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01/13/2023

How retail pharmacy is entering clinical trial services

Retail pharmacy’s foray into clinical trial services is a no-brainer given their enhanced focus on improving patient outcomes in the communities they serve.

It is no secret that retailer behemoths are gaining momentum in diversifying into primary care. 

What’s lesser known is that they also are carving a niche in an unanticipated area: the clinical trial services business.

Retail pharmacy’s foray into clinical trial services may raise some eyebrows, but it is a no-brainer given their enhanced focus on improving patient outcomes in the communities they serve. Additionally, there is an increased need by pharmaceutical companies to develop and bring new drugs and vaccines to market amid increased regulatory efforts by the Food and Drug Administration to promote clinical trial invitation and participation among diverse adults. It’s clear that branching out into this space is a win-win-win for retailers, patients and pharma companies.

Still, forging ahead in the clinical trials space can be a daunting endeavor given the lack of awareness among prospective participants. In fact, in 2020, 41% of Americans reported not knowing anything about clinical trials, according to The National Cancer Institute’s Health Information National Trends Survey.

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This substantial lack of awareness comes as the number of clinical trials is soaring. According to the National Institutes of Health, the number of registered clinical trials grew by 37,000 from 2021 to 2022.

Michael Abrams, managing partner of consulting firm Numerof & Associates, said the pandemic highlighted that minority groups have more health problems and less access to healthcare delivery, yet clinical trials typically do not reflect the minorities that make up the broader U.S. population. “Roughly 80% of the populations that are involved in clinical trials are white participants and minorities, blacks, Hispanics, Asians and native Americans are underrepresented,” Abrams said.

Catherine Gregor, chief clinical trials officer for Florence Healthcare, echoed Abrams’ sentiments, and advised the industry to make sure it’s reaching patients representative of real-world populations. “This will mean relying on different types of sites and moving research further into communities where patients live,” Gregor said.

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Prime standouts that have the capability to move research into communities and are making headway in the clinical trial space include CVS Health, Walgreens and Walmart.

In June, Walgreens, which had some experience recruiting participants for trials, launched a tech-enabled clinical trial business.

“Early on we dipped our toes into clinical trials when manufacturers reached out to simply send out letters to our patient communities to elicit interest,” said Ramita Tandon, chief clinical trials officer of

 

 

 

The number of registered clinical trials grew by 37,000 from 2021 to 2022. SOURCE: NATIONAL INSTITUTES OF HEALTH
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Walgreens. “It was an opportunity for manufacturers to tap into our ecosystem. This year we launched more of a tech-enabled solution that allows us to invest in the area of real-world evidence and become more precise in how we find patients and make sure we are bringing the right trials to the right patients in our Communities.”

Another player, CVS Health, is cementing itself in the clinical trials industry. For a decade the retailer has operated a home research organization that has supported more than 200 clinical trials, particularly in oncology, in patients’ homes. It also operates a group that has completed 100-plus real-world evidence studies for pharma companies.

Eyeing a more expansive vision of the role it could play within clinical research, CVS Health created Clinical Trial Services, aka CTS, in May 2021.

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“CVS Health redefined the problems it wanted to solve within clinical research, including a focus on the patient and health equity, and industry and regulators’ excitement and interest in community models to help them achieve those goals,” said Tony Clapsis, head of CVS Health Clinical Trial Services.

The depth of CTS’ ability to support pharma and patients is evidenced by its ability to help patients access therapies in phase 2 and 3, do follow up and safety work, and produce a compelling set of evidence around how well the products work in phase 4.

Walmart, while a newcomer in the clinical trials business space, is making inroads since launching Healthcare Research Institute in October 2022. Emphasizing that for therapies to be successful, they need to be evaluated in everyone who may take them, John Wigneswaran, chief medical officer of Walmart said, “We saw during the pandemic the importance of having equitable healthcare research to inform safe and effective therapies for all in the setting of COVID-19. Walmart Healthcare Research Institute will be focused on innovative interventions and medications that can make a difference in underrepresented communities, including older adults, rural residents, women, minority populations and more.”

Since beginning outreach earlier in 2022, Walmart has engaged with thousands of patients and seen a referral rate at three times the industry benchmark. But while those numbers are impressive, Wigneswaran said the company is measuring success based on its ability to make an impact on health equity and bring solutions to customers who have previously been overlooked.

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The ability to offer convenient options for patients to participate in clinical trials is a hallmark of successful retailers in this space. One only has to look at Walgreens.

Noting the COVID-19 pandemic put a spotlight on the need for the clinical trials industry to come together and find different ways to engage patients, Tandon said that because of the shut down patients were unable to get to clinical trial centers and manufacturers were looking at novel ways to reach consumers in trials moving forward.

