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 novel partners to build sustainable and accessible decentralized clinical trials (DCTs), allowing for rapid and flexible clinical validation of novel technologies and approaches for pandemic preparedness. These five-year partnerships are a significant step towards fostering innovative DCT capabilities.
Nearly 80% of trials fail to meet their enrollment goals in the stated timeframes, often contributing to billions of dollars in delays annually. With only 5% of the U.S. population participating in clinical trials, there is a clear need to increase access and representation in clinical research.
The COVID-19 pandemic further catalyzed utilization of decentralized healthcare, including telemedicine, retail clinics, wellness apps, and more. At the same time, the pandemic highlighted the need for clinical trial modernization – specifically, the need to shift from traditional, centralized clinical studies to more patient-centric, decentralized clinical research that enables participation from more locations in order to rapidly validate and distribute broad sets of medical countermeasures (MCMs) including new diagnostics, vaccines and antivirals.
BARDA’s first three D-COHRe strategic partners are:
- Allucent: Offers DCT trial capabilities including diverse site models, data collection, electronic clinical trial technological capabilities, and DCT expertise, to improve patient-centricity and increase access to more diverse populations.
- Care Access: Partners with community-based organizations, physicians, and long-term care organizations to improve representation in clinical research by bringing research infrastructure, staff, and opportunities closer to underserved and special patient populations.
- Walgreens: Delivers care to patients through a national community pharmacy network, providing access to diverse patient populations and clinical sites as one of BARDA’s first partnerships with a retail pharmacy.
The goal through these partnerships is to initially build internal capability to enhance decentralized care and clinical research jointly with BARDA and to allow for access to such DCT sites in order to assess medical countermeasures, during and outside a public health emergency. Partners will have individual opportunities to rapidly expand their decentralized services (i.e., sites, virtual recruitment/enrollment, monitoring along continuum of care) to enhance capabilities and better prepare for use of DCTs to respond to future health threats.
Sources: BARDA, Allucent, SAM.gov, Care Access, Walgreens