From The Editor | September 12, 2022

Walgreens Is Ready To Re-Envision Recruitment, DCTs, And RWE

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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Since becoming CEO of Walgreens Boots Alliance (WBA) in March 2021, Rosalind Brewer has been focused on healthcare and what the company could do to help its patients. WBA refers to the integrated healthcare, pharmacy, and retail store that currently serves millions of customers and patients every day. For that reason, Walgreens plays a critical role in the healthcare ecosystem.

When Brewer was hired, WBA was playing a key role in distributing and administering COVID-19 vaccines. The big question for Brewer and the company at that time was how it could better leverage its expansive footprint, partnerships, and the trust it had with customers and patients to provide additional benefits and services within the healthcare ecosystem. In October 2021, Walgreens announced that it had a new business segment called Walgreens Health to deliver interconnected experiences that combine in-store, at home and virtual access to health solutions that add up to better health outcomes and lower costs. This past June, as an extension of the broader Walgreens healthcare vision to deliver consumer-centric healthcare solutions, the company launched its clinical trial business. 

A Focus On Healthcare

Adam Samson, head of clinical delivery operations and RWE clinical trials, Walgreens
Walgreens currently has 160 million consumers and patients using its products and services in one of 9,000 stores located across the U.S. According to Adam Samson, head of clinical delivery operations and RWE clinical trials, 78% of the U.S. population is within five miles of a Walgreens location. Approximately half of those stores are in socially vulnerable areas.

“Those are just a few of the statistics that drove the company’s decision-making,” states Samson. “When Brewer joined the company, she recognized there was an opportunity here to truly help the healthcare industry. That industry has been rather fragmented. Walgreens saw the opportunity to help create a more interoperable healthcare system.”

The goal of Walgreens is to become part of a care continuum. The company has no plans to disconnect patients from their healthcare providers or PCPs. Still, the company’s assets provide it with the capability to quickly roll out a nationally scaled, locally delivered healthcare platform.

John Campbell, head of decentralized trials, Walgreens
“During the pandemic, we administered more than 67 million COVID vaccines,” says Samson. “No one was prepared to do the things that we suddenly needed to do during the pandemic. But Walgreens was able to quickly develop the capability to administer these immunizations in our stores using the capabilities of our pharmacists and other staff. Those capabilities are now the foundation of our clinical trials business and is another way Walgreens Health can offer additional care options for our patients.”

Bring In Needed Expertise

Once the decision was made to offer clinical trial services, Walgreens needed knowledgeable individuals to head up the effort. The company hired industry veteran Ramita Tandon as its chief clinical trials officer in November 2021. Tandon has more than 25 years of experience in the clinical trial space with time at CROs and health tech startups. Tandon’s focus has been on building a transformative and innovative tech-enabled clinical trials business model for Walgreens with a strong regulatory compliance foundation. She brought Samson and John Campbell, head of decentralized trials, on board for their clinical expertise. She has made additional key leadership hires, and the clinical trials team is now working to operationalize the business. Additionally, Walgreens recently became a member of the Avoca Quality Consortium (AQC), a community dedicated to improving clinical trials via the development of standardized performance metrics and knowledge sharing that drives cross-industry collaboration, as a testament to the company’s focus around quality and compliance.

Ramita Tandon, chief clinical trials officer, Walgreens
Other changes made to the Walgreens business model over the last few years will help accelerate the company’s ability to successfully operate in the clinical trial space. VillageMD is a primary care company in which Walgreens has a majority ownership position. Many of VillageMD’s primary care practices are co-located with Walgreens pharmacies in neighborhoods throughout the U.S.

Another growing initiative is Walgreens Health Corners, which is the company’s effort to help health plan subscribers improve health outcomes. Health Corners will have dedicated space in the stores, as well as an app, to help patients stay on track even when they are between doctor visits. The Health Corners will offer access to health advisors including pharmacists and registered nurses who will work collaboratively with health plans. For example, in June 2022, Walgreens partnered with Buckeye Health Plan, an Ohio insurer, to bring health and wellness services to five locations in northeast Ohio. Walgreens currently has around 60 Health Corners, and a recent article in Forbes notes the company hopes to have 100 of them open by the end of 2022.

“Over the past year we have been building out a footprint at a number of stores in socially vulnerable regions,” notes Samson. “With VillageMD and our Health Corners, we are in a good position to plug clinical trial services into that existing infrastructure. These locations are well suited for clinical trials.”

Build A Clinical Trial Organization

As soon as Tandon joined the company she began having conversations with industry connections about the help they needed and what Walgreens could do to meet their needs.

