New partnerships strengthen decentralized clinical trial capacities in public health emergencies

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), has announced the first three awards for the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. D-COHRe is working with new partners to build sustainable and accessible decentralized clinical trials (DCTs) that enable rapid and flexible clinical validation of new technologies and approaches to pandemic preparedness. These five-year partnerships are an important step in advancing innovative DCT capabilities.

Nearly 80% of trials fail to enroll participants within their timelines, often resulting in billions of dollars in annual delays. With only 5% of the U.S. population participating in clinical trials, there is a clear need to improve access and representation in clinical research.

The COVID-19 pandemic has further accelerated the use of decentralized healthcare, including telemedicine, retail clinics, wellness apps, and more. At the same time, the pandemic has highlighted the need to modernize clinical trials—specifically, the need to move from traditional, centralized clinical trials to more patient-focused, decentralized clinical research that allows participation from more sites to rapidly validate and distribute broad ranges of medical countermeasures (MCMs), including new diagnostics, vaccines, and antivirals.

BARDA’s first three strategic D-COHRe partners are:

• Allucent: Provides DCT testing capabilities including multiple site models, data collection, electronic clinical testing technology capabilities, and DCT expertise to improve patient centricity and increase access for more diverse populations.
• Access to Care: Partnering with community-based organizations, physicians, and long-term care organizations to improve representation in clinical research by bringing research infrastructure, personnel, and opportunities closer to underserved and special patient populations.
• Walgreens: Serves patients through a nationwide network of local pharmacies and is one of BARDA's first partnerships with a retail pharmacy, providing access to diverse patient populations and clinical locations.

The goal of these partnerships is to initially build internal capacity with BARDA to enhance decentralized care and clinical research and provide access to such DCT sites to evaluate medical countermeasures during and outside of a public health emergency. Partners will be provided with individual opportunities to rapidly expand their decentralized services (e.g., sites, virtual recruitment/enrollment, monitoring across the supply chain) to improve capacity and better prepare for the use of DCTs to respond to future health threats.

Sources: BARDA, Allucent, SAM.gov, Care Access, Walgreens