By Deborah Borfitz  

May 23, 2023 | Last week, CVS Health announced its intension to phase out of the clinical trial business with a full exit expected by the end of 2024. The word on the street is that the news came as a complete surprise to affected colleagues, some of whom have already been let go. 

Jill Pellegrino, vice president of recruitment and real-world evidence at CVS Health Clinical Trial Services, was a guest on The Scope of Things podcast only a few months ago. She spoke about the retail giant’s wherewithal to increase patient recruitment efforts, encourage equitable participation, and conduct real-world data analysis, and how the company had ambitions to become a one-stop shop for clinical research services.   

In a prepared statement, CVS Health shares with Clinical Research News that the move to close its clinical trial unit comes in response to an ongoing evaluation of the company’s portfolio of assets to ensure they are aligned with long-term strategic priorities. “We’ll work with our trial sponsors to ensure a smooth transition, as well as continuity of care and minimal disruption for patients,” it reads. “In parallel, we’re working to support impacted colleagues, and will provide career transition support for those unable to find another role within CVS Health.”  

Not everyone was shocked by the revelation, least of all the founder and CEO of RxE2, a community-based decentralized trial technology company aiming to give pharmacists their rightful seat at the clinical research table. A longtime skeptic of the approach being taken by the big-box stores, Gerald Finken was likewise on an earlier episode of The Scope of Things speaking about the value of having community pharmacists—who already spend most of their time out in front of the counter—recruit participants as well as dispense investigational medicinal products.   

While the news that CVS plans to leave the clinical trial space was disappointing, says Walgreens Chief Clinical Trials Officer Ramita Tandon, she applauds her colleagues there for being the first mover. She is also reassuring internal and external stakeholders that “we are not going away.” 

It has been barely a year since Walgreens launched into the clinical trial business with a singular focus on increasing access and retention in sponsor-led drug development research. But “we’re walking before we’re running” with a fully compliant operating model backed by a team with decades of experience in clinical research. The protection of research integrity and patient safety have been top concerns as trials have been brought into the organization, Tandon tells Clinical Research News.  

Just-In-Time Model 

The clinical trial business unit of Walgreens launched with three verticals, the first requiring a big investment in technology to match patients in the Walgreens ecosystem to clinical trials on behalf of partnering drug manufacturers, government agencies, and healthcare systems, says Tandon. This is done with precision using social determinants of health and by aggregating patient pharmacy and clinical records. 

“We want to ensure we are finding the right patient populations, particularly patients that are in communities of color or in communities of high unmet needs” says Tandon. “That has been our north star because only 5% of people in this nation participates in clinical trials.” 

Walgreens has also been judiciously converting some of its retail locations into fully equipped clinical trial centers—12 to date in California, New Jersey, and in several spots in the Deep South and Midwest (the full list will be shared on a soon-to-launch website)—where trial participants can go for low-acuity study visits such as their screening phlebotomy. The centers serve as “educational hubs...  a welcome entry point for customers and consumers to come in and learn the basics of a clinical trial and feel comfortable and empowered that they can make the decision,” Tandon says.   

In addition to on-site study visits, Walgreens can deliver home health services for hybrid-model trials thanks to its acquisition of CareCentrix. But when it comes to making trials available and convenient, “it’s not a one-size-fits-all strategy across our communities,” she notes. In parts of the Deep South and Midwest, for example, system-level barriers exist in accessing broadband. 

Perhaps the only substantial difference in Walgreens’ approach to the clinical trial business is that it is expanding a lot slower than CVS to unlock the physical infrastructure for expanding trial access, says Tandon. Walgreens is using a just-in-time model whereby it builds clinical trial centers in locations where study sponsors want to enroll participants, so sites aren’t sitting idle. 