“That momentum has carried forward and the industry is now looking at ways to leverage Walgreens using our footprint as an opportunity to bring trials into our communities,” Tandon said. “We are creating opportunities to afford better convenience for patients to participate and start to remove some of the barriers that traditionally exist for patients for clinical trials.”

One of the biggest barriers to patient participation has been a structural one, especially for patients in the deep South and in rural areas. When patients sign up for trials and have to travel far distances to academic medical centers, they often don’t participate in follow-up visits.

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“The dropout rate is more than 20% and that becomes a big loss leader for clinical trials,” Tandon said.

To overcome that barrier, Walgreens has a flexible set of options. It has activated 10 clinical trial centers at its Health Corner locations in California, New Jersey and Ohio. It also offers the option to participate via phone calls and through its recent acquisition of CareCentrix, Walgreens can conduct certain aspects of clinical trials in a patient’s home.

CTS also is heavily focused on convenience and is offering trial participation virtually and in people’s homes. Noting that patients have had to travel about two hours to get to a site, which are often located in urban areas, Clapsis said the inconvenience leads to some of the challenges in retention.

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“One in five patients drops out of clinical trials because of the burden associated with participating in the clinical trial itself,” Clapsis said. “CVS is helping recruit patients across geographies, across states and deep into communities. We have a 20-year history of having over 1,100 MinuteClinics, and a deep foundation in protocolized work led by our nurse practitioners, which enables us to bring research into that environment and have the confidence you’re going to do it in a way that meets patients’ and sponsors’ expectations.”

CTS has brought research opportunities to 25 million members, and it has enrolled roughly 20,000 patients across 15 therapeutic areas.

Walmart is not standing on the sidelines when it comes to convenience. The retailer has created MyHealthJourney, a digital tool that makes it easier for people to join clinical studies while also simplifying their care and closing care gaps. With MyHealthJourney patients receive reminders for care services and research opportunities to help them keep their health on track.

“This digital tool allows research patients to access their own health information, including eligible medical records and insurance information, as well as gain insights on how their health measures up to the latest evidence-based guidelines,” Wigneswaran said.

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Additionally, Walmart is working with a wide range of study partners that will be facilitating research, including clinical research organizations, pharmaceutical companies and leading academic medical centers including CTI Clinical Trial & Consulting Services and Laina Enterprises. “As we progress, we’ll look to see how our pharmacies may be able to serve as a location where patients can receive study medicines and function as a study site, making healthcare research more accessible to our customers,” Wigneswaran said.

Attracting and retaining diverse participants is a crucial responsibility for retailers in the clinical trials space.

CTS is a prime example. “We’re operating in 12 states,” Clapsis said. “Beyond patient demographics, we looked at social determinants of health, key criteria to ensure we are opening locations in areas that traditionally did not have access or as much access to help them broadly do clinical research.”

Walgreens also places a priority on ensuring diversity in trials. The retailer has made significant investments to create a “real-world evidence engine,” which brings together the patient’s pharmacy records and access to the patient’s clinical records.

“We’ve created this infrastructure in a very highly compliant regulatory fashion along with protecting patient privacy,” Tandon said. “The insights we’re able to glean allow us to index where those patients are located, and when we speak to the drug manufacturer, we’re very intentional about making sure that we are including patients from geographic regions or communities that have never been tapped into. Less than 5% of the U.S. population participates in clinical research, and of that 75% are white, so we are making sure from a patient population perspective that we’re

In 2020, of Americans reported not knowing anything about clinical trials. SOURCE: THE NATIONAL CANCER INSTITUTE’S HEALTH INFORMATION NATIONAL TRENDS SURVEY
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tapping into communities and introducing those communities to manufacturers as potential trial candidates for these trials.”

Addressing equity also is a top priority for Walmart. Pointing out that for decades, clinical trials have not been representative of the population at large and often recruit patients who live near research centers, have the time and are financially able to participate, Wigneswaran said, “Many groups have been underrepresented in research, including older adults, rural residents, minority populations and individuals of low socioeconomic status. By increasing access to healthcare research, that research can become more accurate and specific to different patient populations, improving the overall quality of care for all.”

Noting that 90% of Americans live within 10 miles of a Walmart, which has 3,991 locations in medically underserved areas, Wigneswaran said, “Walmart is in a unique position to reach traditionally underrepresented people and offer access to healthcare research where they shop for everyday essentials.”

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Beyond increasing the diversity of participants, building awareness and trust are paramount to success in this space.

