To Increase Diversity in Clinical Trials, First Increase Staff Diversity
White patients are highly overrepresented in clinical trials—the studies that assess the safety and efficacy of vaccines, drugs, and other medical treatments. This means researchers are missing vital information about how members of other racial and ethnic groups may respond to treatments.
To correct that, the FDA has issued guidance on ways to recruit more diverse patients for clinical trials, such as improving outreach efforts and making it easier to participate. But according to recent research from the Tufts Center for the Study of Drug Development at Tufts University School of Medicine, a key factor in enrolling diverse patients is having diverse staff working at the investigative site.
“We tend to look for external areas to implement change and reform; this study really gives us pause and gets us to look within,” says Kenneth Getz, director of the center and a research professor at the School of Medicine. “Communication and education of the patient community alone is not necessarily enough. We have to look at our ability to attract more diverse personnel to reflect the diversity of the communities we’re trying to reach.”
Getz and his colleagues conducted an online survey of investigative sites running clinical trials around the world. They received responses from site directors, investigators, and study coordinators from 3,187 different sites, representing almost 40% of sites conducting industry-funded clinical trials worldwide.
Across the board, the researchers found that sites with higher racial and ethnic diversity among staff members saw that reflected in the patients they enrolled. Sites with higher levels of staff diversity were also more likely to report that they viewed diversity as a critical aspect of success and incorporate mission statements, operating procedures, and training programs to reinforce diversity awareness and importance.
“For a long time, professionals within the drug development world have suspected that site personnel diversity and patient enrollment diversity are related, but this belief has not been demonstrated quantitatively,” Getz says. “The results of this robust study unequivocally show a very strong correlation.”
The researchers also found that private sector sites, including dedicated clinical research organizations and private practices, frequently had more diverse staff than academic medical centers and large hospitals. In the U.S., nearly half of the staff at private sector sites were part of a minority population. At academic centers and hospitals, only one third of personnel were part of a minority.
This was reflected in the patients enrolled in clinical trials at these locations as well. Worldwide, private sector sites reported that slightly more than 40% of enrolled patients were white; in academic medical centers and hospitals, nearly 75% were white.
Typically, a company interested in recruiting a diverse array of patients might seek out investigative sites located in areas with higher concentrations of racial and ethnic minorities, Getz says. But this research suggests that they should also pay close attention to the diversity of the staff working at those sites.
“It’s critical that the site personnel reflect the diversity of the patient community that they're trying to attract and retain in their studies,” Getz says. “Moving forward, in addition to community education and outreach, the selection of investigative sites clearly has an important part to play in improving patient enrollment diversity.”