When people bring up CVS’s closure of its clinical trials segment, Tandon says she reminds them that Walgreens has been actively involved in the development of Food and Drug Administration (FDA) guidance on decentralized clinical trials to ensure it addresses retail pharmacies. Partners looking to bring trials to the company can be assured that it is with the full support of CEO Rosalind Brewer and the board of directors.   

‘Treading Lightly’ 

CVS and Walgreens are to be thanked for opening opportunities for pharmacies to start working with study sponsors, says Finken, noting that both companies have hired top-notch talent. But clinical trial services represent “a small drop in the bucket” of their overall business which is largely being vertically integrated into healthcare, CVS Health with Oak Street Health and Signify Health and Walgreens with VillageMD.  

The dealings reflect efforts to offset a drop-off in foot traffic, over-the-counter purchases, and declining profits from filling prescriptions due to lower reimbursement rates and the growing popularity of ordering drugs by mail, says Finken, referencing Amazon’s launch of a digital drugstore in 2020. The following year, CVS announced it was closing almost 900 stores through 2024, or around 10% of its pharmacies, which he views as “writing on the wall that it really needs to rethink its pharmacy strategy.”  

It remains to be seen how things shake out for Walgreens, he says. In 2020, Walgreens’ parent company announced that it would co-locate between 500 and 700 primary care clinics at its stores through 2025 with the intention of building hundreds more thereafter. CVS Health now has more than 1,000 in-store MinuteClinics, and the staff consists primarily of nurse practitioners.  

Healthcare is complicated, heavily regulated, and has a staffing shortage, as has been most publicly exhibited by the short-lived Amazon-Berkshire-JPMorgan venture intending to lower costs and improve outcomes. Google Health and Amazon are therefore “treading lightly in this space,” says Finken.  

And so is RxE2. The long-term goal is to have independent community pharmacies serving as clinical trial sites, he says, but since that’s a “heavy lift” the starting point is engaging them in the areas (i.e., recruitment and dispensing of drugs) where they already excel and have the bandwidth to do it now.   

Accelerating Interest 

Walgreens already had a half dozen contracts signed when it announced it was in the clinical trial business last year, says Tandon, and interest has been accelerating ever since. One big motivator has been the recent federal mandate requiring diversity action plans for clinical trials used by the FDA to decide whether drugs are safe and effective.  “Industry now has to be mindful of making sure they have a diverse patient population [in studies], so that has been a big boon for us,” she says. “Virtually within an hour we can tell you where those patients are located by zip code and by race and ethnicity.”  

Even at traditional provider sites, clinical research is not easy to do well, continues Tandon, referencing concerns about study conduct. “We recognize where our strengths are, and we can partner with healthcare systems... [and] even with clinical trial sites that are already up and running. We’ve already said we are not going to do this alone ... and if that means standing up a clinical trial site next to a healthcare system and allowing patients to go to Walgreens to get the easy visits done ... that’s what we’re doing.” 

Walgreens is also being intentional about “learning along the way” and retooling the approach as needed, she adds. The learnings will come not just from quantitative information about how well the operating model is working but qualitative data as measured by surveys about the patient experience. “We want to understand if this a good experience and if [participants] are feeling more comfortable to the point that they start to talk to others about doing clinical trials here at Walgreens.”   

The company has already made some significant investments aimed at removing some of the administrative burdens on pharmacists, so they can start to focus on patient care, Tandon says. “The same goes for clinical trials.” 

The workflow at present works like this: When patients picking up a script get flagged for a clinical trial, a trained pharmacist or pharmacy tech will inquire if they’re interested in participating. If so, either the conversation will immediately move to a private space in the store, or the individual will call back later and may also opt to learn more about the study by using a QR code on their prescription bag, she shares. 

Of course, not all clinical pharmacists are looking to expand their scope of practice in this way. But those who are interested must go through training on ICH-GCP guidelines and mock simulations of trials before employing their newfound skills, Tandon says. “There is a lot of excitement within our pharmacy base... [because] they get to do more and introduce potential new therapies to patients that might actually advance their health outcomes.”