Add “Taking medications while Black” to the list of inequities Black patients—and many people of color—experience in America.
The historic disenfranchisement of Black people has affected the way drugs are tested. Studies indicate that a lack of participation from those groups has led to adverse side effects in various racial and ethnic groups (and women) because white men are so often the test subjects. The lack of diversity in clinical trials has been so stark that the US mandated pharmaceutical companies to increase diversity in their clinical trials under the 2023 omnibus spending bill enacted in December 2022.
Ramita Tandon, chief clinical trials officer at Walgreens, told attendees at healthcare conference Aspen Ideas: Health last month that “one out of four have some kind of adverse effect in our Black/Brown populations.” That statistic, she said, influenced Walgreens’s decision to enter the clinical trials business in June 2022.
“As we’re trying to build the right highway into our communities to bring trials close to where they are, we get some basic questions that come to our pharmacy care teams [like] ‘What’s a clinical trial?’” Tandon said. “We’re unlocking our locations to become these healthcare destinations and to become these clinical trial hubs.”
What’s in a trial?
Clinical trials are how pharmaceutical companies test whether the drugs they’re developing work. Trials for drugs are done in three phases before the FDA decides whether to approve the drug, and each phase can take years to complete. During each phase, experimental drugs are given to volunteers to test the drug’s safety, dosage, efficacy, and side effects.
Ideally, trial participants are representative of the population that would be taking that drug in the real world if it were to get FDA approval. But not many people in the US participate in clinical trials (just 5% of the total population), and of those who do, three-quarters are white, Tandon told Healthcare Brew in an interview.
Walgreens has access to customer pharmacy information and clinical records, which includes race and ethnicity data. With the clinical trials program, the company uses this data to identify eligible trial participants, Tandon said, making sure they’re reaching out specifically to people of color. Once Walgreens identifies potential participants, employees can initiate contact by email, text, or phone to gauge interest in participating in a trial.
Walgreens has signed eight clinical trial contracts since launching the business last summer. Two trials are with Prothena Biosciences and Freenome, though Walgreens hasn’t publicly named the other pharmaceutical companies.
For each clinical trial Walgreens works on, the partnering pharma company will set specific objectives for the number of participants from groups that “typically have been neglected historically,” Tandon said. For its recently announced Alzheimer’s trial with Prothena, for example, the pharma company set attracting Black and Hispanic populations as a key requirement, she said.
Blocking the path
Internally, Walgreens uses three key performance indicators to determine success in its clinical trials business, Tandon said in Aspen. The retail pharmacy giant turned healthcare organization looks to tackle access, make trials easier for patients to comprehend, and train pharmacists and clinicians to talk about clinical trials with patients as part of their care.
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But there are some big hurdles.
“I can tell you, the trials we’re running today—it’s hard. We have patients dropping out because it’s too complex. The consent is too complex. The protocols are too complex,” Tandon said in Aspen. “At the end of the day, whether it’s our Hispanic populations, our Black populations, they’re saying, ‘You know what, forget it.’”
One major challenge for participants is a lack of access to technology, Tandon said.
Technology is used in many ways to make clinical trials more convenient, like using telehealth to connect with participants for prescreenings or to check in during the trial. But if people don’t have access to the necessary technology for a telehealth visit, these options for increasing convenience go out the window.
“There are communities that have major digital divides, and broadband access is not consistent across my Black and Brown populations I serve,” Tandon said in Aspen. “I’m partnering with organizations like Verizon to leverage federal programs so that those patients—we can unlock those system-level barriers—and they can participate in clinical trials. That’s the reality that we face.”
Verizon did not return Healthcare Brew’s request for comment.
Another challenge is access to transportation for participants to get to places where clinical trials are conducted, Tandon said in an interview. Traditionally, trials are conducted at hospitals, universities, doctors’ offices, and community clinics. But some people, especially those in rural areas, don’t live close to any of those facilities. For example, 18% of people in the US live more than 10 miles from the nearest hospital, according to Pew Research Center.
About 78% of the US population lives within five miles of a Walgreens, so the company has designated 15 of its stores as clinical trial hubs, Tandon said in Aspen. The hubs can be used in part to educate patients on what being in a clinical trial entails, but they can also be used for low acuity services that take place in clinical trials, like screenings and blood draws.
“We want to continue to expand our physical footprint in where we have clinical trials centers, to afford more accessibility and convenience for our patients to participate,” Tandon said in an interview.