Walgreens New Decentralized Clinical Trials Model in Action

The 2024 SCOPE Summit, a pivotal event in clinical trials, showcased innovative strategies to transform patient recruitment and trial conduct. At the forefront of these discussions was John Campbell, Head of Decentralized Trials for Walgreens, who shared profound insights into leveraging retail pharmacy networks to enhance trial accessibility, diversity, and efficiency through decentralized clinical trial (DCT) models. This article delves into the key themes of Campbell’s presentation, highlighting Walgreens’ pioneering approach to patient recruitment and study conduct through its vast retail pharmacy infrastructure.

Making Clinical Trials More Accessible and Representative

Campbell began by addressing the critical challenges facing clinical trials today, notably the issues of access and representation. With only a fraction of the population participating in clinical trials, resulting studies often lack diversity, skewing towards whiter and more male demographics. With nearly 9,000 locations and 130 million active patients, Walgreens is positioned uniquely to tackle these challenges. “90% of individuals from underrepresented groups…live within 5 miles of a Walgreens,” said Campbell. The company utilizes its extensive data on patient demographics, prescriptions, and health services to create targeted recruitment campaigns. This strategy not only enhances trial accessibility but also ensures a more representative participant base, especially among underrepresented communities. “We have the responsibility of serving millions of patients across the country who provide us with insights that allow us to make clinical research a care option for them,” said Campbell

Innovating Patient Recruitment through Retail Pharmacies

Much of the presentation was dedicated to Walgreens’s innovative patient recruitment model. Campbell detailed a three-step process involving patient identification, engagement, and pre-screening, all facilitated by the company’s comprehensive data resources. By analyzing prescription data, health services, and social determinants of health, Walgreens can identify potential participants with remarkable precision. This method has proven effective in rapidly assembling cohorts for various studies, from diabetes to Alzheimer’s disease, demonstrating the potential to streamline recruitment processes significantly.

Enhancing Study Conduct with a Hybrid Clinical Model

Walgreens’ innovative approach extends beyond recruitment to the conduct of clinical trials. Emphasizing flexibility, the company has developed a hybrid clinical model that combines virtual, in-store, and hybrid trials. Campbell said, “Our clinical model is really based off the idea that we should take every resource that we can out of a physical location and centralize it.” This model allows for a more adaptable and efficient trial process, accommodating various study designs and therapeutic areas. Central to this approach is using technology to manage patient cohorts, campaign outreach, and data collection, ensuring consistent quality and regulatory compliance across all studies.

Case Studies: Demonstrating Success and Scalability

Campbell provided compelling case studies to illustrate the effectiveness of Walgreens’ methods. One notable example involved a vaccine study that required rapid recruitment across numerous sites and achieved a recruitment target of 5,000 patients in under 4.5 months. By adjusting outreach strategies and leveraging in-store resources, Walgreens was able to meet ambitious enrollment goals within a tight timeframe. Another example highlighted the company’s ability to recruit a significantly higher percentage of Hispanic/Latino patients for an Alzheimer’s disease study, showcasing the potential to achieve more diverse and representative study populations.

Looking Ahead: Expanding Impact and Addressing New Challenges

In his concluding remarks, Campbell outlined Walgreens’ future directions, emphasizing the continued focus on diagnostics, early cancer detection, vaccines, and cardio-metabolic diseases. The company aims to build on its early successes by scaling up its operations and exploring new therapeutic areas while maintaining its commitment to reducing patient burden, minimizing costs, and speeding up the time to last patient in.

Summary

The insights shared by John Campbell highlight the transformative potential of leveraging retail pharmacies in clinical trials. Walgreens’ innovative approach to patient recruitment and trial conduct offers a promising path toward more accessible, representative, and efficient clinical studies. As the company continues to refine its strategies and expand its reach, the implications for the future of clinical research are profound, promising to reshape the landscape of trial design and participant engagement for years to come.