Clinical trials are the way pharmaceutical companies and other health care researchers determine whether a new drug or treatment is safe — but the participants in those trials are overwhelmingly White.
According to Walgreens, which announced last June that it was entering the clinical trials business, only about 5% of people in the United States participate in clinical trials and almost three-quarters of those participants are White.
There are multiple reasons for that lack of diversity — but it can have life-and-death consequences for people of color.
Kendal Whitlock is head of digital optimization for Real World Evidence Clinical Trials for Walgreens. The nationwide pharmacy chain aims to partner with pharmaceutical companies and other research institutions and leverage its vast network of stores to transform the way clinical trials are conducted.
At the core of Walgreens’ mission, said Whitlock, is creating greater access and inclusion.
“By virtue of having 78% of the country within five miles of a Walgreens location means that patients have access in a manner that’s convenient for them because they’re already in the Walgreens stores for other reasons,” said Whitlock.
“Where clinical trials are concerned, there are ‘identified barriers to participation’ that have meant people of color are underrepresented,” said Whitlock. “One of the barriers is mistrust or distrust. And there are longstanding historic reasons for the mistrust and the distrust. People often cite the experience that Mrs. Henrietta Lacks had. People often cite the Tuskegee experiment. And those are just two examples over a 300-year history of medical atrocities that was elucidated by Harriet Washington in the book ‘Medical Apartheid.’ And this was not limited to the United States, but this was globally and across all communities.”
While overt racism in clinical trials of the past may still be a factor in discouraging participation, other more mundane factors may also be at play.
“From the patient perspective, sometimes it’s the inconvenience of having to travel up to two hours to a clinical trial site,” said Whitlock. “It you are an employee of a company and asking your boss if you can take time off from work to travel to and from clinical trial sites that are very limited, your boss may not see that favorably.”
Dr. Jecca Steinberg, a resident in the obstetrics and gynecology department at Northwestern University’s Feinberg School of Medicine, has conducted research into the lack of diversity in clinical trials.
Steinberg said that while there are historical factors that discourage communities of color from participating in clinical trials, those may be becoming less of a factor.
“Recent data has demonstrated that all individuals regardless of their race and ethnicity are equally willing to participate in clinical trials and research,” said Steinberg. “The hesitancy actually lies with researchers who are afraid to approach people who are not of their race due to fear of stigma or bias or stereotyping their patients, assuming they might not be interested.”
The consequences of the failure to have clinical trials that reflect the diversity of the population can lead to poor health outcomes.
Steinberg noted that the clinical trial that produced the tools widely considered the “gold standard” for screening for endometrial uterine cancer only had White participants and subsequently turned out to be less accurate at detecting cancer in Black women.
“The tools have been reevaluated in a more diverse population, and they are not as effective at detecting cancer in Black communities,” said Steinberg. “We know that Black women are three times more likely to die of endometrial cancer. And part of the reason for that is because they are diagnosed at much later stages.”
Dana Dornsife in 2006 founded the Lazarex Cancer Foundation, a California-based nationwide nonprofit, after the experience of searching for clinical trials for her brother-in-law Mike, who had pancreatic cancer.
“I was just really struck by how difficult that whole undertaking was,” said Dornsife. “And then when I was able to get Mike enrolled in a trial, we started reaching into our pocket over and over and over again to pay for the expenses that aren’t covered in a clinical trial. And I just realized what a barrier both of these things are for patients in relation to considering trial participation knowing about a trial because if you don’t know, you won’t go.”
Lazarex aims to improve cancer patients’ outcomes by helping people find and then access clinical trials by covering out-of-pocket travel costs for a patient and caregiver. And according to Dornsife, Lazarex has made great strides in encouraging people of color to participate in clinical trials.
“Because poverty disproportionately impacts our communities of color, we see that reflected in the overall participation numbers in clinical trials,” said Dornsife. “By removing the barriers that exist for our communities of color to participate and doing it in a culturally appropriate and place-based way, we can absolutely reduce or remove those barriers for these communities and increase the level of participation and we’ve actually proven that.”