As trial sponsors attempt to recruit more subjects from diverse racial and ethnic backgrounds, some are finding themselves impeded by a symptom of a long-standing disease in American medicine: mistrust in the healthcare system.
In a white paper released June 25, investigators from commercialization solutions firm Trinity Life Sciences described the efforts trial sponsors are undertaking to diversify clinical trials. Five of the 15 executives they spoke with for their research mentioned mistrust in the healthcare system is a factor that’s keeping their companies from reaching their enrollment goals, according to the paper.
“There's a fundamental lack of trust in clinical research that is higher in nonwhite populations, particularly African American populations. The whole history of the Tuskegee trial related to syphilis has left a fundamental lack of trust, particularly among older African American individuals to participate in clinical research,” one vice president of medical affairs, who was not named, reportedly told Trinity researchers. “So, overcoming that and overcoming other issues related to trust, takes a lot of work and effort.”
Trinity investigators dug into U.S. pharmaceutical and biotech company's financial documents, investor presentations, press releases and other primary sources to conduct their research, focusing on those generated between 2018 and 2023. They used a program called AlphaSense to look for mentions of “clinical trials” and “diversity” within them.
They also conducted 45-minute, one-on-one telephone interviews with company executives who were in charge of implementing diverse recruitment practices into clinical trial design and execution. All participants had held their positions for at least one year.
Trinity found that most companies are investing in diversity initiatives and tend to execute them in similar ways, such as working with multicultural communities, setting diversity goals that are aligned with disease prevalence and coming up with diversity measurement tools. Many also implemented decentralized clinical trials that meet patients in their communities rather than requiring them to come to academic centers.
“It is clear that the pharmaceutical industry as a whole has committed to increasing diversity, laying out plans and targets for their clinical trials and implementing new practices to increase diversity,” the report read. “However, actual reporting on outcomes remains sparse.”
One exception is GSK, Trinity noted. The pharma giant reported at the end of 2022 that 100% of its phase 3 clinical trials include a diversity plan, as FDA guidance recommends, and it tends to be more transparent about metrics and activities than other companies are.
“GSK remains an outlier in terms of company reporting—with most companies providing high level reviews of general activities,” the report read.
If the lack of reporting is a sign that diverse recruitment efforts haven’t yet made the impact pharma companies would like, mistrust could help explain why. Historical exploitation of racial minorities in medical research and ongoing racism in healthcare makes would-be participants—especially those of lower socioeconomic status—reluctant to participate in clinical trials, the report said.
This is compounded by a lack of diverse representation among healthcare professionals and research staff at CROs. Despite the fact that having researchers of the same racial or ethnic background as the target participant demographic improves diverse recruitment, CROs don’t hire trial coordinators on this basis, the report said. While Trinity’s research showed that trial staffers tended to match the race of participants when geography was taken into account, it wasn’t a key factor in CRO selection.