With CVS exiting the clinical trials arena through its clinical trials unit closure, other retailers are continuing to pursue clinical trials. In this interview, we’re joined by Jim Kirby, Chief Commercial Officer at Kroger Health, to shed light on Kroger’s groundbreaking entry into the clinical trials arena. Kirby provides valuable insights into Kroger’s collaborative approach, commitment to diversity, and dedication to ensuring the success of their clinical trials unit.

Moe Alsumidaie: Could you elaborate on the collaborative approach Kroger is adopting in relation to the clinical trials arena?

Jim Kirby: At Kroger Health, we firmly believe in the power of collaboration, especially in a field as expansive and nuanced as clinical trials. Our strategy relies heavily on working hand in hand with the local ecosystem. We recognize that each local institution is an expert in its field, and we want to create an environment where they feel part of the Kroger team and together we are working toward the same goals. We strive to build on existing relationships with health systems, payers, non-profits, and other stakeholders within the communities we serve. We see tremendous value in working together to boost community involvement in clinical trials.

MA: Are there any key insights or lessons you’ve garnered from other retail health pharmacies operating in the clinical trial sector? How are these insights shaping Kroger’s strategy in this domain?

JK: Regarding strategy, our main priority is quality. We want to ensure that we can do exactly what we say we can, and part of that is our commitment to enrolling patients from diverse backgrounds. We must incorporate the diversity of the local communities we serve in our trials, which means engaging with individuals who have not traditionally been part of the clinical trial process. Because our involvement in the clinical trials space is new, our perspective and tools will also seek to evolve and enhance over time.

MA: With the need for more local diversity and inclusivity in clinical trials increasingly acknowledged, how does Kroger plan to ensure the representation of minorities and underserved communities in your trials?

JK: The need for increased diversity and representation in clinical trials is an issue we’re very much attuned to at Kroger. In fact, one of our key strategic goals is to enroll patients from various backgrounds, ensuring our trials reflect the diversity of the communities we serve. This includes reaching out to those traditionally underserved in clinical trials. As a retailer trusted by many in these communities, we’re uniquely positioned to build upon this trust and engage these populations effectively. We will be working with local community boards, non-profits, and health systems to enhance our outreach and engagement efforts and create an environment where diverse participation in clinical trials is not just possible but encouraged. Our ultimate goal is to make clinical trials accessible and beneficial to everyone, regardless of race, ethnicity, or socioeconomic background.

MA: Can you speak a bit more about Kroger’s financial commitment and long-term investment in ensuring the clinical trials unit at Kroger is successful over time?

JK: As you can imagine, launching a clinical trials unit is a substantial undertaking that requires significant investment. We’re making initial investments to get our clinical trials off the ground and learn from early pilot projects. We’re staffing up for these experiences and continuously evaluating our processes to understand where we need to invest further, whether it’s in technology or human resources. Once we have concrete insights from these pilots, we’ll be better equipped to decide the next investment stage needed to scale our efforts effectively.

MA: Given the FDA’s recent push toward decentralizing clinical trials, how does Kroger plan to align with this trend?

JK: We aim to use digital health technologies to facilitate a decentralized approach, enabling us to reach more patients while maintaining the high quality of our clinical trials. Moreover, we’re engaging local healthcare providers and research teams in quality assessments, crucial for ensuring patient safety and data integrity.

MA: Can you give us an idea of the therapeutic areas you plan to focus on? How can Kroger’s capabilities as a retail pharmacy be applied to these areas?

JK: As a retail pharmacy with a strong focus on healthcare, we’re setting our sights on primary care, internal medicine, and chronic disease states, which include conditions like heart failure, diabetes, cardiovascular disease, pulmonary diseases, and mental health issues. These are conditions typically treated in a primary care setting. We are also particularly interested in preventive health, including vaccinations and nutrition. That being said, we’re conscious of our limitations. For example, we likely won’t engage with infusible drugs or rare diseases at community pharmacies. However, we’re keenly interested in medical devices as they often transcend a single therapy.

MA: How does Kroger’s principal investigator (PI) oversight infrastructure ensure that patients are safe and that data quality is uncompromised?

JK: Ensuring patient safety and data quality is at the heart of everything we do at Kroger Health. The PI works closely with the nurse practitioners and sub-investigators at our clinic locations, providing comprehensive oversight. They communicate regularly, ensuring alignment and coordination. When it comes to the patients we’ve enrolled, our PI is thoroughly involved in all elements of the conduct of the trial. We’re taking a very methodical approach to this, going above and beyond the requirements to ensure we don’t compromise on patient safety and data quality.

MA: Are there any key takeaways or insights you would like to share about Kroger’s efforts in clinical trials?

JK: The major takeaway from our efforts so far is that successful clinical trials require robust and thorough recruitment and enrollment processes and equally thorough strategies for retaining participants. We have a unique opportunity to make a real difference with Kroger Health and our community-focused health locations. Many of these communities haven’t traditionally had access to clinical trial opportunities, and by giving them this access, we’re fostering a completely different level of trust than that found in major academic institutions. With 90% of the U.S. population living within five miles of a pharmacy, and 51% of all Kroger stores located in what would be considered socially vulnerable areas, our clinical trial sites are poised to open the doors to patient cohorts that did not have access to clinical trials previously. This proximity and trust will increase our clinical trials’ enrollment and retention success rate. It’s all about serving and benefiting the community.

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.