The New Mandate: How Diversity In Clinical Trials Is Evolving From Ideal To Imperative

By Meredith Landry, Managing Editor, Custom Content, Norstella

A growing consensus among patients, regulators, and industry leaders holds that diverse representation in clinical trials is essential for ethical integrity, scientific validity, and patient safety. The U.S. Food and Drug Administration (FDA) has amplified this shift by recommending Diversity Action Plans (DAPs) that require sponsors to define strategies for enrolling underrepresented populations. While recent political pushback has challenged the policy’s visibility, experts stress that patient-centered intentions must remain unchanged.

Historically, trials have skewed heavily toward white male participants, leaving critical knowledge gaps and, in some cases, producing harmful or ineffective outcomes for other groups. Initiatives now focus on inclusive site selection, flexible protocols to reduce patient burden, and leveraging real-world data on social determinants of health. This broader view of inclusivity extends beyond race and ethnicity to include older adults, non-English speakers, LGBTQIA+ individuals, and people with disabilities. Pharma leaders are adopting practical solutions — from ride-share partnerships to mobile health units — to break participation barriers. As the FDA’s role evolves, reframing DAPs as “Inclusive Research Action Plans” may help maintain momentum in a polarized climate. The goal remains clear: build trials that reflect the full spectrum of patients to deliver safer, more effective treatments and strengthen public trust.