New Insights on How Walgreens Clinical Trials Operate

In a conversation with Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, we explore the company’s cutting-edge strategies to maximize its expansive pharmacy network for clinical trials conducted at retail pharmacies. This interview illuminates the ways in which Walgreens integrates technological advancements and engagement tactics to revolutionize the process of enrolling participants and decentralizing clinical trials. By focusing on improving both representation and accessibility, Walgreens clinical trials positions itself as a pivotal player in the field of clinical research, aiming to bring about significant advancements in how clinical trials are conducted and how participants are sourced.

Moe Alsumidaie: How does Walgreens utilize its extensive pharmacy networks to identify and recruit patients in clinical trials?

Ramita Tandon: Walgreens clinical trials leverages its widespread pharmacy network by strategically using advanced technology, specifically AI tools and algorithms, to meticulously sift through its extensive patient database of 130 million individuals. This sophisticated technological framework enables the company to categorize and analyze patient insights based on critical demographic and health-related criteria. Walgreens’ method enables precision in identifying clinical trial participants, allowing for targeted recruitment that addresses the diverse needs of patients and reaches underserved or underrepresented communities. Thus, it fills critical gaps in clinical research representation. Moreover, Walgreens’ approach emphasizes a commitment to ethical standards and patient protection. By prioritizing patients’ consent and privacy in the recruitment process, Walgreens clinical trials upholds its responsibility to its primary constituents—the consumers and patients who trust the pharmacy with their health care needs.

Moe Alsumidaie: Can you describe the technology and infrastructure setup supporting the hybrid decentralized clinical trial model?

Ramita Tandon: Integrating technology and infrastructure to support a hybrid model for clinical trials is a cornerstone of our innovative approach. In response to the dynamic demands of the modern world, particularly highlighted by the recent pandemic, we have developed a flexible clinical trial operating model that encompasses in-store, hybrid, and entirely home-based trials.

• In-Store Setup: Our in-store setup includes fully compliant clinical trial research centers that handle low-complexity services, ensuring participants can access necessary in-person interventions without compromising safety or regulatory standards.
• Hybrid Setup: For hybrid scenarios, we employ a mix of on-site visits and remote interactions facilitated by advanced technology platforms provided by our industry partners. This blend of approaches ensures that each clinical trial can be tailored to meet its unique requirements while maximizing participant accessibility and engagement.
• Home-Based Setup: Our entirely home-based model represents the pinnacle of flexibility in clinical trial recruitment, allowing participants to engage in studies from their homes. This model is supported by a robust infrastructure that includes telemedicine capabilities, remote monitoring technologies, and digital consent processes, all integrated into a seamless workflow that respects the participant’s time and privacy.

By leveraging these advancements in clinical trial infrastructure and supporting technologies, we can reach a more comprehensive array of participants, including those in remote or underserved areas, and enhance the efficiency and effectiveness of the clinical trial process.

This includes organizing events like Rural Health Day, utilizing digital screens for informative displays, distributing flyers with information in patients’ pharmacy bags, and initiating direct conversations between pharmacists and patients. These efforts are tailored to inform and dismantle clinical trial apprehensions, making participating in clinical research more approachable for marginalized or underserved communities.

Moreover, Walgreens’ initiative does not stop at spreading awareness; it actively seeks to empower communities by making them an integral part of the conversation around clinical trials. From its successful engagement strategies during the COVID-19 vaccination campaign, Walgreens has learned the importance of making educational resources accessible and relatable.

By addressing concerns, debunking myths, and highlighting the potential benefits of clinical trial participation, Walgreens is paving the way for a more inclusive and diverse clinical research environment. This approach fosters a sense of trust and belonging among traditionally mistrustful communities and significantly contributes to the broader goal of making clinical trials more representative of the population at large.

Moe Alsumidaie: How does Walgreens navigate privacy and consenting issues when leveraging patient data for Clinical Trial Recruitment?

Ramita Tandon: In navigating the complex landscape of patient privacy and consent in the context of clinical trials, Walgreens has established a comprehensive compliance framework that adheres strictly to FDA regulations and HIPAA guidelines. This framework ensures the protection of patient information and the integrity of the clinical trial process, bolstering the trust patients place in Walgreens as a healthcare provider. Consent is crucial in this process, serving as the foundation of patient participation in clinical research. Walgreens employs various outreach methods to inform patients about trial opportunities, allowing patients to exercise their right to opt in or opt out with a complete understanding of participation. This approach respects patient autonomy and ensures that consent is informed and voluntary, addressing potential privacy concerns upfront.

