The next time you're in the drugstore, you might be able to do more than stock up on aspirin and toothpaste: National pharmacy chains have started clinical trial divisions to identify customers who could help usher in the next generation of lifesaving treatments.
It's part of a trend in 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 was definitely the impetus for reevaluating how we did clinical trials," said Ramita Tandon, chief clinical trials officer at Walgreens, which has installed special clinical trial centers at 15 pharmacy locations nationwide.
"When everything was shut down, retail pharmacies were still open and were able to administer vaccines across the US," Tandon told CNET. "I think the clinical trial industry quickly realized 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 seeking approval by the US Food and Drug Administration, whether it's a cholesterol-lowering drug or a pacemaker, has to go through the clinical trial process, where researchers enlist volunteers to test its efficacy and safety. Also known as interventional studies, these tests can be sponsored by pharmaceutical companies, federal agencies like the National Institutes of Health or even individual doctors, scientists or academics.
Clinical trials are often designed to determine if a new treatment is more effective or has fewer side effects than an existing therapy, according to the National Institute on Aging, though they may also be used to uncover new ways to diagnose a disease, prevent 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.
It's a big business -- one that generated nearly $28 billion in 2022. But historically, finding qualified participants and keeping them enrolled has been a major obstacle. Being a test subject can be inconvenient and time-consuming: Participants traveled an average of 67 miles each way last year to reach a testing site.
Unsurprisingly, 80% of clinical trials fail to meet their enrollment target and timelines, costing drug developers millions of dollars in lost revenue and delaying the development of critical drugs, devices and other treatments.
Hoping to address that need, Walgreens, Walmart, CVS and Kroger have all launched clinical trials divisions in the last two years.
The pharmacies say they're focused on making clinical trials more convenient and diverse and improving health outcomes for their customers.
"If you see the trial is at an academic institution that's 30, 40 miles away, you're going to say, 'Forget it. It's too far,'" Tandon told CNET. "But if you can go to a Walgreens that's maybe five miles away, you're more likely to participate and complete the trial."
But there's no guarantee of success: One major player has already canceled its clinical trial program. And the retailers' paid partnerships with major pharmaceutical companies may raise questions about patient privacy.
Typically, the pharmacy will reach out to a customer who's opted in to receive communications and who meets initial testing criteria. If they're interested, the participant will come into the nearest branch that's set up with a clinical trial center and be given more details and a prescreening evaluation.
Once the trial begins, the patient may undergo diagnostics and have blood drawn at the pharmacy. Depending on what the client company has requested, they may be given wearable digital devices to monitor them at home.
Dr. Amir Kalali, a physician scientist and co-founder of the Decentralized Trials & Research Alliance, says retail pharmacies also have the advantage of an existing relationship with the customer.
"That can make the difference in building trust," Kalali said, "when you're getting someone to understand what's involved or trying to have them follow through and complete a trial."
Increasing diversity in clinical trials
Building on a pharmacy's customer base has another benefit: Pfizer, Gilead and other biopharmaceutical companies are eager to diversify their patient pool. Though less than 60% of the US population is white, white people make up 75% of clinical testing participants, according to data from the FDA.
Black, Hispanic and Asian people are all underrepresented in medical research, even though 20% of drugs demonstrate some difference in response among ethnic groups.
And even though more than half of cancer patients are women, only 41% of participants in oncology trials are female, according to research published last year in Contemporary Clinical Trials.
Advocates have called for better representation for years. Passed in December as part of the 2023 omnibus spending bill, The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act requires researchers to have a strategy for introducing more diversity into their recruiting efforts. With thousands of locations, the big pharmacies say, they can leverage both their convenience and their ability to reach underserved groups.
When Walmart launched its Healthcare Research Institute to begin trials in October 2022, it declared that the focus would be on "innovative interventions and medications 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 neighborhoods that lack 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 everyday essentials," John Wigneswaran, Walmart's chief medical officer, told CNET via email.
"We are already in our local communities," Wigneswaran added. "We have relationships with thousands of customers and are able to take our approach as a trusted voice in the community."
Wigneswaran said Walmart is initially focused "on chronic conditions, such as diabetes, cardiovascular disease, COVID-19 and asthma," but that additional diseases, including HIV, dementia and obesity, are also on its radar for future clinical trials.
Taking clinical research out of the lab and into the neighborhood drugstore is a big step, according to Moe Alsumidaie, founder of CliniBiz, which works to make studies more efficient and affordable. Staff have to be trained and the pharmacies themselves need to be outfitted with private exam rooms and specialized research equipment.
