As clinical trials evolve, one thing is certain: representativeness is no longer a nice-to-have; it’s a non-negotiable. The data are clear. In the 2025 TriNetX and studioID survey of 150 senior biopharma executives, 84% reported ramping up efforts to improve representativeness and accessibility in clinical research over the past few years. And nearly all (99%) plan to sustain or expand those efforts moving forward.
This isn’t a fleeting trend. It reflects an industry-wide recognition that equitable research is fundamental to trustworthy science, product acceptance, and better patient outcomes. But while the commitment to patient inclusivity is strong, translating that intent into action remains a challenge.
The Momentum Is Real, But So Are the Barriers
Many organizations are making meaningful progress. Nearly half of survey respondents strongly agreed their organizations have increased efforts around inclusion and representativeness in recent years. And 73% strongly agreed they plan to do even more in the coming years.
Yet despite the momentum, leaders also highlighted persistent, and in some cases growing, barriers to making trials more representative. Among the top challenges cited:
- Evolving regulatory trends (36%)
- Difficulties making trials accessible (34%)
- Niche patient populations (29%)
- Narrow site selection (21%)
- Constraints related to the availability of social determinants of health data (SDOH) (20%)
These issues aren’t new, and they’re becoming more urgent as organizations try to balance trial research needs, regulatory needs, patient burden, and accessibility.
Inclusion Is a Scientific Imperative
Representation in clinical trials isn’t just a matter of ethics or public perception; it’s a scientific imperative. When studies fail to reflect real-world populations, results may not clearly translate to broader patient groups. This lack of generalizability can slow adoption of new therapies, limit their effectiveness, and ultimately worsen health inequities.
Despite some regulatory uncertainty, most organizations recognize the value of inclusive research and aren’t waiting for mandates to act. There’s growing confidence that broad representation strengthens, not complicates, clinical evidence. The goal now is to move beyond aspiration to execution.
Real-World Data: A Catalyst for Inclusion
This is where real-world data (RWD) has a pivotal role to play. Derived from electronic health records (EHRs), health insurance claims, SDOH indicators, and even wearable devices, RWD brings critical visibility into target treatment populations.
By leveraging RWD, researchers and sponsors can:
- Identify underserved populations
- Understand participation barriers
- Pinpoint more inclusive trial sites
- Refine overly narrow eligibility criteria
For example, SDOH data can reveal that otherwise-eligible patients are more likely to live in multigenerational households, information that may prompt sponsors to rethink burdensome visit schedules or inconvenient trial locations. These are the types of insights that only deep, patient-level data can uncover.
Trial Complexity: A Hidden Barrier
While inclusion efforts are expanding, trial designs are becoming more complex. More procedures, more endpoints, and longer timelines can unintentionally exclude marginalized populations, even when eligibility criteria appear inclusive on paper.
RWD can identify these design friction points early; modeling how real patients navigate care and highlighting where protocols may fall short. Armed with these insights, sponsors can adjust before recruitment stalls or biases emerge.
Four Ways RWD Can Improve Trial Inclusion
Biopharma organizations now have the opportunity to put RWD to work across the trial lifecycle. Here are four practical strategies:
- Map the patient journey: Use longitudinal data to better understand current treatment patterns and identify barriers such as transportation, work schedules, or appointment adherence. Then, tailor protocols to reduce friction.
- Select inclusive sites: Move beyond traditional site selection. Choose trial sites based on patient diversity and community engagement, not just geographic convenience or past performance.
- Refine eligibility criteria: Use RWD to uncover when inclusion and exclusion criteria unintentionally leave out certain patient populations, resulting in trial cohorts that don’t accurately reflect the intended treatment population. By identifying these gaps early, RWD can help address them before they lead to trial issues or protocol amendments.
- Track and course-correct: Monitor recruitment representativeness against the target treatment population in real time and respond quickly when gaps emerge.
Inclusion Without Compromise
Some stakeholders worry that pushing for greater inclusion might slow research. But the opposite is true. With the right data infrastructure, sponsors can expand access while preserving scientific rigor.
True patient centricity means designing research around patients’ needs, preferences, and lived experiences. And to do that well, we need the most comprehensive dataset available, which is RWD.
A Measurable, Long-Term Commitment
The takeaway is clear: Inclusion is no longer just a regulatory checkbox or a corporate value; it’s a critical performance driver that can drive market adoption. It’s how we build better evidence, serve more patients, and bring new therapies to market that truly reflect the populations they’re meant to help.
With the power of RWD, biopharma organizations can close the equity gap and transform good intentions into measurable impact. The tools are here. The industry’s resolve is strong. Now, it’s time to deliver.
About Jeffrey Brown, PhD
With more than 25 years of experience in research and consulting, Jeff is an internationally recognized expert in the use of RWD to support the evidentiary needs of regulatory agencies and medical product sponsors and an expert in the assessment of data quality of RWD resources.