The current goal of the clinical trail business is to take the lessons learned from the pandemic, when companies were scrambling to keep their trials afloat, and apply those learnings to a new generation of clinical trial delivery models, such as decentralized trials, to make them more accessible, convenient, and equitable

“The new technologies that sponsors have adopted over the last two years will hopefully de-risk trials and improve trial delivery by incorporating decentralized tools and techniques,” says Campbell. “The goal is to incorporate these innovative technologies from the very beginning. As sponsors have used these tools, they have begun looking at non-traditional trial sites, including retailers like Walgreens, and questioned how those locations could offer home-based assessments and home-based care. The hope is to conduct clinical trials in a way that reduces burden for patients, removes risk from trials, and improves data quality. We can also improve operational efficiency along the way.”

As drug developers looked at trials through that lens, they became very eager to engage with Walgreens to understand how the company could work within that framework to deliver trials with a broad range of needs.  

A Decentralized Approach

Patient recruitment will be a primary service provided by the Walgreens clinical team. Samson notes 80% of trials fail to meet their enrollment timelines, which makes faster enrollment of patients a priority for drug developers. Nine million of the 160 million customers Walgreens has access to will visit a store location every day. That provides the company with the ability to reach millions of patients in ways that traditional sites cannot.

With 9,000 stores, Walgreens also has access to patients in ethnically diverse neighborhoods across the country. Reaching patients where they are, and enrolling more representative populations, is another way Walgreens believes it can help sponsor companies with their recruitment challenges.  

Walgreens also can deliver trials to patients in ways that reduce the burden of study participation. This DCT, or hybrid approach, will enable more patients to participate in studies and could improve retention numbers. Still, for many sites, there are challenges that need to be overcome.

“There seems to be an industry consensus that decentralized trials will lead to streamlined operations across trials,” says Campbell. “But what we have seen thus far is the DCT model being tacked onto traditional site models. That has created a mix of different systems being used for different purposes, as well as studies with overlapping systems being used for the collection of data. I have seen studies with 20 vendors doing essentially the same thing on the same trial. That is a significant concern, and I believe Walgreens can roll out a unified solution across our site network.”

Campbell notes Walgreens will use a decentralized platform and eSource to enable both home and in-clinic visits. All patient data is collected through the same unified platform via a study that has been designed as a hybrid trial from the start. This model will enable the company to work on any protocol that is aligned with the needs of patients. The standardization, centralized team, central IRB, single budget, and single electronic system are expected to create trial efficiencies, lower costs, and time savings.  

Change Patient Perceptions

Walgreens also hopes to take a flexible approach to trials. For example, the company is not against partnering with a large academic institution for a certain study if the right opportunity arises. The goal is to take trials to patients, wherever they happen to be. 

The third way Walgreens can help drug developers is with real-world evidence (RWE) studies. This will involve combing through clinical treatment records and pharmacy records to drive decision making for Walgreens use cases and finding ways to leverage data and work with patients over time.  Walgreens RWE engine will feed into how the company identifies patients, hyper-personalizes patient engagement in local communities and further supports patients’ treatment journeys as they participate in the trials the company supports. It will also provide researchers with greater insights into their condition and their disease progression.

The approach that will be used by Walgreens is likely to change the way sponsors view trials, recruitment, and the gathering of RWE. Samson also hopes the company’s approach will change consumer attitudes towards trials and distrust that may exist toward pharma companies and the healthcare industry. With the qualitative and quantitative insights Walgreens will have on patients, Tandon and team aim to hopefully reduce the barriers for participation and change patient perceptions.

“Before even talking about recruitment for a specific study, we need to get into these communities to work on the lack of trust and understanding,” says Samson. “That is something we are perfectly poised to do. Walgreens is already in these communities, and we already have a relationship with these customers. When the right opportunity presents itself, we can help them understand a trial and how it might help them. I like to tell people that the clinical trial model does not need to be disrupted. Sites and site networks can continue to do what they are doing. But if 80% of trials fail to meet enrollment timelines, there is room for players like Walgreens to enter the space and help improve that number.

“One of our hopes is that the work we do can improve how other sites operate in the future by paving the way with new technologies and workflows,” adds Campbell. “There are areas where I think we can provide good care to patients, such as vaccines and chronic disease management. And we have a unique ability to engage with patients. Many people assume that patients are recruited into trials by their doctor. That is a persistent misunderstanding. In 2020, the number of patients who were recruited into trials by a physician was around 10%. Approximately half of patients in a trial were recruited via advertisements. One of our goals is to find better ways of engaging with patients to help them make informed decisions about whether they want to participate in a study.”