The next time you’re at the drugstore, you might be able to do more than buy aspirin and toothpaste: A nationwide pharmacy chain has started a clinical trials division to identify customers who can help deliver the next generation of lifesaving treatments.
It was part of a trend towards decentralized clinical trials that exploded during the pandemic, when researchers had to figure out how to continue critical testing during lockdowns.
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“COVID-19 is definitely an impetus to re-evaluate how we conduct clinical trials,” said Ramita Tandon, chief clinical trials officer at Walgreens, which has installed dedicated clinical trial centers at 15 dispensary locations across the country.
“While everything is closed, retail pharmacies are still open and can provide vaccines across the US,” Tandon told CNET. “I think the clinical trial industry quickly realized that this was a way to reach more people in general and to reach more diverse populations in particular.”
What is a clinical trial?
Any treatment that seeks approval from the US Food and Drug Administration, whether it is a cholesterol-lowering drug or a pacemaker, must go through a clinical trial process, in which researchers ask volunteers to test its efficacy and safety. Also known as intervention studies, these tests can be sponsored by pharmaceutical companies, federal agencies such as the National Institutes of Health or even doctors, scientists or academics.
Clinical trials are often designed to determine whether new treatments are more effective or have fewer side effects than existing therapies, according to the National Institute on Aging, although they can also be used to uncover new ways to diagnose disease, preventing health problems. or improve the quality of life for people living with chronic conditions.
In January, there were nearly 39,000 active clinical trials in the US, according to the National Library of Medicine.
This is big business — one that will generate nearly $28 billion in revenue by 2022. But historically, finding qualified participants and keeping them enrolled was a major hurdle. Being a test subject can be inconvenient and time-consuming: Participants traveled an average of 67 miles each way last year to reach the test site.
Unsurprisingly, 80% of clinical trials fail to meet their targets and enrollment schedules, costing drug developers millions of dollars in revenue and delaying the development of drugs, devices and other critical treatments.
Hoping to meet that need, Walgreens, Walmart, CVS, and Kroger have all launched clinical trial divisions in the past two years.
Pharmacies say they are focused on making clinical trials more convenient and diverse and improving health outcomes for their customers.
“If you saw a trial at an academic institution 30.40 miles away, you’d say, ‘Forget it. This is too far,'” Tandon told CNET. “But if you can get to a Walgreens that’s maybe five miles away, you’re more likely to participate and complete the pilot.”
But there’s no guarantee of success: One major player has canceled its clinical trial program. And a retailer’s paid partnerships with major pharmaceutical companies can raise questions about patient privacy.
Typically, pharmacies will contact customers who have opted in to receive the communication and who meet the initial testing criteria. If they are interested, participants will come to the nearest branch established with a clinical trial center and given further details and a prescreening evaluation.
Once the trial has started, patients can undergo diagnosis and have their blood drawn at the pharmacy. Depending on the request of the client company, they may be provided with a wearable digital device to monitor them at home.
Amir Kalali, a physician scientist and co-founder of the Decentralized Trials & Research Alliance, said retail pharmacies also have the advantage of existing relationships with customers.
“It can make a difference in building trust,” says Kalali, “when you get someone to understand what’s involved or try to get them to follow through and complete the trial.”
Increasing diversity in clinical trials
Building a dispensary customer base has other benefits: Pfizer, Gilead, and other biopharmaceutical companies are eager to diversify their patient pools. Although less than 60% of the US population is white, white people make up 75% of clinical trial participants, according to data from the FDA.
Blacks, Hispanics, and Asians are all underrepresented in medical studies, although 20% of drugs show some differences in response between ethnic groups.
And even though more than half of cancer patients are women, only 41% of participants in oncology trials are women, according to research published last year in Contemporary Clinical Trials.
Advocates have been calling for better representation for years. Passed in December as part of the 2023 omnibus spending bill, the Diverse and Equitable Participation in Clinical Trials Act (DEPICT) requires researchers to have a strategy in place to introduce more diversity into their recruiting efforts. With thousands of locations, say major pharmacies, they can leverage their convenience and ability to reach underserved groups.
When Walmart launched its Healthcare Research Institute to start trials in October 2022, Walmart stated that its focus would be on “innovative interventions and medicines that can make a difference in underrepresented communities”, including women, older adults, rural residents, and minorities.
There are more than 5,000 Walmart pharmacies in the US and Puerto Rico. According to the company, 4,000 are in settings without access to primary care services.
