The retail pharmacy giant and the Biomedical Advanced Research and Development Authority hope to make decentralized clinical trials more accessible and representative of the U.S. population.
The U.S. Biomedical Advanced Research and Development Authority on Monday announced that it has entered into a $100 million partnership with retail pharmacy giant Walgreens to improve access to decentralized trials by addressing barriers to representation in clinical research.
Under the five-year contract, the Biomedical Advanced Research and Development Authority (BARDA) will have access to Walgreens’ clinical trials ecosystem, which “has proven effective in making trials more accessible and representative of the U.S. population,” according to the announcement.
Ramita Tandon, chief clinical trials officer at Walgreens, said that working with BARDA is a “privilege” for the company, noting that the contract will help “strengthen clinical research in the U.S. through a decentralized model.” Walgreens will leverage its large network of community pharmacies and its “compliant and secure clinical trial platform,” making “clinical research an integral part of a patient’s healthcare journey,” Tandon said.
Since launching in 2022, Walgreens’ trials network has reached more than five million patients, according to the retail giant. While around 80% of trials fall short of their enrollment goals, which results in lengthy and costly delays, Walgreens contends it has “consistently” met recruitment targets and surpassed national averages for diversity in enrollment.
Walgreens’ decentralized system uses a comprehensive approach to patient recruitment and engages study participants where it is most convenient for them, according to the announcement, making the retailer an “ideal” partner to boost decentralized clinical research.
Walgreens is also working with BARDA on a Phase IV observational COVID-19 study designed to help boost U.S. preparedness for future outbreaks.
Decentralized clinical trials have picked up steam in recent months, especially after the COVID-19 pandemic demonstrated the need for quicker drug discovery. However, regulatory hurdles remain which could stunt advancement of the field.
In a January 2024 BioSpace article, Chris Scheefer, North American lead for intelligent industry at Capgemini Americas, a clinical development services firm, highlighted the challenges for decentralized trials (DCTs)—and potential solutions.
“Companies will not only have to manage a network of care providers, but their stakeholder ecosystem for most DCTs [decentralized clinical trials] also involves insurers, medical device companies, trial service providers and numerous technology vendors,” Scheefer said, noting that staffing shortages are already emerging. The “volatility of clinical trial regulation” worldwide is likewise a roadblock.
Scheefer contends that several strategies are needed to enable decentralized trials, including reskilling and upskilling employees, boosting companies’ cyber capacity, shoring up data practices and protocols, as well as enlisting industry experts to assess the legal and regulatory landscape for DCTs.
