Why We Must Diversify Clinical Trials: The Urgent Case for Inclusive Medical Research
The decision to diversify clinical trials is no longer optional — it is one of the most pressing scientific and public health imperatives in modern medicine. Minorities currently account for fewer than 10 percent of patients enrolled in clinical trials in the United States, despite representing nearly 40 percent of the total population. This gap undermines the quality of medical evidence, limits access to emerging therapies for underserved communities, and produces treatments that may work well for some patients but not for others.
Understanding why it is essential to diversify clinical trials requires looking at the problem from multiple angles: regulatory, scientific, ethical, and economic.
What the FDA Is Doing to Diversify Clinical Trials
Federal regulators have recognized the urgency of this issue for over a decade. In 2012, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act, giving the FDA a direct mandate to evaluate underrepresentation and take action. Two years later, the FDA released an Action Plan calling on clinical researchers to include data from the full demographic spectrum in their studies.
The regulatory direction is clear: efforts to diversify clinical trials are moving from recommendation to requirement. Data representing diverse populations will increasingly be necessary for studies to receive FDA acceptance. This shift reflects a growing recognition that a trial’s scientific merit is inseparable from the representativeness of the population it studies.
Health Disparities Make It a Scientific Necessity to Diversify Clinical Trials
Health disparities — differences in health outcomes between populations based on race, ethnicity, sex, age, disability, socioeconomic status, and geographic location — are not only social phenomena. They have biological and pharmacological dimensions that make the push to diversify clinical trials a matter of scientific accuracy.
Because of genetic differences, some people’s bodies process drugs in significantly different ways. Racial and ethnic categories can serve as meaningful proxies for those differences. One of the most well documented examples involves African Americans and Puerto Ricans, who do not respond as well to some of the most common asthma controller medications — even though these two groups bear the highest burden of asthma in the United States. When the populations most affected by a disease are not represented in the trials that test its treatments, the resulting therapies may be systematically less effective for them.
This is why researchers and regulators alike agree that to diversify clinical trials is to produce better science — science that works for everyone, not just the populations most conveniently enrolled.
Who Has Been Left Out and Why It Matters
Historically, the elderly, women in certain therapeutic areas, and racial and ethnic minorities have been consistently underrepresented in clinical research. The NIH has documented this pattern in recent years, with particular attention to the low inclusion of Black and African American participants and other minority groups across therapeutic areas.
The numbers are difficult to ignore. African Americans represent 12 percent of the U.S. population but only 5 percent of clinical trial participants. Hispanics make up 16 percent of the population but account for just 1 percent of trial participants. Only 2 percent of cancer studies and fewer than 5 percent of pulmonary studies have enrolled enough minority participants to generate statistically meaningful data about how those populations respond to treatment.
These figures come from the 2011 report produced at the FDA sponsored conference “Dialogues on Diversifying Clinical Trials” and remain relevant today. As the United States grows more diverse, the failure to diversify clinical trials becomes an increasingly serious gap between the populations studied in research and the populations that receive the resulting treatments in practice.
Better Evidence Requires a More Diverse Research Population
One of the strongest scientific arguments to diversify clinical trials is the impact on evidence quality. When a medical product is evaluated across the full demographic spectrum before it reaches the market, regulators and clinicians can be confident that the trial results will translate into real world practice for patients of different ages, ethnicities, sexes, and genetic backgrounds.
Moving from a clinical trial result to clinical application is always complex. But that translation is far more reliable when the population studied reflects the population that will ultimately be treated. Without representative enrollment, the evidence produced may not apply equally to everyone who receives the drug or therapy after approval — a gap with real consequences for patient safety and treatment effectiveness.
This is why evaluating minority recruitment is increasingly being considered a criterion for determining the scientific merit of research proposals. To diversify clinical trials is to strengthen the foundation on which all subsequent medical decisions are built.
Access, Equity, and the $300 Billion Cost of Inaction
Beyond the scientific rationale, there is a compelling equity argument for the effort to diversify clinical trials. Participation in research should be available to a wide range of people — both for the access it provides to emerging therapies and for the opportunity to contribute to treatments that benefit everyone. For many patients in underserved communities, clinical trial participation represents access to care that would otherwise be out of reach.
The economic stakes are significant as well. Health disparities are estimated to cost the United States approximately $300 billion annually. Closing the representation gap in clinical trials is one of the most direct and evidence based strategies available for reducing those disparities over time and producing a body of medical knowledge that truly reflects the full diversity of the American population.
For more on health disparities and their impact on research, the CDC Health Disparities and Inequalities Report provides comprehensive data across demographic groups.
How FOMAT Medical Works to Diversify Clinical Trials
At FOMAT Medical, the commitment to diversify clinical trials is built into every stage of our research operations — from site selection and team composition to recruitment pathways and community outreach. Our sites, teams, and enrollment strategies are specifically designed to reach people who are usually underrepresented in clinical research, producing data that better reflects everyday patients and their realities.
By working within local communities, reducing participation barriers, and building trust through clear communication, we help ensure more inclusive enrollment across our national network of clinical trial sites. We actively work to increase Black and African American participation in clinical trials, and our approach to diversity guides how we plan recruitment so studies move closer to accurate representation at every phase.
If you want to learn more about how FOMAT approaches diversity in clinical research and how you or your community can get involved, visit our diversity page.