryan.

By removing language barriers and incorporating culturally relevant materials, clinical teams can ensure trials are accessible and appealing to diverse populations.

Environmental factors, such as transportation and site location, are also critical considerations. Ryan emphasizes the importance of these logistical aspects, saying “When you don’t take those things into account, it creates additional burden and barriers that create a lot of bias in who gets to participate and who doesn’t.”

For instance, proximity to healthcare providers, transportation challenges and insurance coverage for standard-of-care procedures to qualify for a study are all real-world barriers that can impact trial participation. Addressing these factors helps make trials more inclusive and reduces logistical obstacles to participant involvement.

The Holistic Approach to Diversity

According to Ryan, a truly inclusive clinical trial design considers multiple dimensions of diversity, including race and ethnicity, and also factors like geography, gender, age and socioeconomic status. This holistic approach requires integrating diversity at every stage of the trial lifecycle, from initial design and site selection to participant recruitment and follow-up care.

It’s about creating a framework that acknowledges the varied realities of participants’ lives. As Ryan noted, “It’s an imperative that we think about people more than just race, more than just ethnicity, but think about where do people live, work and play.”

Embedding diversity from the outset of trial design means asking essential questions: Are study locations accessible to underrepresented populations? Do recruitment materials resonate with targeted communities? Does the study design accommodate participants’ logistical and cultural needs? By asking these questions early, researchers can prevent unnecessary exclusion and improve trial access for diverse populations.

Using technology and data analytics also plays a critical role in implementing a holistic approach. AI tools and predictive analytics can identify underrepresented populations who would benefit from targeted outreach, while electronic health records (EHRs), claims data and real-world evidence (RWE) help trial teams to better understand the local demographics and potential barriers of each site.

Importantly, this approach doesn’t stop when the trial ends. Post-trial support, follow-up care and accessible reporting of study outcomes are essential components of inclusive research. These elements ensure that participants continue to feel connected to the study’s goals and are not left out of the process.

The Role of Technology in Identifying and Supporting Diverse Populations

Technology is transforming the way clinical trials can reach and include diverse populations, moving beyond traditional data sources to create a comprehensive, real-time view of patient demographics.

According to Ryan, by tapping into platforms like H1, researchers can access insights from over 7,000 different data sources to pinpoint underserved communities. This approach allows for an in-depth analysis that goes far deeper than census data alone, helping researchers understand not only where potential participants are but also the healthcare providers who are already trusted within these communities. Ryan describes this technological capability as providing “a full snapshot of who might benefit,” which is invaluable for recruitment.

“Technology is a huge equalizer, especially when we can deploy it properly and also give the right supportive mechanisms to make technology enablement a reality for those that have historically been excluded.”

 

— Ryan Brown

Visual tools such as heat maps and zip-code level analyses further empower clinical trial teams to identify the geographic pockets most in need of representation. With these data visualizations, researchers can identify not just where patients affected by specific conditions live, but also the healthcare providers and institutions they trust. This precision allows trial teams to build recruitment strategies that are better aligned with community needs and tap into local networks to foster engagement and trust.

Mobile health technology is another key enabler in reaching underserved populations, especially those in rural or low-income areas where access to traditional healthcare facilities can be limited. The rise of wearables, remote monitoring devices and mobile apps enables decentralized clinical trials (DCTs), which allow participants to join studies from the comfort of their homes. With these tools, trial teams can collect real-time data on patient health metrics, reducing the need for frequent in-person visits. This not only lowers the logistical burden on participants but also broadens the trial’s reach, creating opportunities for individuals who may otherwise face barriers due to location or transportation issues.

By integrating advanced technologies, clinical trials can reach a broader spectrum of participants, generating results that are more reflective of real-world populations.

Example of Community Engagement and Clinical Trial Success

One powerful example of how data-driven, community-aligned approaches can transform clinical trials is highlighted in a case study on outreach to African American women for a metabolic disease trial.  

By collaborating with the community and engaging in culturally relevant ways, researchers achieved remarkable results: enrollment increased by 78 percent, and the study met its enrollment target 16 months ahead of schedule. This success was made possible through strategic partnerships with the community and alignment with the values of the African American patient population. 

The implications of such achievements are profound. What if similar culturally aligned, data-driven approaches were applied to other clinical trials? Could they consistently drive similar success?  

Achieving enrollment targets well ahead of schedule has the potential to make drug development more efficient. Reducing trial timelines by over a year could lead to earlier availability of life-saving treatments. This would benefit patients, accelerate organizational goals and foster far-reaching innovation across the healthcare industry. 

This case shows the role that meaningful community engagement and data-informed strategies play in addressing barriers to participation. Partnering with communities not only increases trial success rates but also fosters trust and inclusivity, ensuring that research outcomes are both equitable and impactful. 

Redefining Benchmarks to Prioritize Inclusivity

To achieve truly inclusive clinical trials, the industry must rethink its traditional benchmarks and evaluation criteria. The common reliance on past performance data and long-established partnerships with specific sites and investigators, while proven, often excludes newer sites and providers who serve diverse communities.

“For us to be disruptive, for us to do something new, it’s important that we reimagine how we evaluate what a good site looks like, what a good collaboration partner looks like,” said Ryan. By opening up opportunities for new providers — especially those with strong community ties — clinical research can become more accessible to underrepresented populations.

This reimagining of benchmarks also means considering criteria beyond a provider’s trial experience, such as their commitment to diversity, cultural competence and access to underserved patient populations. One way to achieve this is by setting concrete diversity goals and incentivizing sites to reach these targets, fostering accountability across sponsors, clinical research organizations (CROs) and site staff.

In addition, rather than focusing only on a site’s historical patient volume, trial teams can prioritize sites based on their connections with specific communities or their interest in trial diversity. A less-experienced investigator who is passionate about serving underrepresented groups and has access to the right resources and mentorship can bring a fresh, valuable perspective to the trial.

Encouraging diversity also means supporting these new sites with resources to succeed. This might involve mentoring partnerships with experienced investigators, increasing new investigator stipends to offset the costs of additional training on trial protocols as they shift their practice focus or offering logistical support for recruitment efforts. By investing in a more varied provider network, the industry can broaden its pool of potential trial participants and bring in perspectives that have historically been overlooked.

By adopting this holistic approach, clinical research teams can help close the gap in health equity, ensuring that treatments are not only accessible but also effective for all who need them.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.