Ruby Madison Ford

Image Credit: © ipopba - stock.adobe.com

Retail pharmacies have slowly established their positioning within the clinical research enterprise, proposing that the ubiquity of their locations and membership can fill existing gaps in participant diversity and clinical trial efficiency. While there has been interest in the industry around these ideas, the proposition is new and untested, with little publicly available data on what these clinical trials models will look like in practice or the ways in which pharmacy chain involvement can benefit or hinder the clinical research process. CVS’ unexpected and ambiguously explained exit from the clinical research enterprise in May 2023 elevates uncertainty around the viability of success for other retail pharmacies.

To begin to address this uncertainty and inform understanding about the potential role of pharmacy chains in supporting clinical trial planning and execution, in summer 2023, the Tufts Center for the Study of Drug Development (Tufts CSDD) conducted 10 45-minute interviews among clinical development executives of medium to large biotechnology and pharmaceutical companies to investigate industry awareness, attitudes, and concerns around retail pharmacy chain participation in clinical trials. Interviewees included vice presidents, directors, and managers in clinical operations, innovation, and patient engagement functions. The aim of the study was to assess reactions to CVS' departure and gather insights into how the market perceives proposed models, as well as identify the challenges that other pharmacy chains may need to address.

The interviews focused on both the benefits of pharmacy chain involvement as well as concerns and barriers to adoption. Primary benefits to retail pharmacy involvement were identified as:

Easier access to the public to increase awareness of clinical trials

Large databases of patients for recruitment

Identify sites in areas that have a large enough sample of eligible patients to open study sites

Staffing expertise (or lack thereof) and shortages

The recruitment funnel, described as the drop off of potential clinical trial volunteers when applying eligibility criteria

The large investment needed from pharmacies to develop trial infrastructure

The interviewees—clinical research executives—were excited about the potential of increasing awareness among the public about clinical trials. This was seen as the “lowest hanging fruit” because it would involve the least investment and minimal regulatory oversight. According to interviewees, materials have already been created by various sponsors to increase awareness, and retail pharmacies would merely be involved in the distribution of them. This would be simple to operationalize and could have a far-reaching impact.

Clinical research executives highlighted long-term follow-up (LTFU) as a major opportunity for retail pharmacies to provide their services. Typically, once LTFU is reached, no major procedures are being conducted; in most cases the treatment is no longer being administered; and most data collection has already been completed. Much of LTFU in current clinical trials is already done remotely or with the incorporation of select decentralized trial (DCT) elements, making this stage ideal for retail pharmacies to enter the market. This would also factor in the convenience of the patient, removing the need to travel to the research center after the trial has ended.

Site initiation duration for Phase II and III studies has been increasing, lasting nearly eight months. As such, improving site initiation is a priority improvement area cited by research executives. Additionally, a high percentage of sites fail to enroll or under-enroll patients representing a significant and ineffective investment of personnel time and financial resources during initiation.

 Interviewees noted the potential for retail pharmacies to help improve the site initiation process. More specifically, the offering included the ability to identify which areas have a large enough sample of patients fitting the target population and applying that insight to select investigative sites.

Throughout the interviews, there were 51 mentions of concern over staffing at retail pharmacies. While some concerns over staff expertise were specific to screening for eligibility, most were focused on retail pharmacy models in which patients would be receiving care in-person at the pharmacy or via telehealth or DCT models. These concerns spanned from the expertise, or perceived lack of expertise, of the staff that may work at a retail pharmacy, to staffing shortages that are currently plaguing sites.

“Nursing staff is actually hard to come by these days. And trained nursing staff from a research perspective…there's a limit there.” – Interview #5; Innovation, Large Pharmaceutical Company

It is well-known that staffing shortages exist across the healthcare system, particularly since the COVID-19 pandemic caused an exodus of workers from the industry. But sites have felt the pressure of a shrinking workforce as only a small proportion of healthcare providers contribute to research. Retail pharmacies entering the space and offering services will likely face the same barriers. This may even be a more significant barrier for retail pharmacies that note their positioning among more remote and rural communities—areas that may experience disproportionately high workforce shortages.

