How Incyte Is Advancing Clinical Trial Diversity

Leveraging Data for More Inclusive Research

Diversity in clinical trials is more than just a regulatory requirement—it’s a critical component of equitable healthcare. Ensuring that trial participants reflect the real-world patient population leads to more effective treatments and better health outcomes. At Incyte, a structured, data-driven approach has become the foundation for improving representation in clinical trials.

In a recent discussion, Dija Atta, Head of Regional Clinical Operations, and Stacy Eckstein, Manager of Global Trial Informatics, shared how Incyte is taking meaningful steps toward more inclusive research. From launching internal initiatives to leveraging internal data and real-world data, their team is setting new standards for trial diversity.

Building a Framework for Diversity in Clinical Trials

A key first step for Incyte was the formation of a committee designed to create lasting change by ensuring that underrepresented patients have better access to clinical research.

Rather than jumping into quick-fix solutions, Incyte focused on assessment and education first—assessing the organization’s knowledge of the FDA’s requirements through interviews and global surveys and then building a foundational understanding of trial diversity across the organization through the first-ever clinical trial diversity planning training series. From there, the team created a structured roadmap that included epidemiological research, an assessment of patient participation barriers, and expert consultations.

“We established a roadmap to be able to do that, and foundational to that roadmap is really epidemiological understanding—your incidence, your prevalence, who actually is underrepresented by the literature, and what a representative study looks like,” Dija shared.

A second thing that the team did was they really focused on sites—understanding participation barriers to accessing trials. And they also consulted with some external experts who helped them understand that and put plans in place to address it.

Using Data to Drive Site Selection and Feasibility

Incyte has embraced a data-first approach to site selection, leveraging both internal and external data sources to identify clinical trial sites that have access to diverse patient populations. This strategy allows their team to move beyond assumptions and instead make informed decisions about where and how to conduct trials.

“I rely heavily on internal and external data to objectively identify sites that have access to diverse patient populations. So having the information allows my team to support the study teams with the necessary information needed to be able to draft their diversity plans. This is a key step on the diversity roadmap,” Stacy explained.

Additionally, Incyte has developed an internal diversity patient enrollment dashboard, which allows real-time tracking of patient demographics across its clinical trial portfolio. This level of insight enables the team to monitor progress and adjust strategies in real time, ensuring that enrollment targets align with diversity plans.

Real-World Data: A Game Changer in Global Feasibility

By integrating real-world data (RWD) into their site feasibility assessments, Incyte has gained a deeper understanding of where disparities exist and how to address them effectively. Stacy described the different data sources that contribute to this process:

“We have access to patient data, site data, and real-world data. So when I think of site data, I think about our internal site performance data, our internal quality data, and of course, the responses that we receive from our feasibility questionnaires. When I think about real-world data, I think about indication-specific diversity data, claims data, social determinants of health data, and epidemiology data,” she explained.

These datasets work together to provide a comprehensive picture of potential trial sites, ensuring that Incyte selects locations that best reflect the target patient population.

Reshaping Site Identification for Phase 3 Trials

One of the most significant benefits of integrating diversity data into trial planning has been its impact on Phase 3 trial site selection. Stacy shared how their team revisits their Phase 2 trial footprint and uses new insights to refine their Phase 3 strategy.

“One thing that I love doing is creating a site coverage map. At the time that the Phase 2 study was going on, let’s say they didn’t have access to claims data and diversity data, but now that we have access, we can reassess using our diverse insights to look at how we can redefine the Phase 3 strategy,” Stacy said.

By overlaying claims data and diversity data, they can identify gaps in trial coverage and adjust accordingly. “For example, if we look at the claims data and notice that we haven’t gone to a particular state or a particular city, seeing this new data can now inform the decisions to make those moves and those strategies in the Phase 3 program,” Stacy added.

Filling Geographic Gaps to Improve Representation

A critical part of Incyte’s diversity strategy is ensuring clinical trials are conducted in locations that represent the full spectrum of patient populations. By analyzing geographic data and diversity insights, they can identify underrepresented areas and take corrective action.

“It could be net new. It could just be new states in general,” Stacy said. “One time we did this activity and realized we didn’t have any sites in Illinois or New York. So even if we’re using our same providers, we make sure that we fill in the gaps by placing sites in those areas.”

This data-driven approach ensures greater inclusivity and aligns Incyte’s trial planning with the real-world distribution of patients.

A Passionate Commitment to Lasting Change

While data and technology have been instrumental in advancing clinical trial diversity at Incyte, real change requires dedication. Stacy acknowledged that improving representation in clinical trials is a long-term effort that demands persistence.

“As it relates to clinical trial diversity, it’s not for the faint of heart.” Stacy goes on to say, “it’s a work of passion and dedication, and it’s a fight that continues to be fought. Identifying sites that have access to patient participants is just one of the many facets that are involved when it comes to moving the needle in clinical trial diversity,” she said.

Looking Ahead: The Future of Diversity in Clinical Trials

Incyte’s commitment to diversity in clinical trials is based on education, strategy, and data-driven decision-making. Through patient representation initiatives, real-time tracking dashboards, and comprehensive data analysis, Incyte continues to set new industry standards for inclusive research.

By leveraging technology, expanding its site footprint to include locations that serve underrepresented patient populations, and maintaining a deep commitment to equitable representation, Incyte is not just meeting regulatory expectations—they are reshaping the future of clinical trials for the better.