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During the past three years, retail pharmacies have entered the clinical research enterprise in earnest, offering decentralized approaches supporting patient enrollment, clinical trial planning, and data management (Alsumidaie 2022). This entry was spurred, in part, by the COVID-19 pandemic, when retail pharmacies led vaccination efforts and some, such as CVS Health, contributed to nationwide recruitment into vaccine trials.

Despite industry-wide excitement over the involvement of retail pharmacies, there is little information currently available on how retail pharmacies are perceived by investigative sites and patients. The recent exit of CVS Health two years post-pandemic has raised further questions about the viability of, and patient and investigative site receptivity to, this new model (“CVS’ Departure” 2023).

Retail pharmacies have stated that their proximity to patients and access to large patient databases could improve diversity, equity, and inclusion in clinical trials (“Walgreens Launches” 2022; Olsen 2023; Miseta 2022). These statements suggest that patients from diverse backgrounds are both interested and open to the idea of enrolling and participating in clinical studies through retail pharmacy services. At this time, however, there is no publicly available evidence to support these statements other than anecdotal reports based on experiences during the pandemic (Alsumidaie 2022; “Walgreens Launches” 2022).

Perspectives from investigative site personnel have been largely absent from commentary on pharmacy involvement. In-depth interviews among site personnel will provide important insights on this essential community’s receptivity to retail pharmacy involvement in clinical research and will inform the viability of this promising new clinical trial support model.

To address these gaps in our understanding, throughout Summer 2023, the Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a qualitative study among US-based investigative sites and patients. This article summarizes the results of this qualitative study with the goal of offering insights into retail pharmacy viability and how pharmacies can best engage with investigative sites and patients. This paper is the second in a series published in Applied Clinical Trials—the first looked at sponsor perceptions and concerns around partnering with retail pharmacies.

The target population for site personnel included principal investigators (PIs), clinical research coordinators (CRCs), and administrative personnel who are experienced in conducting industry-funded clinical trials and currently employed by an investigative site located in the United States. Tufts CSDD targeted patients who are adults residing in the United States with a medical condition. Please see Botto et al., 2023 for more details on study methodology.

Ten patients and ten site personnel participated in 45-minute virtual interviews. Patient interviewees were evenly distributed between male and female and were primarily clinical trial-naïve, with three out of ten interviewees having participated in a clinical trial prior to the interview. Three patient interviewees identified as White, three Hispanic/Latino, two as Black or African American, one as Asian, and one identified as White and Hispanic/Latino.

Three out of ten investigative site personnel interviewees were PIs, two were CRCs, and five were administrative personnel. Site personnel interviewees primarily worked at academic medical centers (six out of ten), with four interviewees working at a site network, research institute, or community-based hospital. The following themes were identified in the interviews

Barriers and Concerns

Staff Competency

Trust in pharmacy retailers and their involvement in clinical trials were addressed among all stakeholder groups. Patient interviewees expressed concern around site staff credentials and training, perceiving the pharmacy’s role as limited to filling medication prescriptions and occasionally administering vaccines. Patients also felt that they had a low rapport with their pharmacist, leading to challenges in viewing their pharmacy as a reliable source of information beyond their prescribed medications.

One patient participant remarked, “I don’t know my pharmacist personally. I don’t think they know much about my health in general…For them to refer me to a study clinic for a trial is odd to me, because they don’t even know what my health history is and why I would be appropriate for one.”

Some patient interviewees were more open to the idea of participating in models in which they would receive trial procedures at a pharmacy, but only if their routine physician recommended the clinical trial or was overseeing the study. Site personnel expressed distrust in retail pharmacy site staff producing quality work.

One site interviewee stated, “At most institutions, you at least have a couple of senior people who can kind of show them the ropes a little bit. But when it’s something that’s in such a new area that trial by fire, it’s not going to be successful.”

