07 Jul Patient diversity in clinical trials: How to meet the need

By James J. Gillespie and Joseph P. Gaspero, Center for Healthcare Innovation via Clinical Leader

We need a new paradigm for increasing diversity in clinical trials. Identifying, recruiting, and retaining study participants are essential to trial success. In the case of prospective participants who are racially and ethnically diverse, the challenges are particularly profound.

The study participants in clinical trials are often homogenous. In 2020, the FDA analyzed global clinical trial participation and found significant differences between the enrolled participants and the global population. Of the nearly 300,000 global trial participants, 76% were white, 11% were Asian, and only 7% were Black. In contrast, the 7.8 billion global population is approximately allocated as 60% Asian, 16% African, 10% European, and 8% Latin American. Historically, in the U.S., drugs have been tested primarily on white Americans, particularly young and middle-aged men of European descent. Although 39% of the U.S. population is composed of people of color, they account for less than 16% of those in clinical trials. Black patients consistently account for only 5% of clinical trial participants in the United States. Even more striking, although Hispanic Americans are 16% of the overall population, they compose only 1% of those in trials.

The persistent overrepresentation of white participants in clinical trials is particularly striking considering the heavy burden of chronic disease in minority racial and ethnic populations. The disproportionate negative impact of the COVID-19 pandemic upon Black and Latinx communities in the United States brought the topic of health disparities into sharp focus. We know that COVID-19 has disproportionally impacted racial and ethnic minority populations, particularly African American, Hispanic/Latino-American, and American Indian/Alaska Native patients, with a hospitalization rate three times higher than whites. COVID-19 particularly laid bare certain health disparities given that racial and ethnic minority groups experienced higher rates of hospital admissions, critical-care admissions, and mortality. Read more …