"It's not like sitting in a chair and waiting for your vaccine to be administered," Alsumidaie said. "Clinical trials are much more involved."
Of course, the pharmacies are well compensated for their efforts. Tandon described Walgreens' clinical trial program as "a fully baked revenue-generating business model."
"When a manufacturer reaches out to Walgreens, there's a menu of services they can pick and choose from," Tandon said. "And there's a fee structure involved."
To create a list of candidates, pharmacies mine data they have about their customers' age, gender and medication history. They don't keep records on race or ethnicity, but knowing a customer's address can help narrow their demographic information.
Walmart's Wigneswaran said that securing protected health information and maintaining trust with patients "are top priorities."
And according to the FDA, retail pharmacies are subject to the same regulatory requirements as any other research facility.
"The FDA may conduct inspections to ensure that trials conducted in retail pharmacies are conducted in accordance with regulatory requirements, including those pertaining to the protection of the rights, safety, and welfare of trial participants," the agency told CNET in an email.
To support the expansion, the US Food and Drug Administration released additional draft guidance in May.
Kalali said concerns about privacy are really part of a larger conversation.
Customer information "is already being sold by pharmacies to lots of data aggregators," he told CNET. "People are monetizing patient data as we speak. I don't believe decentralized trials at pharmacies are any different in terms of how we treat patients' information. The real question is, 'Should patients own their own health data?'"
The future of decentralized clinical trials
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 candidates for a study on gut health and its impact on colorectal cancer.
According to the American Cancer Society, African Americans are about 20% more likely to get colon cancer compared with the general population, and about 40% more likely to die from it.
The supermarket chain declined to comment about its program, but in a release, Kroger Health's chief commercial officer, Jim Kirby, said the cancer trial will be the first of many "that will utilize us as an alternative to the traditional clinical trial and research organization model."
Walgreens, which launched its clinical trial business in June 2022, has about a dozen studies in various stages of development. One that's made headlines involves the antibody PRX012, which has been fast-tracked by the FDA as a potential treatment for Alzheimer's disease.
In all, more than 2 million Walgreens customers have been contacted about participating in clinical trials, Tandon said, and the chain has already seen a positive trend in recruiting diverse participants: By June 2023, African Americans represented 17% of patients it had enrolled in clinical trials, while Latinos accounted for 15%.
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CVS Health was the first to launch a clinical trials program, back in May 2021. But the nation's largest pharmacy chain has already announced it's getting out of the business after just two years. It expects to fully phase out its services by the end of 2024.
Asked why, CVS said only that, "We continually evaluate our portfolio of assets to ensure they are aligned with our long-term strategic priorities."
The clinical trials business isn't for everyone, Alsumidaie said. It's a highly regulated industry that involves lots of institutional oversight, careful storage of sensitive information and the potential for adverse reactions among patients.
But CVS' decision shouldn't be taken as a sign it isn't a viable avenue, he added.
"It could be due to a variety of factors -- strategic realignment, competition, operational hurdles, financial implications and different industry trends," Alsumidaie said.
Kalali is also optimistic about pharmacy chains' future involvement in decentralized clinical trials. The goal, he said, isn't to replace traditional test sites, but to give patients options.
"What we'd like to see is a situation where some things you have to go to a physical location for, and other things you can be assessed at home," he said. "That's what we're really aiming toward: for patients to fit a trial into their lives, as opposed to them having to fit into the protocol."
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.What is the meaning of clinical trials? ›
What is a clinical trial. For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials.What are clinical trials designed to answer specific questions about? ›
Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.What is the importance of clinical trials in new drug? ›
Results from clinical trials can help identify factors that make the treatment work better for some people (including older or younger people) or cause more side effects. For example, children are not just 'small adults' – clinical trials can be used to see whether a treatment is both safe and effective for children.What is the role of a clinical trial pharmacist? ›
They should participate in the feasibility of the trial at the site, site selection visit and site initiation visit. Once the trial is ready to commence, responsibilities include supply ordering, handling, storage, dispensing, accountability and destruction in accordance with the current approved trial protocol.What are the 4 types of clinical trials? ›
- Pilot studies and feasibility studies.
- Prevention trials.
- Screening trials.
- Treatment trials.
- Multi-arm multi-stage (MAMS) trials.
- Cohort studies.
- Case control studies.
- Cross sectional studies.