The Role of Retail Pharmacies in the Evolving Landscape of Clinical Research

The world of clinical research is constantly evolving, and one of the most significant shifts in recent years has been the entrance of retail pharmacies into the space. Companies like CVS, Walgreens, Walmart, and Kroger have become leaders in retail clinical research, offering patients more convenient access to clinical trials. However, while these companies benefit the clinical research space, there are some concerns.

CVS has emerged as a leader in the retail clinical research space, with around 100 Minute Clinics that can support clinical research, and has extensive patient and claims data, which can be used to conduct outreach to patients interested in participating in clinical research, and support protocol optimization. The convenience of these locations makes clinical research more accessible to patients, especially those living far from academic medical centers and lacking easy access to clinical trials.

The emergence of retail pharmacies has the potential to make clinical trials more diverse and accessible. These companies can help recruit more diverse and local patient populations by reaching out to patients directly, which is critical as clinical trial populations have historically been skewed toward specific demographics and supplement patient diversity by going global rather than ensuring local patient representation. Additionally, real-world evidence data from pharmacies can be used to design more thorough protocols and studies; biopharmaceutical companies are analyzing patient data using machine learning algorithms to design better studies.

However, despite the potential benefits of retail pharmacy clinical research, patient participation in clinical trials remains low, with only 3% of patients participating in trials (as mentioned by Debbie Profit, Vice President, Clinical Management and Applied Innovation at Otsuka Pharmaceuticals at SCOPE). One of the reasons for this is the inconvenience of clinical trials, with patients having to take time off work, travel to the clinic, and deal with other burdensome requirements. To address this, the industry must focus on making clinical trials more convenient for patients by offering remote participation options and flexible scheduling.

Josh Rose, VP, Head of Clinical Trial Delivery, Site Solutions, and Strategy at CVS, presented the results of a survey CVS conducted on patients at SCOPE 2023, indicating that patients prefer decentralized clinical trial methods, such as having a study site close to their homes, appointment flexibility, and telehealth study visits.

Sid Jain Johnson, Head, Global Development Data Science Strategy & Portfolio at Janssen, emphasized the industry’s recognition of patient burden and the need for change at SCOPE. He shared his experience driving an hour each way to see a specialist and how it deters him from participating in trials. He believes that the industry is acknowledging this challenge and working towards making clinical trials more patient-centered.

Another potential benefit of retail pharmacies in the clinical research space is the ability to offer more personalized care to patients. Retail pharmacists are often the first point of contact for patients seeking medical advice and can play a critical role in identifying potential clinical trial candidates. By working closely with clinical trial teams, retail pharmacists can help ensure patients receive the necessary information and support to participate in clinical trials. This personalized approach to patient care can help build trust and improve patient outcomes, ultimately benefiting the entire healthcare system.

In my opinion, the role of retail pharmacies in the evolving landscape of clinical research is not without controversy. For example, the fact that these enterprises are new at clinical trials brings clinical trial quality oversight and data quality concerns that could compromise the safety and efficacy of new treatments. There are also concerns about potential conflicts of interest, as retail companies have a financial stake in revenue generation since they’re publicly held and may compromise patient safety or data quality for financial gain; alternatively, privately-held study sites may focus less on finances and more on conducting quality clinical trials. "Retail pharmacies face challenges such as limited infrastructure and staffing, potential conflicts of interest, and risks related to data privacy, but their large patient pools and accessibility make them valuable for clinical trials. With appropriate training and upgrades, pharmacies can be a cost-effective alternative to traditional clinical sites," said Darshan Kulkarni, PharmD, MS, Esq., Principal Attorney at the Kulkarni Law Firm. While retail pharmacies can help recruit diverse patient populations, barriers to participation still need to be addressed, such as patient burden and the inconveniences stemming from poor protocol design, a sponsor’s responsibility.

In summary, retail pharmacies like CVS, Walgreens, Walmart, and Kroger have the potential to transform the clinical research industry by offering more convenient access to clinical trials and helping to recruit diverse patient populations. However, the industry must address the patient burden by providing more convenient and accessible options to increase patient participation. Also, I would recommend sponsors evaluate the risks involved with data quality collected in these settings and potential conflicts of interest to ensure patient safety and data integrity. The quality of data collected in these settings and potential conflicts of interest must also be addressed to ensure patient safety and data integrity. By doing so, clinical trials can become more representative of the patient population, leading to better treatments and medications.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and regular contributor to Applied Clinical Trials.