Is Walgreens using eConsent technology? How are you addressing technology discrimination?

eConsent platforms have been particularly effective in streamlining this process, offering patients a convenient and secure method to express their willingness to participate in research; however, we always have our patients’ needs at the forefront. For instance, elderly patients or those without reliable internet access can consent in person, where they can engage directly with healthcare professionals to ask questions and gain a thorough understanding of the trial. This personalized approach facilitates a deeper level of informed consent and reinforces Walgreens’ commitment to ethical standards and patient-centered care. By ensuring that all patients, regardless of their background or access to technology, can navigate the consent process in a way that suits their needs, Walgreens upholds the highest standards to ensure patient inclusion in clinical trials.

Moe Alsumidaie: How do decentralized clinical trial models impact the speed and efficiency of clinical trials compared to traditional models?

Ramita Tandon: As employed by Walgreens, decentralized clinical trial models stand at the forefront of transforming the traditional approach to clinical research by bringing trials directly to patients rather than the other way around. This innovative approach significantly accelerates the recruitment process and enhances participant diversity by tapping into Walgreens’ direct access to a vast and varied patient population. By integrating clinical trials into the routine healthcare services provided by pharmacists, Walgreens clinical trials not only simplifies the process of trial participation for patients but also addresses historical barriers to participation. This model has proven especially effective in communities of color, where trust in the healthcare system may be tenuous, and access to traditional clinical trial sites may be limited. The success of this approach is evidenced by Walgreens’ ability to facilitate quicker adoption and participation in clinical trials, demonstrating the potential of retail pharmacies to serve as powerful conduits for engaging underrepresented populations in clinical research.

Moreover, this shift towards decentralized trials highlights the importance of patient-centricity in clinical research, a principle that has gained momentum in recent years. By leveraging its nationwide pharmacy network, Walgreens enhances the efficiency of clinical trials and improves the overall experience for participants. This method reduces the need for frequent travel to distant trial sites, a common deterrent for potential participants. It allows for a more inclusive recruitment strategy that mirrors the demographic diversity of the broader population. The positive outcomes of Walgreens’ decentralized trial model, including increased enrollment rates among traditionally underrepresented groups, offer a compelling case for adopting similar strategies across the clinical research industry. This approach speeds up the research process and enriches data quality by including a broader, more diverse participant base, ultimately contributing to more equitable and effective healthcare solutions.

Moe Alsumidaie: What have been the biggest challenges in operating this clinical research initiative at Walgreens, and how do you plan to scale this model?

Ramita Tandon: Despite federal guidelines advocating for more representation within clinical trials, there remains a notable gap in the actual inclusion practices of many clinical trials. This disconnect highlights the need for a paradigm shift towards more inclusive research designs that genuinely reflect the diverse makeup of the population. Walgreens clinical trials is actively working to bridge this gap by engaging in dialogue with its partners, advocating for adopting trial designs that are compliant with regulatory expectations and reflective of the real-world diversity of patients who benefit from clinical research.

On the operational front, Walgreens grapples with the practical challenges of implementing a decentralized clinical trial model across varied demographic and geographic landscapes. Barriers such as limited broadband access and varying degrees of digital literacy can significantly hinder participation in clinical trials, especially in rural or underserved communities. Walgreens clinical trials is committed to addressing these obstacles head-on by educating its partners on these issues and exploring innovative solutions that make clinical trials more accessible. This includes leveraging its extensive pharmacy network to facilitate in-person engagement and support and employing alternative communication strategies to reach potential participants.

Moe Alsumidaie: Looking towards the future, what are Walgreens’ aspirations in the clinical trial space?

Ramita Tandon: As Walgreens clinical trials looks toward the future in the clinical trial space, the company is set on addressing and overcoming the persistent challenges of representation and accessibility in clinical research. The vision is expansive and inclusive, aiming to democratize access to clinical trials across diverse populations and geographies. With an impressive track record of over 30 trials underway and numerous case studies highlighting its model’s success, Walgreens is poised to deepen its commitment. The strategy involves continuously building the infrastructure and processes necessary to reach patients where they are, leveraging its vast retail pharmacy network. This approach simplifies the recruitment process and personalizes the trial experience, making it more accessible and less intimidating for potential participants.

Further, Walgreens clinical trials is determined to strengthen and expand its partnerships within the clinical trial ecosystem. Recognizing the importance of collaboration in achieving its mission, the company seeks to forge new alliances and nurture existing ones with pharmaceutical companies, technology providers, and community organizations. These partnerships are vital for bringing a more comprehensive array of trials to Walgreens’ customer base, enhancing the diversity of research opportunities available through its pharmacies. By showcasing the effectiveness of its model through real-world evidence and success stories, Walgreens clinical trials aims to position itself as a key player in transforming clinical trials, ensuring they are more representative, accessible, and patient-centric.