 Specifically, pharmacies have proposed that if patients in rural areas can have some or all site visits at a retail pharmacy location, they can increase patient access.

 However, interviewees noted that remote areas are less likely to have a large pool of potential candidates, narrowing options for clinical trial staff. Retail pharmacies have suggested various telehealth and digital models to circumvent this barrier, but interviewees expressed concerns over a primarily remote oversight model in clinical trial execution.

Due to shortages of staff, sponsor personnel were concerned that retail pharmacies may attempt to train research-naïve healthcare providers, or hire individuals directly out of a training program, instead of hiring seasoned clinical trial professionals. The perception was that these junior staff members would not have any supervision or guidance from more experienced professionals. This was of particular concern due to most oversight and monitoring positions being remote. Coupled with a junior workforce, these remote oversight positions were seen as insufficient to ensure compliance with regulatory requirements. Interviewees also questioned whether principal investigators (PIs) would be comfortable with remotely overseeing a large number of sites, as any regulatory issues or mistakes would be the PI’s responsibility.

The administration of lab work and collection of vital signs by the retail pharmacy has been suggested as a strategy to offer patients the option of going to the retail pharmacy instead of the site for routine monitoring, but any activities conducted at the pharmacy would still be overseen by a traditional site.

 Most interviewees supported this option because it only involved basic procedures that are typically present in clinical practice and can be executed by most healthcare providers. However, for more advanced or technical procedures that are specific to clinical trials, interviewees were concerned that pharmacy staff would not have the expertise to conduct trials effectively and safely.

In cases where clinical trial participants would go to the retail pharmacy for any type of service, interviewees questioned existing pharmacy infrastructure and whether these organizations are set up for clinical trial services. While recent entrants have begun adding medical clinics to their infrastructure, they are not as ubiquitous as traditional pharmacy locations.

 In order to fulfill the value of providing a convenient location for site visits, the organizations would need to expand specialty clinic locations, as interviewees did not see the typical retail pharmacy location as appropriate for clinical trial procedures. Specifically, sponsor personnel were concerned that these locations would not have the space to accommodate regulations such as a dedicated space for documentation and storage of drugs. However, the entrance of retail pharmacies in clinical trials is still novel, and interviewees acknowledged that this infrastructure could be built with significant time and investment.

“If they are going to set themselves up as a site, they are going to need the same kind of infrastructure that any other site has. And so, they'll have to make that investment, and that's another risk.” – Interview #9; Health Equity, Large Pharmaceutical Company

Finally, since pharmacies likely do not have the capability to test samples, any sample taken from a patient would need to be transported to a lab for testing. Contracting a pharmacy to collect blood samples, for example, to decrease the number of site visits, may add complexity to the trial because it adds additional operational considerations.

“The more complexity you add…there's just operational factors involved and potentially delay of data involved in receiving the sample, then actually getting the data back into the right hands to interpret.” – Interview #5; Innovation, Large Pharmaceutical Company

The primary value proposition of retail pharmacies is the large databases of patients with information that will help target potentially eligible research subjects. This has emerged as a frequently suggested clinical trial service offering from retail pharmacies with discussions revolving around its potential to enhance participant diversity and expedite the recruitment process.

A few interviewees suggested that pharmacy involvement in recruitment could be more beneficial if the retail pharmacy also contributed to screening. However, others questioned the training and ability of retail pharmacy staff to effectively screen patients. Interviewees who were hesitant about the idea suggested that retail pharmacy staff may misinterpret screening guidelines, or not have the patient data or resources to effectively screen patients. Apart from questioning the expertise of the pharmacy staff, interviewees suggested that sites may not be satisfied with retail pharmacy screening and would screen the patient again once they arrived at the site, which the sponsor would need to pay for—essentially being double charged for the same service. In this case, some type of prescreening was suggested so that the site will still have primary control over the screening process, but the patients being sent to the site have a higher probability of meeting eligibility criteria.

