Why Latino Underrepresentation In Clinical Trials Is Becoming a Commercial Liability

63 million Americans. $3.4 trillion in GDP. 6-11% trial representation.

These numbers tell a story biotech and pharma leaders can no longer afford to ignore.

This article is not about fairness or moral obligation; it’s about economics, risk, and competitiveness. While health equity is a critical goal that I have addressed in depth in a separate edition of this newsletter, here the focus is on how underrepresentation impairs forecasting, distorts the science underpinning drug launches, and leaves millions of dollars in potential growth and patient value unrealized.

A Subtle but Growing Strategic Blind Spot

Latinos now make up nearly one in five Americans, reshaping the nation’s workforce, economy, and patient population. They carry a disproportionate burden of high-impact diseases like diabetes, obesity, liver disease, and heart disease. Yet in the data that guides drug development, they typically account for less than 10% of clinical trial participants, and as little as 3–6% in some key therapeutic areas.

For decades, that gap didn’t seem to matter much. Clinical evidence held up, sales grew, and payers rarely asked whether the data matched the diversity of the market. But that equation is changing. Over time, as the size of the Latino population grows faster than any other ethnicity in the U.S., the lack of Latino representation in clinical trials becomes more than a scientific uncertainty. It becomes a business risk.

The Latino Economy and the Future of Market Growth

The U.S. Hispanic population already generates $3.4 trillion in GDP, an economy that would rank fifth in the world, just behind Germany.

When Hispanic patients are undercounted, disease prevalence is underestimated. When prevalence is underestimated, market forecasts shrink. When forecasts shrink, access strategies and payer models misprice risk. That mispricing then affects launch uptake, payer negotiations, and ultimately revenue performance.

This is not about inclusion. It is about financial accuracy.

Some still argue that low Hispanic insurance coverage weakens their commercial relevance, especially amid Medicaid rollbacks and ACA uncertainty. That argument is outdated.

Census and CMS projections show Hispanics will account for over 30% of the U.S. working-age population by 2040, which means they’ll dominate the employer-based insurance segment, the primary revenue base for most drug launches.

Medicaid disenrollments don’t erase demand, they shift it to safety-net providers, community clinics, and commercial plans are now under pressure to diversify enrollment.

Ignoring this population caps growth.

Data-Driven, Yet Demographically Blind

Drugmakers are already navigating complex pricing debates and increasing payer scrutiny. But one of the least discussed vulnerabilities in launch planning is demographic misalignment: when the patients included in research don’t reflect those driving real-world disease burden.

Recent analyses suggest that Hispanic participation in U.S. clinical research still trails both population and disease burden. Across more than a thousand GSK-sponsored trials conducted between 2002 and 2019, Hispanic enrollment averaged 14 percent: below their share of the U.S. population and well under their prevalence in conditions like COPD, HIV, and asthma according to the census.

Most companies use vast insurance claims and electronic-health-record databases like IQVIA, Optum, and Marketscan to model prevalence and patient flows. But those datasets carry the same blind spot in a more technical form: they systematically undercount Hispanic/Latino patients, particularly those in Medicaid or safety-net care. Even when ethnicity is recorded, misclassification rates can exceed 30 to 40 percent, Hispanic ethnicity missing in up to half of commercial claims, and uninsured visits or 340B prescriptions rarely appear in claims data.

It’s not prejudice that drives the gap. It’s outdated data pipelines and incomplete population models. And this is not just on the industry. Many companies have proactively increased efforts to diversify clinical trials. However, many Hispanic and Black patients hesitate to join research for reasons that are both understandable and preventable: language gaps, logistical hurdles, and generations of earned mistrust.

When Representation Meets Disease Burden

In a diabetes clinic in Houston or LA, nearly every patient many doctors see is Latino. Yet in the data that shapes drug development, that reality all but disappears. Clinical trials and real-world evidence systems were built for an older America; one that no longer matches who’s actually in the waiting room.

Among Hispanic adults, Type 2 diabetes rates range from 11 to 18 percent: nearly twice as high as non-Hispanic Whites. Hispanic adults also show higher rates of obesity (44% for both men and women versus 37%), metabolic syndrome, and earlier onset hypertension, with less diagnosis, treatment, and risk control overall. Nearly half experience nonalcoholic fatty liver disease (NAFLD) compared to one third of non-Latino Whites. These patterns result in higher mortality from chronic liver disease and persistent care gaps for cardiometabolic and respiratory illness. These are not rare diseases. They are the backbone of global drug pipelines.