“This puts Walmart in a unique position to reach traditionally underrepresented people and offer access to healthcare research where they shop for groceries,” John Wigneswaran, Walmart’s chief medical officer, told CNET by email.
“We are already in our local community,” added Wigneswaran. “We have relationships with thousands of customers and can use our approach as a trusted voice in the community.”
Wigneswaran says Walmart is initially focused “on chronic conditions, such as diabetes, cardiovascular disease, COVID-19 and asthma,” but additional diseases, including HIV, dementia and obesity, are also on the radar for future clinical trials.
Taking clinical research out of the lab and to the nearest drugstore is a big step forward, according to Moe Alsumidaie, founder of CliniBiz, which is working to make research more efficient and affordable. Staff must be trained and the pharmacy itself needs to be equipped with private exam rooms and special research equipment.
“It’s not like sitting in a chair and waiting for your vaccine to be administered,” says Alsumidaie. “Clinical trials are much more involved.”
Of course, pharmacies are well compensated for their efforts. Tandon describes Walgreens’ clinical trial program as a “fully revenue-generating business model.”
“When manufacturers reach out to Walgreens, there’s a menu of services they can choose from,” says Tandon. “And there is a fee structure involved.”
To build a list of candidates, pharmacies mine the data they have on their customers’ age, gender, and medication history. They don’t record race or ethnicity, but knowing a customer’s address can help narrow down their demographic information.
Walmart’s Wigneswaran said securing protected health information and maintaining trust with patients “is a top priority”.
And according to the FDA, retail pharmacies are subject to the same regulatory requirements as other research facilities.
“The FDA may conduct inspections to ensure that trials conducted in retail pharmacies are conducted in accordance with regulatory requirements, including those relating to the protection of the rights, safety, and well-being of trial participants,” the agency told CNET by email.
To support the expansion, the US Food and Drug Administration released additional draft guidelines in May.
Kalali says concerns about privacy are really part of the larger conversation.
Customer information “is already being sold by pharmacies to a lot of data aggregators,” he told CNET. “People are monetizing patient data these days. I’m not sure decentralized trials in pharmacies are any different in how we handle patient information. The real question is, ‘Should patients have their own health data?'”
The future of clinical trials is decentralized
Kroger, which operates nearly 1,200 pharmacies in the US, announced its first clinical trial partnership in January, a partnership with Persephone Biosciences to find candidate studies on gut health and its impact on colorectal cancer.
According to the American Cancer Society, African Americans are 20% more likely to develop colorectal cancer than the general population, and about 40% more likely to die from it.
The supermarket chain declined to comment on its program, but in a release, Kroger Health’s chief commercial officer, Jim Kirby, said the cancer trial would be the first of many “that will leverage us as an alternative to the traditional clinical trial and research organization model.”
Walgreens, which launched its clinical trials business in June 2022, has about a dozen studies in various stages of development. One that has made headlines involves the PRX012 antibody, which the FDA has been fast tracking as a potential treatment for Alzheimer’s disease.
Overall, more than 2 million Walgreens customers have been contacted to participate in clinical trials, says Tandon, and the chain has seen positive trends in recruiting diverse participants: As of June 2023, African Americans represented 17% of patients who had been enrolled. clinical trials, while Latinos accounted for 15%.
CVS Health was the first to launch a clinical trial program, in May 2021. But the country’s largest pharmacy chain has announced it will be going out of business in just two years. It expects to completely phase out its services by the end of 2024.
Asked why, CVS simply said that, “We are continuously evaluating our asset portfolio to ensure it is aligned with our long-term strategic priorities.”
The clinical trial business isn’t for everyone, says Alsumidaie. It is a highly regulated industry that involves a lot of institutional oversight, careful storage of sensitive information and the potential for adverse reactions among patients.
But the CVS decision should not be taken as a sign that it is not the right path, he added.
“That could be due to a variety of factors — strategic realignment, competition, operational hurdles, financial implications and different industry trends,” said Alsumidaie.
Kalali is also optimistic about the future involvement of pharmaceutical chains in decentralized clinical trials. The goal, he says, is not to replace traditional test venues, but to provide patients with options.
“What we want to look at is a situation where some things you have to go to a physical location, and other things you can assess at home,” he said. “That’s what we’re really aiming for: for patients to fit the trial into their lives, as opposed to them having to adjust to the protocol.”
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