Another questioned whether the pharmacy staff would have other responsibilities outside of the clinical trial and was concerned that staff would not have their full focus on the clinical trial when receiving time-sensitive samples. Investigative site interviewees also highlighted important differences between clinical care and clinical research, such as assessing for adverse events and consenting, as well as differences in dispensing medication such as blinding, randomization, and placebo creation. To conduct research activities outside the pharmacy staff’s scope of practice, interviewees emphasized the importance of specialized training and the presence of experienced clinical trialists overseeing the process.

The principal investigators (PI) in this qualitative study voiced concerns about losing a direct connection with their study participants. For pharmacy models in which the patient would receive procedures at a pharmacy, PIs expressed concern that they will not be able to personally oversee the care provided to their study participants and, as a result, it will be more difficult to monitor patient safety.

Data and Health Privacy

Site personnel interviewees voiced their concern about whether pharmacies would be prepared to handle the secure transfer of data between the pharmacy and the site. While patient interviewees were less concerned about data privacy, six out of ten expressed the need for a large private, designated area to participate in clinical research, including a safe space for immunocompromised participants. According to both stakeholder groups, adjusting the pharmacy infrastructure would also assist in maintaining data and health privacy as it would allow for more private conversations for data storage.

Regulatory Compliance and Accountability

Site personnel interviewees were concerned about regulatory compliance at the pharmacy, particularly accountability and liability for safety issues and noncompliance. Interviewees also questioned whether the pharmacy staff will be effectively trained in GCP and ICH, particularly when a team may lack any direct experience conducting clinical trials. Without assurance that regulations were being followed, interviewees were hesitant to trust that retail pharmacy-supported clinical trials will meet patient safety standards and produce data that are “trustworthy, credible, and has integrity to it.”

Benefits and Opportunities

Convenience

Both site personnel and patient interviewees believe that retail pharmacy involvement in clinical trials will offer clinical trial participation convenience. Several interviewees emphasized that more convenient participation would benefit enrollment and retention. Site personnel also suggested that retail pharmacy involvement could help ease typical workload demands.

Awareness

Site personnel and patient interviewees expressed excitement about potential increases in public awareness that pharmacies could bring to clinical research. As one site stated, “They bring in patients who don’t necessarily have insurance and are not necessarily even coming to the pharmacy but may just be there to buy toilet paper and say, ‘I can make $50 doing this clinical trial.’”

Another site interviewee said that retail pharmacies may help minimize the stigma surrounding clinical trials as they become more prevalent in the community.

Participant Diversity

The site personnel interviewed agreed that pharmacies have large databases of patients, are in more diverse areas, and have a larger reach compared to traditional sites—making pharmacy locations more accessible to those who are typically excluded from clinical trials, such as minority, low income, and uninsured patients. However, one site personnel interviewee expressed doubt in the retail pharmacy’s ability to deliver and retain diverse participants for traditional sites: “I do think that they’re going to [attract] that diverse population. But the follow-through afterwards? I think it’s where there’s going to have to be some strategic planning.”

General Perceptions

Lastly, all interviewees—site personnel and patients—noted that they would be willing to collaborate only after retail pharmacies provided more details about their plans to enter and support clinical research. When this study was conducted, all site personnel interviewees indicated that although they had heard about retail pharmacy intent to support clinical trials activity—including those who had spoken directly to pharmacy representatives—little was known about how retail pharmacies planned to execute on their intentions. Patient interviewees had no awareness of retail pharmacies entering clinical research, nor were they aware of retail pharmacy’s involvement in clinical research during the pandemic.

Conclusions

Interviews with a sample of patients and site personnel found retail pharmacy staff competency, data and health privacy, and regulatory compliance and accountability to be the primary barriers/concerns. Convenience, public awareness, and increased patient diversity were noted as the primary benefits/opportunities. It is important to acknowledge that the results of this qualitative study are based on a relatively small, convenience sample of interviews. With many high-level themes identified, future research will look to gather insights from a much larger community of investigative site personnel and patients.

