The never-ending challenge of finding and recruiting eligible clinical trial participants continues to push sponsors to find new avenues to expedite enrolment. As decentralisation shakes up traditional trial planning and execution models, formerly adjacent healthcare ecosystem players, such as pharmacies, see the clinical trial space as an opportunity, and are seen by sponsors and CROs as a potential new approach to patient identification and engagement.
Historically, the clinical research space viewed the pharmacy as a channel to educate and raise awareness within the local community. However, over time, pharmacies started to build meaningful and rich information databases about patients and their medical needs.
“The pharmacy increasingly became viewed as a place where, if we could tap that data source, it would allow us to better target individual patients or patient communities,” says Kenneth Getz, director and research professor at Tufts University School of Medicine and founder of Center for Information & Study on Clinical Research Participation (CISCRP).
While this model is being explored more in some countries than others, it holds several benefits in clinical trial conduct, such as reaching underrepresented communities and giving access to better healthcare. Yet, as with every new approach, there are areas of potential pitfalls or challenges that might hinder clinical trials.
Retail pharmacy giants leverage their footprint
Pharmacy-based recruitment entered the clinical trial industry in the US first, with behemoth chain pharmacies such as CVS and Walgreens entering the clinical trial space. CVS’s clinical trial journey started during the Covid-19 pandemic when it was difficult to enable clinical research in traditional sites, says Josh Rose, vice president and head of clinical trial delivery, site solutions and strategy at CVS. “Because of our pharmacy footprint, many pharma sponsors and the government looked at CVS to enable the delivery of clinical trials, particularly for vaccines and Covid-19 testing,” he adds.
The large footprint of these chain pharmacies is what makes them a convenient place to find suitable patients. “CVS and Walgreens are everywhere, and it is very important as one of the challenges with clinical research and why there is a low patient participation is because sites aren’t everywhere,” Rose says.
Because retail giants are everywhere, questions have been raised about competition. Rose explains that he does not see Walgreens as a competitor because there is a real scarcity of good clinical trial sites and retail clinical trials can fill in that void. However, he notes that CVS has the advantage of having a large insurance arm, which gives access to millions of patients. CVS offers four capabilities: data-driven patient recruitment, trial delivery at 100 locations that follow all the same processes and training as traditional sites, home research services that deploy certified research nurses to patient’s homes, and real-world evidence capabilities.
In an email response, Ramita Tandon, Walgreens’s chief clinical trials officer, says that active community engagement and education can improve access for patients who traditionally have been left out of clinical trials. With their entry into the clinical trial space, the company is aiming to boost patient enrolment, engagement, and retention.
Walgreens is investing in technology and data solutions to offer clinical trials as a care option to their patients, even after the trial has ended. “Our goal is to take trial participants, even after they’ve finished their obligations to a clinical trial and continue their care coordination as part of our commitment for last-mile enablement and closing care gaps,” she says. In addition to the large physical footprint, Walgreens is also going to be decentralised. The retail giant is planning to launch a decentralised clinical trial platform with the support of Principal Investigators and clinical research staff to facilitate clinical trials of all configurations, Tandon notes.
CVS and Walgreens are not the only retail giants entering the clinical trial space. In October 2022, Walmart announced the launch of Walmart Healthcare Research Institute (WHRI) to increase community access to research. The latest new joiner is Kroger, which announced its clinical trial site network earlier this year.
Chain versus independent pharmacies
While everyone is talking about big retail pharmacies, Gerald Finken, CEO at RxE2, a digital health company focused on community-based clinical trials, says that it will be the independent community pharmacies that will make a difference in this new model.
Even though big chains have a large footprint and access to a lot of data, they are only connected to the community by over-the-counter sales, while independent pharmacies have built a trusting and long-lasting relationships within their community, Finken explains
Getz agrees that the relationship between the health or research professional and the patient is a sacred one, but it does not mean that big pharmacy chains are incapable of creating quality relationships. “Many of these big pharmacy chains have absorbed local pharmacies that have been rebranded, but they still have a tremendous interactive level of interaction and integration within the community,” he says, adding that independent pharmacies might lack infrastructure, data, and patient volume.