For drugmakers, high disease burden in a growing population is not just an epidemiologic reality. It is a commercial signal. Underrepresenting these patients in evidence development means underestimating future demand.

And the gap doesn’t end with clinical trials. Even when therapies like GLP-1 RAs and SGLT2 inhibitors prove effective, studies show they are prescribed less often to Hispanic and Black patients, even in health systems like the VA, where cost barriers are minimal. These disparities persist after adjusting for comorbidities, access to specialty care, and social determinants of health, meaning the issue isn’t just affordability or eligibility. It reflects deeper structural patterns in how new therapies diffuse into practice.

For companies, this creates a second form of blind spot: not only are the clinical datasets incomplete, but the real-world utilization curves are skewed. I’ll explore those access and prescription inequities in a separate edition, but the economic signal is already clear: unmet need does not automatically translate to real-world uptake unless the evidence, tools, and engagement models are built with these populations in mind.

Fixing the Representation Equation

Closing the Latino representation gap requires rebuilding pieces of the evidence infrastructure: not only trial enrollment but also how ethnicity and social determinants are captured across claims, electronic health records, and community care.

Key actions for biotech and pharma leaders include:

• Embedding representation metrics into early trial design and site selection.

• Partnering with Hispanic-serving health systems and research networks.

• Auditing data providers for ethnic misclassification and undercounting bias.

• Aligning field medical and access teams with Hispanic provider networks.

• Treating representation ROI as a measurable launch parameter, not a qualitative goal.

While industry efforts are gaining momentum, regulatory clarity has taken a step back. In January 2025, the FDA quietly removed draft guidance that would have required Diversity Action Plans in clinical trials, following a federal order limiting diversity programs. The change leaves sponsors uncertain about how the agency will enforce upcoming requirements under the Food and Drug Omnibus Reform Act. 

For companies betting on inclusive pipelines, the signal is clear: representation can’t wait for regulation. The market rewards those who lead on data accuracy, not those who follow policy shifts.

Regulatory unpredictability creates operational uncertainty: the most expensive form of uncertainty in drug development.

Community mistrust and logistical barriers among Hispanic patients are real but addressable with sustained outreach. When representation becomes a core metric of trial and market readiness, it reduces scientific uncertainty while expanding commercial opportunity.

The Boardroom Takeaway

For biotech and pharma leaders and boards, this isn’t a DEI conversation. It’s a risk management one.

At your next strategic review, ask:

• Do our trials reflect the patients we’ll actually treat?

• Do we measure return on representation with the rigor we apply to ROI?

• Are our forecasts built on disease prevalence or outdated population averages?

• Do our medical affairs, field medical, and access teams have the tools to engage Hispanic providers and communities early?

Diversity isn’t a moral accessory to innovation. It’s market intelligence. The companies that accurately reflect the real patient population in their R&D and access models, will define the next generation of biotech leadership; and those who understand the Latino health economy in the U.S. won’t just lead in inclusion, they’ll lead in performance.

The companies that fix the representation gap will see it reflected not only in better science, but in stronger forecasts, smoother payer engagement, and more durable launch curves.

Additional References:

• Kelsey MD, Patrick-Lake B, Abdulai R, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022;116:106740. doi:10.1016/j.cct.2022.106740

• Turner, Brandon E. et al. Race/ethnicity reporting and representation in US clinical trials: A cohort study. The Lancet Regional Health – Americas, Volume 11, 100252

• Oberlander, J. Progress Lost — The Unraveling of Medicaid and the Affordable Care Act. N Engl J Med 2025;393:628-629

• Reid MM, Davis SP, Henry ON, et al. Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials. Clinical Trials. 2023;20(2):133-144.

• Eberly LA, Yang L, Essien UR, et al. Racial, Ethnic, and Socioeconomic Inequities in Glucagon-Like Peptide-1 Receptor Agonist Use Among Patients With Diabetes in the US. JAMA Health Forum. 2021;2(12):e214182. doi:10.1001/jamahealthforum.2021.4182

• Nead K.T., Hinkston C.L., Wehner M.R., “Cautions When Using Race and Ethnicity in Administrative Claims Data Sets”, JAMA Health Forum, 2022.

• Jarrín OF, et al., Validity of Race and Ethnicity Codes in Medicare Administrative Data, Medical Care, 2020. Found under-counting of Hispanic/Latino individuals in Medicare admin data.