Of the three primary barriers identified, concerns about pharmacy staff competency in clinical research may represent the most significant challenge considering patients’ lack of trust in clinical research and site personnel concern about losing connections with their patients. Retail pharmacies have stated that their relationship with the community and their patients would benefit their ability to enroll patients in clinical trials, and more specifically, their ability to recruit diverse populations (“Walgreens Launches” 2022; Olsen 2023). Concerns raised in these interviews challenges the value proposition promoted by retail pharmacies.

In the future, retail pharmacies may address these concerns by improving efforts to educate clinical research professionals and patients and through partnerships with community physicians. As the most trusted source of health-related information for patients, physician involvement in these models may increase patient trust and could increase awareness of clinical trials among providers (Comis et al. 2009; “Public Perception of Clinical Trials” 2017). This could be valuable to clinical trial participation overall because, historically, a shortage of physicians referring patients to trials has been a barrier to recruitment (Clark et al. 2019).

Site personnel concern over becoming disconnected with their patients and associated decrease in quality-of-care ties into a broader theme in the industry: the push to implement DCT. This was also a concern raised when discussing the ability of retail pharmacies to comply with regulations, with site staff expressing doubt over the safety of patients participating in clinical trials that primarily employ remote oversight.

According to a survey conducted by the Society for Clinical Research Sites, site staff maintain that the push toward DCT reduces personal connections between site staff and patients that are essential to trial success and quality (“Site Perspectives” 2022). This attitude may be a significant barrier to recruiting experienced clinical trialists, with the implementation of DCT approaches representing another core offering of retail pharmacies.

Additionally, the oft-cited shortage of clinical trial staff may further limit the ability of retail pharmacies to hire experienced employees (Sun et al. 2023). The absence of experienced staff, as discussed by interviewees, can threaten trial success and regulatory compliance. Retail pharmacies may benefit from offering onsite oversight positions to improve trial quality, attract experienced staff, and better serve patients.

When speaking of the most significant benefits and opportunities of retail pharmacy involvement, site personnel focused on increasing awareness of clinical trials among the public. According to CISCRP, only 31% of the general population understand clinical trials “very well” (“2021 Perceptions and Insights” 2021). The promotion of ongoing studies at retail pharmacies could be advantageous to not only the recruitment of specific studies, but also to increase education around what clinical trials are and how they function. This could also contribute to shifting patient perceptions of retail pharmacies as solely dispensers of medication.

However, the strongest position to drive retail pharmacy use may be a focus on convenience, which was highlighted extensively in the patient and site personnel interviews. This theme was particularly important for patients, who identified convenience as a primary driver of their willingness to participate. Retail pharmacies may leverage this opportunity by making the patient experience as convenient as possible, which could involve implementing measures such as after-hours visits, designated parking, or private areas to receive care.

Based on input from investigative site personnel and patients, the results of this study help identify opportunities to strengthen retail pharmacy positioning within the clinical research enterprise and offer insights into ways that pharmacies, investigative sites, and patients can more effectively collaborate.

References

• “2021 Perceptions and Insights Study.” 2021. 5. Perceptions and Insights. Center for Information and Study on Clinical Research Participation.
• Alsumidaie, Moe. 2022. “CVS Health Gets into Clinical Trials.” Applied Clinical Trials Online. October 24, 2022. https://www.appliedclinicaltrialsonline.com/view/cvs-health-gets-into-clinical-trials.
• Clark, Luther T., Laurence Watkins, Ileana L. Piña, Mary Elmer, Ola Akinboboye, Millicent Gorham, Brenda Jamerson, et al. 2019. “Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.” Current Problems in Cardiology 44 (5): 148–72. https://doi.org/10.1016/j.cpcardiol.2018.11.002.
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• Olsen, Emily. 2023. “Kroger Health Launches Clinical Trial Site Network.” MobiHealthNews. January 25, 2023. https://www.mobihealthnews.com/news/kroger-health-launches-clinical-trial-site-network.
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