Pharmacy retail giant Walgreens looks to disrupt the clinical trials business

Walgreens' healthcare ambitions continue to grow as the pharmacy retail giant expands its reach into clinical trials by leveraging its vast trove of patient data, its technology assets and its retail locations. 

Walgreens aims to revolutionize the antiquated clinical trials model with an eye toward using its community reach to increase patient enrollment as well as racial and ethnic diversity in sponsor-led drug development research, executives said.

"We move into healthcare, and we're focused on creating consumer healthcare solutions in our local communities; clinical trials are sort of a natural extension of that vision overall," said Ramita Tandon, the company's new chief clinical trials officer, told Fierce Healthcare.

"We can leverage our clinical trials business as an opportunity to change the paradigm for the patient experience of participating in clinical trials and create more connectivity with patients and care," she said. "We have the ability to give our patients access to these trials in a way that they perhaps have never been tapped into before. One of our goals is to really help move the needle in trial participation."

Tandon described the clinical trials business as Walgreens' "next growth engine" of consumer-centric healthcare solutions.

Tandon said Walgreens is in "active discussions" with a number of drug manufacturers looking to launch clinical trials.

"We are working very closely with them to understand their business needs and create the solution that's going to be sort of bespoke to their specific trial needs. Our goal is to move that needle and start to see a larger number of U.S. patients participating and highly diverse participants that are coming into clinical trials," she said.

Last fall, Walgreens Boots Alliance, the holding company for Walgreens, debuted a revamped healthcare strategy with the rollout of Walgreens Health, a new business segment focused on consumer-centric, tech-enabled healthcare that ramps up the company’s capabilities in primary care, post-acute care and home care. The company also made hefty investments, to the tune of $5.2 billion, in primary care company VillageMD as part of the healthcare giant's strategic move to expand further into value-based primary care.

Tandon joined Walgreens eight months ago to build out the clinical trials business and brings leadership experience in the clinical trials and contract research organization markets. Her resume includes serving as chief operating officer at Trio Health, and she led commercialization and outcomes at CRO company Icon.

"I've spent about 25 years in the life sciences clinical trial space working with manufacturers on a regular basis as they were looking at ways to design and execute clinical trials differently. How do we leverage data technology and different modalities to engage patients to improve participation, and ultimately, improve the experience?" she said.

"When the opportunity at Walgreens presented itself, for me, it lends itself to my passion in this area and it's also a tremendous opportunity at a national scale to improve the percentage of patients across the U.S. who participate in clinical research. And, more importantly, improve the diverse nature of clinical trials," Tandon said.

Just 3% of the nation’s physicians and patients take part in clinical trial research that leads to new therapies, according to Food and Drug Administration (FDA) data. Nearly 80% of clinical trials fail to meet enrollment timelines, often contributing to costly delays.

The industry has also recognized the need for more diversity in clinical trials.

The FDA is taking steps to increase racial and ethnic diversity in clinical trials given that 20% of drugs have a variation in responses across ethnic groups, yet 75% of clinical trial participants are white, while only 11% are Hispanic and fewer than 10% are Black and Asian.

"The therapies that are coming out in the marketplace today are not very representative of the U.S. population. So for me, this afforded an opportunity to not only move the needle in participation but also start to see more diversity in clinical trials," Tandon said.

Tandon said the new business line combines Walgreens' 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.

Walgreens plans to rapidly scale three service lines with a focus on patient recruitment, bringing trials to patients and real-world evidence informatics, Tandon said.

"How do we help manufacturers identify patients in local communities that have never been tapped into? So, ultimately, matching patients from local communities to trials that are either getting started or ongoing," she said.

With most clinical trials research, patients shoulder the burden of driving to a trial site or physician's office to participate in the trial. To open up access, Walgreens plans to use its physical footprint as clinical trial sites, she said.

"If a clinical trial is happening and we can get a patient into our Walgreens location, we can use our care teams to be able to conduct an actual clinical trial visit at our location," she said.

Walgreens also plans to leverage CareCentrix, a home health management company the retail giant bought last fall, to deploy home health care solutions to enable patients to participate in clinical trials from home, she said.

Walgreens operates about 9,000 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. More than 75% of Americans live within five miles of a Walgreens, according to the company. The company's broad reach into communities will help make clinical trials more accessible, particularly to patients with complex or chronic conditions, executives said.

During the COVID-19 pandemic, Walgreens administered more than 63 million vaccines and provided 43 million COVID vaccine shots in socially vulnerable areas around the country, according to Tandon.

"A lot of the effort that it took to get into these communities, it was grassroots efforts; whether it's vaccination buses or care teams, we spent the time to educate and empower these communities to really understand the benefits of vaccinations," she said. "Those same frameworks and principles will apply to clinical trials. We will take on a number of modalities across the Walgreens organization that allows us to leverage our experience, leverage our personal relationships with our communities and start to educate and empower our patients to understand the value and the benefits of participating in research."

She added, "I personally believe that if you do that and spend the time to educate communities and get them to understand the value, you'll start to improve the participation rate."

With the combination of pharmacy and primary care locations and telehealth services, Walgreens also can offer a hybrid model, which coincides with the rapid rise of virtual or decentralized clinical trials. Decentralized clinical trials became commonplace during the pandemic as companies scrambled to maintain research when in-person contact was precarious and, at times, dangerous. 

But the decentralized clinical trial landscape is here to stay, Fierce Biotech reports, as about 77% of senior clinical research executives said they plan to run a hybrid trial in the next 12 months compared to 59% for the previous year. That's slightly higher than the 7 in 10 who said they plan to run traditional, site-based studies in the next 12 months.

Walgreens works with a startup called Pluto Health, a health data platform that aggregates medical records as well as lab and pharmacy data. The startup says it provides access to about 90% of healthcare institutions across the U.S., amounting to about 280 million patient records.

Walgreens plans to leverage that partnership to help drug manufacturers match patients to clinical trials, Tandon said.

"Our partnership with Pluto allows us to understand both the clinical as well as the pharmacy insights of a patient journey to identify the patient with more precision. So rather than cast a wide net across the U.S. population to see if there's interest in participating, we will take a much more targeted and precise approach in our targeting methodology to find the right patients in the right communities for the trials," she said.