Walgreens’ Decentralized Clinical Trial Future
By Allison Proffitt
August 4, 2022 | In June, Walgreens launched its clinical trial business in an effort to combine the company’s vast foundation of patient insights, partner-enabled health and technology capabilities, and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.
The clinical trial business has necessitated new hires and in late June the company introduced the Walgreens Clinical Trials leadership team comprising Ramita Tandon, Chief Clinical Trials Officer; Kendal Whitlock, Head of Digital Optimization, Real World Evidence Clinical Trials; John Campbell, Head of Decentralized Clinical Trials; Liam Wood, Head of Product, Clinical Trials; and Adam Samson, Head of Clinical Delivery Operations, Clinical Trials.
Samson gave Clinical Research News an overview of Walgreens’ clinical trials vision. Historically, Samson said, Walgreens has used mailers for some trial recruitment, but hasn’t participated in trials much beyond that.
He credits the COVID-19 pandemic—and Walgreens’ new CEO, Roz Brewer who joined in March 2021—for some shifts in thinking. Brewer has pushed Walgreens into healthcare spaces, and the COVID-19 pandemic highlighted Walgreens’ valuable role in community healthcare, Samson said.
“We had a big role in administering vaccines—about 63 million covid vaccines were administered by Walgreens,” he explained. “With COVID-19, there was a lot of misinformation or at least a lack of understanding about where to go for the right information. So if you have a trusted relationship with somebody like a pharmacist that you go to see multiple times a month or even a week, that’s a place where [people went for reliable information].”
Samson expects that existing relationships Walgreens staff have with patients in local communities will serve as strong foundations for growing a clinical trial business. “I think that there’s a lot that can be done to provide a grassroots education about clinical trials, to lay that foundation serving the patients that are there,” he said. Walgreens can play a unique role, he believes, in not only alerting patients to available trials but overcoming lack of understanding about trials and lack of trust in the process. “This is our way to educate and empower. I’ve learned, since I’ve been here, that we actually did a lot of that during the pandemic with COVID-19 vaccines.”
Three Service Lines
The Walgreens Clinical Trials team plans to rapidly scale three “portfolio-integrated, patient-centric” service lines: patient recruitment, real-world evidence and informatics, and Trials to Patients.
For patient recruitment, Walgreens plans to link their extensive patient prescription data with clinical data through a partnership with Pluto Health, a multi-layered, smart care coordination service that unifies siloed health information from multiple places (such as medical records, social determinants of health, insurance claims, and more). The Pluto Health team evaluates patient health information with the recommended clinical care guidelines and social determinants of health data to identify and close any potential gaps in care. Walgreens plans to use this clinical big picture to aid in trial recruitment: “to match diverse patient population that we have to clinical trials.”
Walgreens also plans to use their same datastores to offer real world insights to sponsors for drug development strategies and clinical trial design. “We want to take a very tech-enabled approach and really leverage the data was have, but do it in a way that is highly compliant, and in a way that doesn’t breach the trust or privacy of the patients that we have.”
Finally, Walgreens envisions their physical locations—nearly 9,000 across the US, as the ideal location for hybrid and decentralized clinical trials.
This is the service line that Samson will champion. In July 2020, the company expanded a partnership with Village MD, a primary care provider to be co-located in 500-700 Walgreens stores over the next five years with a home care business as well.
At other Walgreens stores, “Health Corners” have been set aside staffed with registered nurses or registered pharmacists to answer questions about medications, manage ongoing health concerns, explore digital health solutions, and more. “These already exist and have been growing in number over the past year,” Samson explained about the Health Corners. “This is an ideal opportunity to add on top of that this option to our patients of clinical trials within the Health Corner locations.”
Flexibility and Optionality
Samson says Walgreens locations should be able to accommodate, for example, blood draws, blood pressure readings, EKGs, assessments for patient-reported and clinical-reported outcomes. He also says Walgreens can coordinate telemedicine or video calls as well as going to patients’ homes.
“It’s about the providing that flexibility and optionality that so many in our industry are talking about right now using Walgreens locations as that bridge,” Samson explains. “Depending on the nature of the study, you might be able to do a number of the visits right there in the Walgreens, or all of them. Or if it’s a highly complex study, Walgreens could be used for a set number of visits.”
Samson says the substantial number of Walgreens locations gives the company a leg up in centralizing many capabilities, handling project management, and responding to complexity. But he knows that successful clinical trials still mean working closely with sponsors to make sure protocols are written with flexibility.
“We’ll have to remain flexible in our approach to be able to offer a range of different services. We don’t necessarily need to outfit 9,000 stores overnight to be able to be really great provider of clinical trial services.”
Samson plans to survey available staff and resources across portfolio of locations, so that when a sponsor comes with a particular trial, he can quickly identify the right locations for those needs. “We know that diversity is something that—for a very good reason—is very important to our industry,” he adds, highlighting Walgreens’ ability to reach into communities that are otherwise “medical deserts”.
Samson predicts the first Trial to Patients locations to be up and running in months, but that the team will grow quite quickly.
“We want to do this thing right. I’ve been very pleased since I joined Walgreens to see that the focus here is making sure that we keep our key constituents in mind: our patients, making sure we can bring these options to them,” Samson says. “We want to build a business on top of our existing foundation, but at the same time, we’re not going to be taking on anything beyond what we’re capable of at each step.”