Outside the US
With retail chains in the US leading the way for pharmacies to be a part of clinical trials, similar players and sponsors in other countries are yet to fully tap in. In Canada, a number of large chains are keen to partner with pharmacies, says Dr David Campbell, assistant professor and consultant endocrinologist at the University of Calgary, Canada. “They see it as an area to potentially provide some social impact and the types of trials that I do are focused on health disparities,” he adds.
Australian sponsors are also looking at the potential of pharmacists in clinical trials, says Dr Christina Abdel Shaheed, pharmacist and senior research fellow at the School of Public Health at the University of Sydney. She notes that it would not be a battle between chain and private pharmacies, but more about the willingness and interest of the pharmacists themselves to participate in a clinical trial.
Sponsors in the UK, on the other hand, are yet to explore this model, says Olivier Picard, director of Newdays Pharmacy in the UK. He explains that the clinical trial market had been earmarked for CROs, and introducing pharmacies would be a big change for the industry.
While this model is certainly feasible to be introduced to the UK market, Picard says that it will be led by independent community pharmacists. While there are chains like Boots and LloydsPharmacy, they have announced redundancies and staff shortages in recent years. “They might have a bigger footprint or have a shinier spreadsheet, but when it comes to delivering, they will not deliver it,” Picard notes.
Logistical challenges and applicability
Even though pharmacies hold a lot of promise, there are several potential challenges or pitfalls that might hinder the execution of a clinical trial. First, a pharmacy might lack some elements of privacy and certain patients might not be comfortable waiting in an open area, says Getz. Picard explains that there needs to be a separate area within the pharmacy that could be dedicated to assessments for a clinical trial.
Another challenge for pharmacy clinical trials is applicability. Certain disease areas, such as oncology, will not be good for the pharmacy model, especially if invasive interventions are part of the protocol, Rose notes. However, disease areas such as dermatology, respiratory, cardiovascular, neurology, pain, or infectious diseases can lend themselves better to this model, he adds.
Pharmacists might also need additional training. Finken explains that pharmacists already perform the majority of tasks that they might be asked to do for pharmacy clinical trials. “Recruiting patients into a clinical trial is no different than recruiting them to a new diabetes education,” he adds. Nonetheless, more clinical trial-specific training around protocols would still be needed.
What do pharmacists say?
While it is important to talk about pharmacies from the business perspective, it is also crucial to understand what pharmacists themselves have to say about being a part of a clinical trial. Campbell’s qualitative analysis showed that pharmacists were keen to help recruit a clinical trial because it had a clear benefit to their patients by providing free medication or eliminating copayment. Also, the same study showed that recruiting via pharmacists is one of the most cost-effective methods, compared to other methods such as social media.
Participation in clinical trials might be an additional revenue stream, especially for independent pharmacies, Finken says. “Pharmacies will adapt to whatever they need to do in order to remain in business so they can continue serving the population that they serve,” Picard explains.
However, it is crucial to embed clinical trial processes into the workflow of pharmacists, says Abdel Shaheed. “Although they very much would love to be involved in research and pharmacists have a significant role to play in this area, there are practical and pragmatic considerations that must be considered,” she explains. For example, if it is a busy pharmacy and there is only one person on duty that day, a clinical trial will become a lesser priority, she adds.
While the potential is there, pharmacies have only started to play a modest role in the clinical trial industry and there is still a long way to go to see what impact they will have, Getz says. While it might be a modest role, it has an impact on reaching underrepresented communities and improving diversity in clinical trials.
- Retail pharmacy giants like Walgreens, CVS, and others are entering the clinical trial space one after another. Sponsors in other countries are yet to fully explore pharmacy-based recruitment.
- Chain retail pharmacies can offer large footprints and datasets, whereas independent pharmacies tend to offer trusting relationships within the community.
- Even though pharmacists are willing to participate, the trial processes need to be embedded seamlessly into their workflow without causing additional burdens.