Retail Pharmacies and Decentralized Clinical Trials: The Path Forward Despite Challenges

Decentralized clinical trials (DCTs) are revolutionizing the research landscape by bringing trials directly to patients, enhancing accessibility. A potential key player in this transformation is the retail pharmacy industry. Despite recent developments, such as the closure of CVS Health's clinical trials unit, it's not yet over for retail pharmacies in clinical trials. With their extensive network and infrastructure, retail pharmacies like Walmart, Kroger, and Walgreens can significantly improve patient access to clinical trials. This article will discuss how these retail pharmacies can harness their resources to promote diversity and inclusion, enhance patient accessibility, embrace technology for virtual care, and prioritize patients in clinical trials. By adopting a more patient-centric approach and adhering to FDA's guidance on DCTs, retail pharmacies can contribute to a more inclusive and accessible clinical trial landscape, proving that the potential of retail pharmacies in clinical trials is far from exhausted.

Decentralizing clinical trials through retail pharmacies

Retail pharmacies can serve as decentralized sites for clinical trials, making participation more convenient for patients. FDA guidance recommends using local healthcare providers for more accessible assessment and monitoring of trial participants, which can be facilitated through retail pharmacies' existing infrastructure. For example, Walmart operates over 4,700 stores across the US, with a majority of Americans living within 10 miles of a Walmart store. By using retail pharmacy networks to facilitate patient enrollment and participation in DCTs, patients can access trials more conveniently, reducing the need for long-distance travel and improving patient retention.

Promoting diversity and inclusion through retail pharmacies

Promoting diversity and inclusion is another critical aspect of the clinical trials industry. FDA emphasizes the need for diverse patient representation in clinical trials to ensure trial outcomes apply to a broader population. Retail pharmacies can collaborate on initiatives encouraging diverse patient representation, leading to more comprehensive and relevant research outcomes.

Enhancing patient accessibility through retail pharmacies

Retail pharmacies can make clinical trials more accessible to a wider range of people, particularly regarding minority representation. FDA guidance recommends using electronic informed consent (eConsent) in DCTs to facilitate informed decision-making by trial participants while ensuring the process complies with regulatory requirements. Retail pharmacies can provide the necessary infrastructure for eConsent, making it more convenient for patients to participate in trials.

Embracing technology for virtual care in retail pharmacies

Retail pharmacies can leverage technology to facilitate remote monitoring, data collection, and communication between patients and researchers. FDA guidance underscores the importance of eClinical technologies in managing various trial-related activities. Retail pharmacies, such as Walgreens, can leverage existing virtual care assets, which can help streamline the DCT process and make it more efficient.

A focus on putting the patient first

Retail pharmacies can play a pivotal role in adopting a patient-first approach by enhancing the patient experience and reducing participant burden. They can provide patients with easy-to-understand information about the trial, its risks, and its benefits. They can also leverage eConsent by providing patients with engaging resources such as videos or educational materials to help them make informed decisions about participation.

The case of CVS: A lesson, not a conclusion

The recent closure of CVS Health's clinical trials unit serves as a lesson for other retail pharmacies considering venturing into the clinical trials industry. The decision could have been attributed to various factors, including strategic realignment, competition, operational hurdles, financial implications, and industry trends. However, this should not be seen as a conclusion that retail pharmacies cannot succeed in clinical trials. Instead, it should serve as a reminder that careful evaluation of strategic fit, competition, infrastructure, financial constraints, and industry trends is crucial when venturing into new market areas.

The path forward: It's not over for retail pharmacies in clinical trials

Despite the challenges, it's not yet over for retail pharmacies in clinical trials. The increasing demand for DCTs and the apparent growth of the clinical research sector present an opportunity for retail pharmacies to redefine their role in healthcare and contribute to the advancement of clinical research. Retail pharmacies can leverage their extensive networks, established infrastructure, and technological capabilities to improve patient access, promote diversity and inclusion, and support clinical trial expansion into minority communities.

FDA's guidance on decentralized clinical trials emphasizes the importance of incorporating technology and innovative approaches to make clinical trials more patient-centric and efficient. Retail pharmacies are uniquely positioned to support these efforts, particularly when it comes to virtual care.

The key to success lies in a long-term commitment to clinical research, significant investment in infrastructure and training, and a patient-centric approach. Retail pharmacies need to balance their core business operations with the rigorous requirements of clinical trials. They must also be prepared to face competition from traditional clinical trial sites, such as hospitals and academic medical centers with established infrastructures and specialized equipment.

In conclusion, the closure of CVS's clinical trials unit should not be seen as a sign that retail pharmacies cannot succeed in the clinical trials industry. Instead, it should serve as a reminder of the challenges of venturing into new market areas. With careful planning, strategic investment, and a patient-centric approach, retail pharmacies can make clinical trials more inclusive and accessible. As the clinical trials industry continues to evolve, it is essential to prioritize inclusivity and accessibility to ensure that all patients have the opportunity to participate in research that can improve their health and well-being. By working together, researchers, healthcare providers, and retail pharmacies can make this vision a reality.

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.