CVS Health Banks on Trust to Increase Diversity in Clinical Trials

Enrolling clinical trials can be challenging. Ensuring those trials include a diverse set of patients exacerbates the difficulties, but also creates opportunities. CVS Health’s Clinical Trial Services eliminates the challenges for large groups of patients by providing trial sites within the community that already bear a trusted name and are staffed by people who – generally – reflect that community. That combination provides a level of trust and convenience that matters to prospective trial participants.

“Since launching our community-based Clinical Trial Services one year ago, CVS has reached out to nearly 20 million patients and has enrolled close to 20,000 patients into clinical research in more than 30 studies,” Josh Rose, VP, head of decentralized clinical trials, site solutions and strategy at CVS Health Clinical Trial Services, told BioSpace. CVS focuses on Phase II through IV clinical trials, enabling precision recruitment and the inclusion of real-world evidence in retrospective and prospective studies.

The clinical trial-ready sites can conduct patient exams for trials in “a great majority of therapeutic areas across a lot of protocols,” Rose said, mentioning vaccines, cardiovascular, metabolic, respiratory, dermatology and gastroenterology as examples. “What we can’t do are highly invasive procedures, like biopsies or endoscopies, or tests that require highly specialized equipment, such as CT scans.”

Historically, “Approximately 80% of clinical trials don’t reach their enrollment target, and fewer than 5% of eligible patients participate in clinical trials,” Rose said. “That’s because clinical trials tend to be difficult for patients to participate in. And, when patients are surveyed about their trust with fee-for-service sites or academic medical centers, about 60 to 70% of the responses are less than favorable.” When surveyed about participating in clinical trials with CVS, however, “The results are remarkably high. We actually get about 80% who say they view trials at CVS very positively.

“We have 9,000 CVS pharmacies in the U.S. We’re 10 minutes away from 80 to 85% of the U.S. population,” Rose pointed out. “On top of that, we have about 1,000 “Minute Clinics” (for simple medical care). We’re converting a substantial portion of those Minute Clinics into clinical trial-ready sites, which lowers the barrier for participation,” he said, offering convenience and familiarity, as well as a trusted brand.

Currently, CVS has 40 clinical trial-ready sites. By the end of 2022, Rose said he expects to have 80, and next year 150. The sites will operate as an integrated network, so the site in Dallas is the same as the site in Chicago or Washington, DC.

Rose said that by making trials more accessible, CVS is enriching the situation for the clinical trial ecosystem. “We believe this will improve the perception of clinical research and, therefore, benefit non-CVS clinical trials sites in general.”

The proximity of trial sites to patients absolutely makes it easier for rural patients to participate in clinical trials, but it also makes it easier for urban patients. “One of our priorities for our clinical trial business has been to open clinical research sites in densely populated urban areas that have high diversity…so urban areas like Chicago, Dallas, Atlanta and Washington, D.C. We’re seeing about 40% patient diversity in the work we’ve done so far.”

Trust among certain communities – with medicine in general and clinical trials in particular – is lower than average, so being able to participate in a clinical trial at CVS – “a familiar, trusted brand,” Rose said – eases that issue.

Furthermore, CVS tries to ensure that its staff reflects the community. “That means, for example, that if a site is in an African American community, there’s a really good chance our caregivers are from that community. Patients have an elevated sense of trust because now they come in and see somebody who looks like them, speaks like them and understands their characteristics and their culture,” Rose noted.

Outreach begins when CVS contacts patients who have expressed interest in participating in clinical trials with information about opportunities to enroll in relevant studies. “We spend a lot of time trying to simplify and improve patients’ enrollment experiences,” Rose said. At CVS, that means ensuring that the clinical research area in the pharmacy is easy to find, that enrollment is efficient and that it uses appropriate technology where that makes sense.

People may participate in trials by coming to a CVS pharmacy trial site, by using remote telemedicine technology for monitoring and consultations or by accessing its home research nursing component, in which a CVS nurse can visit patients at home for certain procedures or monitoring. “The whole thing is CVS-branded, so it doesn’t feel as if patients are interacting with three different entities,” Rose said. “Avoiding the siloed fragmentation that sometimes occurs in clinical research is important because that fragmentation is a reason some people drop out of studies.”

CVS Clinical Trial Services leverages relationships with its centralized and retail pharmacy business and Aetna health plans. That network enables access to a large database of patients (who have opted in). “That’s 130 million identified patient lives,” Rose emphasized. It includes data on patients’ diagnostics, procedures, prescriptions and geographic locations. Through tokenization, CVS is integrating this into electronic medical records. “We can leverage this database to help determine where we open sites for specific clinical trials, and also use it for outreach (based upon receiving the necessary patient permissions).”

The pharmaceutical industry has been very supportive of this approach, Rose said. “The need to shift toward community-based, human-centered studies resonates well with pharma,” because this helps them serve patients better. Now, he said, “We are actively engaged in conducting pilots and other studies with multiple large pharmaceutical companies.”