“From the site perspective, they have concerns about this because they want to make sure that they have the right information from a screening perspective. So, they want to be in charge of the screening. And of course, then the biopharma we don't want to pay for screening twice.” – Interview #5; Innovation, Large Pharmaceutical Company

“It's meant to give them [the site] 50 patients who have already been prescreened so that their chances of them getting onto a trial from an eligibility perspective is very high. And I do feel like they have a chance for that through some prescreening processes.” – Interview #9; Health Equity, Large Pharmaceutical Company

However, interviewees still had mixed feelings about the feasibility of this proposal and identified several barriers to fulfilling these promises.

Interviewees highlighted that retail pharmacies had not yet proven their ability to recruit patients at the speed, diversity, and quantity that they have promised. While some retail pharmacies participated in recruitment of patients for COVID vaccine studies, interviewees pointed out that the climate at the time was different, with many volunteers either wanting to help or wanting early access to the vaccines.

 Additionally, COVID vaccine trials studied healthy volunteers—a much larger pool of potential interviewees than most clinical trials. Therefore, interviewees were skeptical of the ability of pharmacy retailers to meet diversity promises in “real life” (i.e., non-COVID trials).

According to interviewees, there are many variables that impact recruitment of diverse populations, such as lack of trust of the healthcare and pharmaceutical industry, and having larger databases or being located in diverse areas is not a comprehensive solution.

 Retail pharmacies have stated that they are trusted actors of the community, and this will contribute to their ability to recruit patients.

 However, they have yet to prove that they are trusted enough by these communities to be able to convince patients to enroll in a trial or that they can compare to traditional community groups or leaders in their relationships with the community. Data on retail pharmacy ability to recruit patients in a variety of trial types and indications would be needed in order to convince sponsors of the value.

“I'm not necessarily convinced that, okay, if you went with this model, you would solve all of your diversity issues. I think it's a much bigger nut to crack.” – Interview #3; Clinical Development or Operations, Large Pharmaceutical Company

Others saw the value of retail pharmacies in increasing diversity, despite highlighting potential caveats.

"So, for me, I do believe that pharmacy chains could play a pivotal role, going forward, especially around increasing diversity of these patients in our trials.” – Interview #9; Health Equity, Large Pharmaceutical Company

There were similar mixed feelings among sponsor company executives when considering the proposal that retail pharmacies could make recruitment faster based on location and access to a larger database of patients. Some interviewees agreed that having a larger database could lead to faster recruitment. However, a number of interviewees brought up the “recruitment funnel,” described as an outcome of inviting a large number of patients to the study to undergo screening where only a small number will actually be eligible to participate.

Interviewees were concerned that if a large quantity of patients were sent to a traditional site for screening, understaffed sites would struggle to screen patients, and the investment of time and manpower to screen the patients would be wasted as many would be ineligible for the study. Some sponsor employees even suggested that sites would refuse to screen that many patients because they do not have the resources to do so.

“One of the drawbacks of going to these pharmacy chains which has access to many, many, many more patients than a site would is that the site will then get a deluge of patients who are potentially ineligible. And they are not going to like that.” – Interview #9; Health Equity, Large Pharmaceutical Company

Each retail pharmacy chain entering the market has stated their value proposition as being able to increase the diversity of clinical trials due to large databases of patients and strategic locations. Press releases and websites detail the current lack of diversity in clinical trials—an issue that the industry has long tried and failed to remedy—and propose that retail pharmacies can drive equity in clinical trials.

 While interviewees recognized the benefits of retail pharmacy participation, some pointed out that there is more to equitable access and participation in clinical trials than basic referral, including community and patient trust, travel support, and decreasing patient burden. Fulfilling this promise and gaining the trust of both patients and sponsors were seen as major challenges for retail pharmacy success.

Sponsors are also concerned about the current staffing and infrastructure of retail pharmacies and questioned whether these locations are set up to effectively conduct trials in compliance with good regulatory practices. However, most acknowledged that if pharmacies were willing to invest the time and funding to build an infrastructure that matched other sites, and data was available on the success and capabilities of retail pharmacies, the strategy could be successful.

Most importantly, clinical research sponsors want to see clear evidence—unbiased, empirical data—demonstrating the value proposition of retail pharmacy involvement in clinical research. In its absence, the value proposition remains largely theoretical and uncertain.

, MBA; all with the Tufts Center for the Study of Drug Development (CSDD), Boston, MA

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