BARDA funds first pharmacy-based decentralized clinical trial under Project NextGen
Project with Walgreens brings clinical trials to neighborhoods, increases access and diversity
In an effort to increase access to clinical trials, the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) will provide $25 million in Project NextGen funding to Walgreens to conduct a decentralized clinical trial. The agreement is BARDA’s first with a major retail pharmacy to use this type of clinical trial approach, which is expected to enable more people of diverse backgrounds, such as age and ethnicity, to participate.
“Today’s announcement is the latest demonstration of our commitment to ensuring that health equity is built into all of our preparedness, response and recovery activities,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “ Americans are diverse. Clinical trials should be, too. We want to make clinical trials easy to access so that more people who want to participate can do so.”
The award was made through BARDA’s Rapid Response Partnership Vehicle, managed by Advanced Technologies International. Under the agreement, Walgreens will conduct a Phase IV vaccine correlate of protection clinical study using an FDA-authorized or licensed COVID-19 vaccine.
Correlates of protection, also known as correlates of immunity, are measurable markers of immunity that correlate with protection against disease. Establishing correlates helps scientists and others understand more about how the protective immunity of vaccines lasts over time, which in turn informs public health guidelines. Correlates of protection also help scientists evaluate vaccines, providing information on how to improve vaccines, and potentially saving time and reducing the cost of clinical trials for development of future vaccines.
Currently, to participate in a vaccine clinical trial, volunteers often travel to hospitals, universities or other central locations established as clinical trial sites that usually are far from their homes. Decentralized settings include health care environments that Americans routinely use. For this study, approximately 20 Walgreens pharmacy stores will serve as clinical trial sites in urban, suburban, and rural communities across the United States. To recruit study volunteers, Walgreens will provide information on how and where to participate in the study.
Through this study, BARDA aims to advance decentralized clinical trial capabilities that improve access. To demonstrate that this approach works as well as traditional centralized clinical trials, the study will identify correlates for updated doses of the vaccine. Learning what aspects of decentralized clinical trials work for vaccine correlate of protection studies can enable larger, more diverse future studies that can be useful in identifying any correlates of protection for different age groups, health conditions, or other factors. This level of information can support future vaccine policies and recommendations.
“At BARDA, we are committed to advancing clinical trial capabilities that remove barriers to clinical trial participation and improve accessibility,” said BARDA Director Gary Disbrow, Ph.D. “Enabling diverse representation and data in clinical trials will help us to develop products that reflect the people and communities that need them most.”
With this approach, the study can demonstrate the utility of partnering with organizations that have geographically diverse, decentralized sites, particularly where patients already seek care. This approach gives medical product developers the opportunity to recruit, enroll, and retain a more diverse set of volunteers participating in future clinical studies.
During the COVID-19 pandemic response, pharmacies and retail clinics were essential to the distribution of vaccines, therapeutics, and diagnostic tests. Many Americans received at least one vaccination at a
retail pharmacy. Conducting clinical trials in decentralized settings also enables the clinical trial to collect data that reflect real-world use, as well as diverse and harder-to-reach populations and locations.
This effort is being funded under
Project NextGen, a $5 billion program led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to accelerate and streamline development of the next generation of innovative COVID-19 vaccines, therapeutics, and enabling technologies. To date, BARDA has provided approximately $2.6 billion in Project NextGen funds to industry partners to achieve these goals. Visit the
Project NextGen portfolio page to learn more.
Learn how to become an RRPV Consortium member:
https://www.rrpv.org/how-to-join/
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