CVS Health Wants To Be Your New Clinical Research Site
By Ed Miseta, Chief Editor, Clinical Leader
CVS has been a well-regarded and recognized healthcare brand since the company was founded in the early sixties. The company started as a pharmacy but has since migrated into a recognized and trusted healthcare company. Current CEO Karen Lynch is hoping to expand the relationship that CVS has with patients by moving closer into primary care.
“Clinical trials are a natural extension into healthcare,” says Josh Rose, VP, head of decentralized clinical trials, site solutions, and strategy for CVS Health. “We believe that move makes a lot of sense. We have all the right assets to enter this space, including data, investigators, nurses, and health clinics in the community.”
“Companies needed to conduct large trials on the vaccines they were producing,” says Rose. “We were in the communities sponsor companies needed to reach, and we had access to patients. It is easy for patients to access our locations and we have strong brand affinity. We learned that patients feel comfortable being involved with clinical research in their CVS location. Not surprisingly, we also learned they feel better about participating in clinical research with CVS than in a traditional facility with an unknown investigator.”
Pharma Needs Help
The interactions with patients over COVID vaccines helped focus the company’s work in clinical research. The company has since expanded its presence, and Rose now believes the company is a full-fledged player in clinical research.
“Several factors have enabled us to grow our footprint,” he says. “The access we have to patients is obviously a huge one. I have been involved in clinical research for 13 years. I hear pharma companies talk about their difficulties reaching diverse patients and getting them enrolled in trials. I feel these companies will often go back to the same sites they have used in the past. Oftentimes, certain patients can’t visit those sites because of jobs, families, distance, or transportation. CVS has the advantage of being in every community across the country.”
A shift is certainly taking place in the industry regarding delivery of care. In the past, patients tended to have a strong relationship with their doctor. Rose believes there has been a shift away from that relationship with a physician and towards urgent care, primary care, and telemedicine. This is causing a shift in how patients interact with healthcare providers and acquire medicines. Today, people will get treatments in a way that is convenient for them. Although that shift is happening in healthcare, Rose believes the same shift is happening in clinical research. It started with the pandemic when sites were closed and sponsors needed to continue studies.
That shift was needed because of general enrollment challenges and low percentage of minorities opting to participate in clinical research in particular. That lack of diversity has needed a transformative model to deliver clinical research.
“CVS is actively engaged with multiple large and mid-sized pharma companies about this shift towards community-based trials,” states Rose. “CVS has 9,000 retail pharmacies that, on average, are located around 10 minutes from 85% of the U.S population. CVS also has approximately 1,000 MinuteClinic locations in the U.S. Each MinuteClinic provides in-person and telehealth visits and are places where CVS customers could receive essential services such as vaccines, camp physicals, and treatments for sunburn and poisonous plants.
“We're taking a portion of those MinuteClinic locations and converting them into trial-ready research sites,” states Rose. “If patients want to participate in clinical research, they no longer need to travel an hour or two to a remote location to see an investigator they do not know. Today, they can walk into a community CVS they know and trust. It is convenient and familiar, and minority patients are more likely to see an African American or Latino caregiver.”
Transformative Not Disruptive
Will CVS Health’s more prominent presence in the clinical space be disruptive to the industry? Rose does not think so. In fact, he notes he does not care for the word, believing it implies negative results.
“We don't view what we're doing as disruptive,” he says. “We view it as transformative, and there is a difference. Disruptive means you are killing the old model and putting a new one in place. But transformation arises from innovation. Transformation means moving towards a higher plateau where we can deliver care better. Research has found that 60% to 65% of patients want to participate in clinical research, yet less than 5% of eligible patients do. By entering this space, we are not skewing patients away from other sites. We are providing alternatives for patients who could not access the other sites. Our patient database has over 130 million individuals. For those patients, we are not shifting access, we are expanding access.”
While patient recruitment will be a significant aspect of the CVS clinical model, that model has three core capability areas. The second is the community trial solution business, which involves the MinuteClinics that have been converted into clinical research sites. Home research and nursing assets will be leveraged with those sites. COVID-19 has garnered the most attention, but CVS has also been involved in trials for respiratory, cardiovascular, and neurology. Studies involving highly invasive procedures or complex assessments would not be a good fit, but Rose notes most studies do not involve those.
The third area is a real-world evidence (RWE) business. “I believe we have the largest patient database in the U.S.,” states Rose. “That is because of our assets, the relationships we have with patients, and our pharmacy and Aetna healthcare plan. We know who those 130 million patients are, what meds they are on, what scripts they are getting, and what claims they have in the Aetna database. By linking that information with EHRs we can also gain information on diagnostic. When that information is deidentified, it can provide researchers with valuable real-world data (RWD).”
That information can be coupled with a license to contact patients. When CVS reaches out to them, Rose believes patients will be more likely to respond to the request. Patients can be asked about participation in a study, as well as inclusion/exclusion criteria. That will allow CVS to determine available populations. Once a new drug is approved by regulators, patient records will be able to collect information on adverse reactions, behavior, and use of the drug in an efficient and anonymized manner.
“We started this business a year ago and have already engaged with over 18 million patients and enrolled 17,000 of them into clinical research,” says Rose. “We can set up a registry of thousands of patients. Pharma can then come to us with a certain drug that they want to explore. They might want to understand a specific aspect of it, such as how it is being used, the safety profile, or how it compares to another drug. We can assist them by setting up a registry or an RWE study where we collect data in a way that is non-obtrusive and contributes to advancing healthcare beyond just a randomized control clinical trial.”
Patient trust is important to CVS and Rose notes it is something the company takes very seriously. The reputation of CVS is the company’s most valued asset and something the firm will go to great lengths to protect. CVS has the expertise required within the company to ensure that anytime patient data is used, all approvals and legal requirements are met.
“We will continue to see a shift towards community based clinical research,” he adds. “Two main challenges in clinical research are site identification and access to patients. CROs spend a lot of time trying to manage those challenges. A lot of effort goes into it, often with poor results. We know one in two studies will under enroll patients. Even when a site does enroll the promised number of patients, there can be high drop-out rates. CVS has control over both the sites and the patients, and we can mitigate a lot of the risk associated with clinical research. We believe we can enroll patients in a way that is human centric and appealing to patients. Ultimately, this will drive down the cost curve associated with study startup. We believe that will help transform the clinical trial industry.”