CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
“It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there's a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care.
The company was one of the first retailers to launch a clinical trials unit in 2021, and was soon followed by competitors like Walgreens, Walmart and Kroger. They touted increased access to clinical trials, which is a frequent challenge for studies.
According to the Health Information National Trends Survey, only about 9% of Americans had ever been invited to participate in a clinical trial, though almost half of them chose to join once asked. In 2020, 41% said they didn’t know anything about clinical trials.
Recruitment could be one area where retailers could excel, Kaganoff said. The longer it takes to recruit for a clinical trial, the more time a pharmaceutical company needs to bring a product to market.
“Being able to use a retail channel where folks are showing up anyway for their pharmacy needs or for their care is a good way, particularly for trials that are relevant to a large portion of the population. Folks who may not be considering a trial necessarily could come in through that door,” she said.
Studies also struggle to recruit participants from diverse backgrounds, which can limit treatments’ effectiveness with underrepresented groups.
Research published last year in the Lancet found only 43% of U.S.-based trials between 2000 and 2020 reported any race or ethnicity data, though reporting did increase over time. White patients were overrepresented compared with their share of the population.
Drug and device makers will eventually be legally required to submit diversity action plans to the FDA detailing the sponsor’s enrollment goals for the study and how they plan to meet them.
Chris Lew, an engagement manager on Rock Health’s consulting team, noted Kroger’s first trial with Persephone Biosciences is working to find microbiome-based biomarkers that could signal colorectal cancer.
“African Americans are about 40% more likely to die from colorectal cancer than other racial groups. And so that's kind of a key example of how the retail model can really deliver on some of the diversity and inclusion challenges that the space has really lacked and failed to address,” he said.
Retailers could make inroads in studies with high attrition rates — for example, where participants face long travel times to academic medical centers or for non-life-threatening diseases that might not motivate patients to continue with an inconvenient trial.
But clinical trials could also be a difficult space to enter even as retailers bulk up their care delivery operations, said Christopher Lis, managing director of global healthcare intelligence at J.D. Power.
“I believe this will be a challenging space for retail healthcare to achieve great success due to the competitive nature of the clinical trial marketplace, the requirements for appropriately trained clinical trial staff, coordination with providers, sponsors, [contract research organizations] and others, and other operational and regulatory complexities related to coordinating these trials,” he wrote in an email.
Those operational challenges may have contributed to CVS’ decision to shut down the clinical trials unit, Lis said. The healthcare giant is also working to integrate its recent acquisitions of home care company Signify Health and primary care provider Oak Street Health.
“Big picture, it probably came down to strategic focus, economics and operational complexities that pivoted CVS to a different place at this time in their evolution,” Lis wrote.
A CVS spokesperson told Healthcare Dive last month it continually evaluates its portfolio “to ensure they are aligned with our long-term strategic priorities.”
Rock Health’s Kaganoff said there’s a lot of digital innovation happening in clinical trials, including in patient engagement and data analytics. Retailers could take better advantage of those tools to improve the clinical trial experience.
“I think right now they're a little bit competing against both traditional trials as well as new decentralized clinical trials or other more digitally enabled trials,” she said. “And so saying, ‘You know what, we will be the best of all worlds,’ will probably give them an even better edge.”