Practical Strategies for Ensuring a Diverse Patient Population in Clinical Trials

Last updated: Nov 10, 2025

Clinical trials are becoming more complex. The number of endpoints, procedures, and sites used per study have all increased. This makes recruiting patients — and particularly diverse patients — more difficult.

Introduction

The clock is ticking on the requirement for pharmaceutical companies to include diversity action plans (DAPs) for pivotal studies in their clinical trials. A few deadlines have slipped since the Food and Drug Omnibus Reform Act (FDORA) was signed into law in April 2022 but the deadline for comments on the FDA’s draft guidance on DAPs passed on Sept. 26, 2024. The guidance is mandated to be final on June 26, 2025, and the act should go into effect 180 days later. Citeline experts regard these reforms as necessary and in the industry’s interests for many reasons.

“Medications can work differently in different populations. If we’re not able to test medications across all races, ethnicities, genders, and ages, then we don’t know how they work in these populations,” says Jessica Washington-Moore, Senior Director of Implementation at Citeline. “If we know that these medications are safe and effective in certain populations, we can provide the right level of care and increase access to underrepresented communities.”