AstraZeneca has tapped decentralized research organization (DRO) Care Access Research for its Phase III trial of AZD7442 (with the moniker ‘Storm Chaser’). The therapy at the center of the study is the pharmaceutical company’s long-acting, monoclonal antibody combination for the potential prevention of COVID-19.
Ahmad Namvargolian, CEO and co-founder of Care Access Research, told Outsourcing-Pharma the Storm Chaser trial will assess the treatment’s safety and efficacy for post-exposure prophylaxis and pre-emptive treatment in an estimated 1,125 patients in the US and UK. The trial will include participants over 18 years old following exposure to the virus, as well as individuals people living or working at long-term care facilities, and those working in industrial and military settings.
“These populations are traditionally underserved, so this research is especially important to us,” he remarked.
What's more, he pointed out, there is considerable interest in discovering effective COVID-19 treatments quickly and safely.
“With COVID-19 treatment candidates like AZD7442, time is of the essence,” he said. “Traditional study designs limit who can participate in a clinical trial and how quickly the trial can be completed; with Care Access’s unique capability to rapidly deploy and manage mobile clinical research sites, the entire operations of a clinical trial can be brought to patients directly.”
According to Namvargolian, the past 12 months have been ‘transformational’ for the company, thanks to the challenges created by pandemic stay-at-home mandates and overworked medical facilities putting decentralized trial specialists like Care Access Research center stage.
“For years, Care Access Research has been deploying research capabilities, on-demand, to places where they don’t exist,” he commented. “With the intense urgency to develop vaccines and treatments for COVID-19, there was a wave of attention brought to the decentralized model, as it has great benefits for reaching underserved populations, including seniors, factory workers, and those in other industrial settings.”
The Care Access Research model uses its Mobile Sites On Demand model, which deploys personnel, trucks, equipment and supplies to strategic locations.
“Decentralized trials help underrepresented populations participate in clinical research and get access to care and treatments they might not have been able to get due to their location or personal health situations,” Namvargolian said. “We can come right to the patient where they live or work.”
The Storm Chaser project received federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
In addition to this partnership with AstraZeneca, Namvargolian said, the firm also worked with Eli Lilly on a decentralized trial of its LY-CoV555. The effort included deploying teams of and gear to nursing homes across the US for the study.