Government Contract Advances Walgreens In Clinical Space
By Dan Schell, Chief Editor, Clinical Leader
The pack of pharmacy chains racing to enter the clinical trials space looked a little different the last time I spoke with John Campbell of Walgreens in January 2023. Since then, CVS has dropped out, Walmart has closed its Walmart Health centers and Walmart Health Virtual Care (although the company’s Healthcare Research Institute will still help with clinical trial education and engagement), and Kroger Health has entered the race and continued to recruit patients. But if Walgreens wasn’t in the lead with its existing 35+ clinical trial contracts, it surely is now after it landed a $25 million deal with BARDA (Biomedical Advanced Research and Development Authority) at the end of July. More importantly, this kind of government contract almost ensures Walgreens won’t be making a hasty exit a la CVS any time soon. Campbell, the company’s head of DCTs, filled me in on some of the details of this big announcement.
BARDA STUDY DETAILS
The “Pharmacy Study,” as BARDA refers to it, is a Phase 4 observational trial that will use COVID-19 vaccine data to determine how well a vaccinated person will be protected from future infections. It will also help researchers understand what patient participation and retention will look like in this environment. Walgreens will use 20 sites — some existing and some new — in seven states to conduct the 12-month trial. The study will enroll up to 4,000 participants.
“We will contact patients who have been vaccinated at Walgreens in the past, and we will notify people who sign up for vaccinations at Walgreens who live within certain distances of these particular sites that they're eligible to participate in the study after they receive the vaccine,” Campbell explains. “After consenting, at the baseline visit we will do a blood draw and ask a few simple questions like those related to medical history and demographics. They'll come in a few more times during the next 12 months for follow-up visits and each time we'll do a simple blood draw. Beyond that, we will monitor symptoms to see if people who receive that standard of care vaccine have a breakthrough case of COVID, and then off of that, we'll look at correlates of protection.”
WHO HAS OVERSIGHT?
“Is a pharmacist running this study?” Campbell says that’s one of the most common questions Walgreens gets about any of the trials in which they are involved. Of course, the answer is no; they have PI oversight from an MD on an interventional study, which usually includes a sub investigator and a CRC on-site all working together as a unit — much like a traditional site. “Often they are working directly with the pharmacy teams,” Campbell says. “If we have a need for pharmacy services, we will involve the pharmacy, but for now, most of our efforts have been focused on our retail pharmacy infrastructure and the clinical space that we have available within that infrastructure.”
The BARDA study has a hybrid site model. There is a PI in charge of protocol development who has oversight of the scientific part of the study. There is also a site investigator team that includes the investigator and sub investigators and staff who perform the blood draws.
WHAT ABOUT MORE COMPLICATED TRIALS?
Campbell says internally they refer to his division as Walgreens Clinical Trials, which has about 70 employees and over 100 if you include contractors. This division will sometimes act as a sort of recruitment vendor, working to send patients to other sites where the therapeutic areas being studied might not be the best fit for a retail pharmacy. For other studies, they may create a very traditional-looking site network, while in others they may provide a full range of services acting as the site and the CRO.
As an emerging player with such a breadth of expertise, Campbell says Walgreens also is frequently asked about its the ability to handle oncology trials. The question usually revolves around finding ways to lower the burden of participation by offering more convenient ways to access a site. These scenarios often involve patients in that longer-term, follow-up period of a study where they may just need to come in every other month or even once a quarter to do a simple sample collection and answer a questionnaire.
“It's not something we have in place now, but as we think longer term, I think there are more ways we can enable conduct across a broad range of study types. In some, like this BARDA study, we're able to do everything — we can be the site, we can be the CRO, and even write the protocol. But in other areas, we know there are portions that will never make sense for us to do.”
Like all of these retail-based players, Walgreens is counting on the scope of its nationwide site network to not only increase participant access to trials, but more importantly, ensure more diversity. This BARDA study is bound to test the limits of each of those metrics.