On 19 November 2024, the Biotechnology Innovation Organization (BIO) hosted its annual Clinical Trial Diversity Summit at Howard University in Washington, D.C., spotlighting one of the most urgent challenges in clinical research: the lack of diversity in trial populations. The event brought together researchers, regulators, industry leaders, and community advocates to explore actionable strategies for inclusive trial design.

The summit’s centerpiece was the announcement of the National Research Center for Health Disparities (NRCHD), a 200,000-square-foot facility dedicated to advancing research and policy focused on underserved populations. Howard University President Dr. Ben Vinson III emphasized the center’s mission to integrate community voices with cutting-edge science, targeting diseases that disproportionately affect minority groups—including diabetes, sickle cell disease, cancer, and cardiovascular conditions.

Martin Mendoza, Ph.D., Chief Health Equity Officer at the Centers for Medicare & Medicaid Services (CMS), delivered the keynote address, highlighting stark disparities in trial representation. While minority groups make up nearly 38% of the U.S. population, they account for less than 10% of clinical trial participants. Mendoza stressed that this gap is not only a moral issue but a scientific one: “When minority populations are excluded, trial results may not reflect the full spectrum of affected individuals, leading to treatments that are less effective—or even harmful—for those left out.”

The summit also reviewed recent FDA diversity action plans, which now require Phase III trials to include populations representative of those most affected by the target condition. These mandates are expected to influence trial protocols, site selection, and recruitment strategies across therapeutic areas.

For clinical researchers, the NRCHD and evolving regulatory frameworks signal a shift toward more inclusive, community-engaged trial models. Sponsors and CROs are being urged to build trust with marginalized populations, invest in culturally competent outreach, and design trials that reflect real-world demographics.

As Mendoza concluded, “Equity in clinical research isn’t just about fairness—it’s about scientific rigor and public health impact.”