Education and trust are two things that Walgreens is passionate about. “Walgreens is making sure that it is educating the communities as part of our community surround sound. When a patient receives an outreach from Walgreens around a particular clinical trial, we want to make sure that that patient has been appropriately informed and educated about what a clinical trial is so it makes sense and they feel empowered to make the right decision,” Tandon said. “It’s about the ‘triple E’ framework of engaging, empowering and enabling patients in their community to understand clinical trials and make the right decision for themselves.”

Providing education and building trust also are top of mind for CVS. Pointing out that only about 5% of Americans have ever participated in clinical research opportunities, Clapsis said, “There’s a general lack of awareness and access to research. It’s about your relationship, and trust. The two are closely connected. We felt confident that this is something our patients were going to welcome and view as an extension of the relationship that we have with them. You see that trust with CVS pharmacists and clinicians in the relationships that we have.”

 

 

The dropout rate is more than 20% and that becomes a big loss leader for clinical trials. — RAMITA TANDON, CHIEF CLINICAL TRIALS OFFICER, WALGREENS
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walgreens-patient-and-clinician

CTS also works with health systems and primary care specialist groups. “We’re able not to just go directly to the member, but also reinforce trust in the relationships by working with partners in these communities to ultimately galvanize ourselves around the needs of the patient,” Clapsis said.

As retailers provide clinical trial services, they also are finding that collaborations with partners are crucial.

Take the case of Walgreens. “We recognize that we cannot do this alone. We’re being very intentional and purposeful as we create an ecosystem of partners to help support and move the needle in some of these big areas around diversity, equity and inclusion,” Tandon said. “We’re being very thoughtful as we bring on partners, particularly as we’re looking to mobilize efforts and start to educate and empower our patients in our communities.”

Walgreens partners are not only pharma manufacturers; they are healthcare systems and technology companies, too. “Healthcare systems want to leverage our physical footprints to bring patients in for follow up visits and ensure that patients are retained during the course and duration of clinical trials,” Tandon said. “We partner with technology companies to bring more solutions into the overall workflow.”

CTS is no stranger to working with partners in the clinical trials space. Pointing out that it’s important to understand from the disease state what are all of the criteria characteristics of the kinds of patients who may be eligible, Clapsis said, “How do you identify the right technology partners that can help you build the patient experience you want while managing your data in the way that’s most effective for the trial itself? With Medable and other partners we’ve been focused on building the technology solution we need for our nurses and clinicians to be able to deliver the services to members and operate at the top of their game.”

Utilizing a multi-disciplinary approach that includes pharmacists also is critical for success in the clinical trials business. Walgreens is a frontrunner in taking this approach.

“As we expand the role of the pharmacy infrastructure overall in health care, the same applies to the world of clinical trials,” Tandon said. “The physician has the role as the primary investigator in clinical trials, and the pharmacists along with our health advisors — including nurses — are all part of the care team and will engage the patients in the course of clinical trials. When patients do select the option to come into a local pharmacy to be able to learn more about the clinical trials, that’s when the pharmacists will be able to have an opportunity to have a dialogue with that potential patient and have them understand the benefits of participating in clinical trials.”

CTS also is using a multidisciplinary care team approach. “You need multiple components,” Clapsis said. “One is a principal investigator,a doctor, who oversees the study. In MinuteClinics often the nurse practitioner is conducting the specific visit, and is supported by a clinical research coordinator, who is supported by a pharmacist and a research pharmacist who handle the investigational product.”

What disease states are ripe for clinical trials in the future? Walgreens’ priorities are to look at disease conditions that impact the swath of the nation, and which have healthy equity issues, such as cardiovascular outcomes, diabetes and chronic kidney diseases.

“We are planning to continue to expand and help support drug developers as they are conducting trials, particularly as they are looking to respond to diversifying their clinical trials,” Tandon said. “We are very focused on growing in a number of critical disease areas.”

CTS, which is supporting trials in 15 therapeutic areas, including vaccines, metabolic and dermatology, plans to expand into additional therapeutic areas as well as the states where it conducts trials. “Let’s have a network that can deliver patients the choice and experience they want and deliver for sponsors who are running these studies the ability to start studies sooner, obtain patients better and hit all of the other end points they are looking to do,” Clapsis said.

Walmart Healthcare Research Institute, which is initially focused on diabetes, cardiovascular disease, COVID-19 and asthma, is looking at HIV, dementia, obesity and rare disease as future opportunities and will focus on innovative interventions and medications that can make a difference in underrepresented Communities.

Perhaps Wigneswaran summed up the future for all retailers in the clinical trials research space best with these words: “Our goal is to make an immediate impact for our customers and the medical research community. We’re in a unique position to reach traditionally underrepresented people and offer access to healthcare research where they shop for everyday essentials.”

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