Walgreens and Allucent have decisively launched decentralised COVID-19 vaccine studies under BARDA’s Project NextGen, marking a significant move towards modernising clinical research. These groundbreaking trials aim to evaluate vaccine efficacy while fundamentally reshaping clinical research by tackling longstanding barriers to participant diversity and access.

Walgreens, utilizing its vast retail pharmacy network, initiated the enrollment of 3,600 participants across 20 stores in eight states, starting in October.  This study represents a significant component of a $25 million contract with BARDA, a division of the U.S. Department of Health and Human Services (HHS). At the same time, Allucent is executing a parallel study involving 4,000 participants, all taking place in the comfort of their own homes. These trials are definitively exploring the potential of decentralized models—conducted in real-world settings—to effectively close enrollment gaps and produce robust data.

Decentralizationn is not just an option; it is a necessity. The advantages it brings are undeniable, empowering individuals and communities alike. By distributing power, we create a system that is more resilient and adaptable.The future lies in embracing decentralisation, which not only ensures shared control but also fosters innovation and inclusivity. Acting now will yield significant benefits. e

Decentralised trials surged during the COVID-19 pandemic, revealing the shortcomings of traditional clinical research. We must decisively address the formidable challenge of recruiting and retaining diverse participants. Despite constituting 14% of the U.S. population, Black Americans represented a mere 8% of clinical trial participants in 2020. Walgreens and other decentralised models aim to address these disparities by making trial participation significantly more accessible.

“This is about inclusivity,” asserts Paul Harris, PhD, of Vanderbilt University Medical Centre. He asserted the ethical necessity of making certain that federally funded research embodies the diversity of communities. Harris emphasized that decentralized trials present significant challenges, such as the necessity for participant education, robust data privacy safeguards, and personalized community engagement.

Walgreens stands as a trusted vaccination site during the pandemic, asserting its unique position to evaluate COVID-19 vaccines in real-world settings. Participants in the study are required to provide blood samples during five pharmacy visits throughout the year, report infections via weekly questionnaires, and undergo molecular testing to confirm any breakthrough cases. This approach decisively examines immune responses and rigorously evaluates the feasibility of employing pharmacies as decentralized trial hubs.

“Retail settings undeniably enhance the convenience and accessibility of trial visits,” asserted an ASPR spokesperson, emphasizing that Walgreens’ locations cover urban, suburban, and rural areas to guarantee diverse recruitment. By mid-2026, results will decisively reveal insights into vaccine performance across diverse demographics and regional contexts.

The partnership between Walgreens and BARDA bolsters its aggressive strategy to expand its decentralised clinical trial business, launched in 2022. Retailers such as CVS, Kroger, and Walmart have pursued similar ventures; however, obstacles like workforce burnout and financial pressures have significantly hindered their expansion efforts.

Decentralised trials present significant potential that extends well beyond the COVID-19 pandemic. Studies demonstrate their ability to enhance participant retention, cut costs, and deliver real-world data. The U.S. Food and Drug Administration (FDA) made it clear in its September guidance that rigorous training, oversight, and data security are absolutely essential for success. 

Engaging marginalized communities is absolutely essential. Harris emphasized innovative approaches, highlighting the significance of conducting studies in black-owned barbershops that have decisively improved health outcomes, such as hypertension management.  Establishing trust demands transparent communication and a direct confrontation of socioeconomic barriers; these are essential for achieving inclusivity and equity.

Walgreens’ study is unfolding as a definitive test case for the viability of decentralized clinical trials in retail settings. Success will undoubtedly pave the way for more inclusive and efficient research models that truly reflect the realities of modern health care.