Institutional barriers remain a key driver of health inequities based on race, ethnicity, age, and gender, particularly in the United States. The U.S. Food and Drug Administration (FDA) has taken steps to address these disparities in clinical trial study enrollment over the past two decades, including recent draft guidance issued in June 2024, which mandates diversity action plans for all Phase II and III registrational studies. These regulatory efforts are a helpful step, but much remains to be done in this space.
“Everyone should have the same opportunity to learn about and participate in clinical trials regardless of race, ethnicity, age, or gender,” says Rochelle Williams-Belizaire, a clinical research professional and health equity strategist. “The FDA guidance will help by holding us all responsible and accountable by requiring details of diversity, equity, and inclusion [DEI] goals, metrics, outcomes, and efforts to overcome challenges. The guidance elevates diverse patient enrollment from a discretionary initiative, as in a ‘nice to have,’ to a business imperative in clinical research. It establishes accountability, ensuring that we develop premier therapies designed to benefit all populations, not just a select few.”
Inequities in access to oncology trials are especially concerning, given the rapid advancements in precision oncology, states Williams-Belizaire. “These studies focus on developing targeted therapies based on a patient’s unique genetic and molecular tumor profile,” she notes. “Precision oncology has revolutionized cancer treatment by enabling more effective, personalized interventions; however, this approach also relies on access to cutting-edge clinical trials.”
Patients with aggressive cancers have limited time to navigate multiple lines of treatment. Williams-Belizaire emphasizes, “Clinical trials should not be viewed as a last resort but as a first-line option—providing access to innovative therapies before standard treatments fail. However systemic barriers, including lack of awareness, financial constraints, and limited access to trial sites, disproportionately impact underrepresented populations. Ensuring equitable access to precision oncology trials is not just an ethical imperative but a scientific one—diverse participation is necessary to develop treatments that are effective across all populations.”
“We must be true allies in amplifying patient voices, engaging with communities to understand their concerns and decision-making processes,” notes Williams-Belizaire. “While it is essential to consider the perspectives of regulatory bodies, institutions, and trial stakeholders, it is even more critical to prioritize the needs and solutions identified by cancer warriors, survivors, caregivers, community leaders, and patient advocates—integrating these insights into business strategies and actionable solutions to drive health equity.”
Improving diversity in clinical trials requires proactive, community-driven approaches, according to Williams-Belizaire. “Public health methodologies, such as community-based participatory research [CBPR], can help bridge the gap by prioritizing direct engagement with communities,” she notes. “This means going beyond formal advisory boards to build relationships at the grassroots level, ensuring that community perspectives shape study planning.”
Addressing Health Inequities in Clinical Research
Join Rochelle at ACRP 2025 [April 24-27; New Orleans, La.] as she explores the role of social determinants of health and provide a foundational framework for integrating community-based participatory research into current research projects. View complete schedule.
CBPR can be integrated into key trial processes, including site selection, protocol development (such as refining inclusion/exclusion criteria), and training initiatives that support racial concordance and cultural competency. Incorporating these approaches early in the trial design phase can help mitigate barriers before they arise.
“As the oncology landscape shifts toward making clinical trials a first-line treatment option, a collaborative approach is crucial,” concludes Williams-Belizaire. “We need to include perspectives from caregivers and social networks, local clinics, and health systems alongside traditional stakeholders. The continued challenges in enrolling diverse representation of target populations in clinical trials indicate that systemic and conscious decisions are at play. We are overdue to hold ourselves accountable, move beyond one-time initiatives, and foster long-term partnerships that drive meaningful change. We must be willing to ‘fail quickly together,’ learn from setbacks, and rapidly iterate on new solutions that prioritize equity.”
Author: Jill Dawson
