This month Prothena announced a partnership with Walgreens to boost patient enrollment in an Alzheimer’s clinical trial, aiming to hasten the approval process for its anti-amyloid antibody. In partnership with the pharmacy, Prothena said it hopes to wrap up the first stage of the Phase I trial and release topline data at the end of 2023.
It’s the latest in a string of collaborations between biotech companies and U.S. pharmacy giants in recent years. The pharmacies say their infrastructure and vast troves of patient data can reach larger, more diverse patient cohorts, helping biotech and pharmaceutical companies to fill trials faster, avoid costly delays and right the pronounced inequities in clinical trial enrollment.
“The industry’s current clinical trials model is antiquated and in crisis,” Walgreens Chief Clinical Trials Officer Ramita Tandon told BioSpace via email, citing an “urgent need to diversify patient populations.”
Diversifying Patient Pools
CVS was the first pharmacy to enter the clinical trials space when it launched its Clinical Trial Services in 2021. Walgreens followed, announcing its Health Research Initiative in the summer of 2022. Rival Walmart launched the Walmart Healthcare Research Institute in October of the same year, and most recently, Kroger opened a clinical trial site network in January 2023.
These pharmacy chains can access more extensive and distributed patient prescription and diagnostic data pools than a typical healthcare provider such as a hospital or clinic. CVS Health, for example, has access to health data from 100 million patients, including claims data from insurance company Aetna. These data can, in turn, serve as the basis for targeted recruitment campaigns, the pharmacies note.
“If a patient has a prescription history or if you are an Aetna member and have claims data, we would access that information in order to outreach to you,” Omar Abdelsamad, executive director of CVS Health Clinical Trial Services, told BioSpace.
Carri Chan, a healthcare operations management professor at Columbia University, agreed.
“Pharmacies certainly have a strategic advantage relative to how clinical trials have historically been run,” she told BioSpace. “Pharmaceutical companies are happy to partner with them to be able to reach a broader population.”
Retail pharmacies charge partners for clinical trial services, but it’s unclear how much. Walgreens Communications Manager Steven Cohen told Biospace the company is “not currently sharing specific revenue information on our partners.” CVS has also not disclosed the profit model for its clinical trial services.
Such services can be invaluable for biotech and pharma companies needing to fill trials promptly. According to a 2020 study, 80% of clinical trials fail to meet the enrollment target and timeline, resulting in a loss of revenue of up to $8 million per day across the industry. A 2018 analysis showed that the single highest reason for trial termination, at 55% of total trials, is low patient enrollment and retention.
Pictured: A CVS pharmacy in Sunnyvale, CA, located inside a Target store / Adobe Stock, Sundry Photography
Pharmacy partnerships could also help companies diversify their historically biased trial populations. A 2021 study found that 5% of Americans participate in clinical trials, and as recently as 2020, 75% of clinical trial participants were white. Starting last December, the passage of the 2023 Omnibus spending bill’s DEPICT Act now requires that entities running clinical trials have a plan to recruit diverse participants.
In addition to aligning with federal regulations, Hideki Garren, chief medical officer at Prothena, told BioSpace that “what’s really important for both Walgreens and us . . . is to make sure that patients enrolled in Alzheimer’s studies are representative of the diverse population of Alzheimer’s patients.”
Retail pharmacies have emphasized their access to rural communities and communities of color as part of their services. Almost half of Walgreens’ pharmacies are located in “socially disadvantaged communities,” Tandon said, making Walgreens well-positioned to diversify enrollment. In October 2022, Walmart announced similar goals.
Although Chan agreed that these partnerships are one way to reach a diverse cohort, she said there are additional important steps to increasing diversity in clinical research.
“We need education in communities so that . . . they know [clinical research] is an option for them,” she said. Patients also need to feel that their health “is the priority when they’re participating in these trials,” she continued, “so it is important to also partner with physicians that can help build that trust.”
Tandon added that Walgreens could leverage the trust between pharmacists and community members to facilitate enrollment. Walmart and CVS have also emphasized the importance of such trust in patient recruitment.
Because these companies have a daily presence in patients’ lives, there is likely truth to this, Chan said. However, clinical trials are often for people with severe diseases who have few other treatment options.
“I think the person who is going to be most important in building that trust is their local physician,” she said.
Although, in some cases, patients’ regular physicians will not always be critical in the clinical trial process, Tandon said, as retail pharmacies can directly collect clinical trial data in their clinics and via telehealth. Pharmacies are often more accessible to patients in some rural areas without access to a hospital or clinic, which can facilitate clinical trial retention, she noted.
A Booming Industry
Some clinical trials are not well suited for the retail pharmacy model. Retail pharmacies can only sometimes recruit for trials that need to be run in inpatient hospitals, for example. But there is the potential for significant financial gain for those that are.
The drug developer typically foots the bill for running the clinical trial, but faster enrollment can allow firms to bring their drugs to market faster—and start earning sooner.
“We’re hoping that this will accelerate enrollment,” Prothena’s Garren said. “Over time, we hope the partnership will evolve to allow us access to a more diverse pool of patients that can go on to our larger, next-stage study.”
As such, pharmacy partnerships have become increasingly common. Abdelsamad said CVS has partnered with “over 25 pharma organizations.” Walgreens announced in its fiscal 2023 fiscal year second-quarter earnings that it has signed its first five clinical trial contracts. And in a statement, Walmart disclosed that it has a wide range of study partners, including clinical research organizations and academic medical centers.
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