Walgreens and BARDA Partner to Increase DCT Innovation
Valued up to $100 million, the collaboration will conduct clinical trials over a five-year period with the goal of strengthening decentralized models.
Walgreens and the Biomedical Advanced Research and Development Authority (BARDA) have announced a strategic partnership to increase innovation in decentralized clinical trials (DCTs). This new collaboration is part of the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program.1
According to a press release, D-COHRe is designed to strengthen US decentralized clinical research capabilities to support development of FDA-regulated products, enhance clinical innovation to execute more efficient and relevant clinical research, and evaluate other medical countermeasures in real world environments that may be used in a public health emergency.
This new partnership with BARDA, which is part of the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS), will utilize Walgreens’ clinical trial ecosystem. Since its launch in 2022, the ecosystem has reached more than five million patients.
“It is a privilege to continue our partnership with BARDA to strengthen clinical research in the US through a decentralized model in a community pharmacy setting like Walgreens,” Ramita Tandon, chief clinical trials officer at Walgreens said in the press release. “Our network of community pharmacies and our compliant and secure clinical trial platform enables us to pioneer a comprehensive solution to make clinical research an integral part of a patient’s healthcare journey, especially when it is most critical for the well-being of our country, during a public health emergency.”
Earlier in July, Walgreens announced it had received a project award valued up to $25 million through the Rapid Response Partnership Vehicle (RRPV), a consortium funded by BARDA. With the award, Walgreens is planning to conduct a Phase IV novel COVID-19 decentralized clinical study. The trial will focus on assessing correlates of protection, or responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.2
Funding for the award was received under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new vaccines and therapeutics, providing broader and more durable protection for COVID-19 than the first-generation COVID vaccines and medicines.
“We are honored to be selected by BARDA and its RRPV for this important study as this is a step forward to utilize public and private partnerships to bring clinical trials into more communities across the country,” Tandon said in an earlier press release. “With our experience in immunizations and trusted relationship with millions of patients and customers, Walgreens is uniquely positioned to support this critical research. As the only retail pharmacy with a national decentralized clinical trial infrastructure and dedicated clinical research staff, we are committed to helping enhance public health preparedness.”
Once again, Walgreens is planning to utilize its trial ecosystem for patient recruitment. For this new study, it will enroll up to 4,000 participants across 20 retail pharmacy locations nationwide.
References
1. Walgreens and BARDA Form Strategic Partnership to Strengthen Decentralized Clinical Trials Model and Reporting. News release. Walgreens Boots Alliance. August 19, 2024. Accessed August 20, 2024. https://www.walgreensbootsalliance.com/news-media/press-releases/2024/walgreens-and-barda-form-strategic-partnership-strengthen
2. Walgreens Receives BARDA Project NextGen Award to Conduct Novel COVID-19 Decentralized Clinical Study. News release. Walgreens Boots Alliance. July 23, 2024. Accessed August 20, 2024. https://www.walgreensbootsalliance.com/news-media/press-releases/2024/walgreens-receives-barda-project-nextgen-award-conduct-novel-covid
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
