With COVID-19 causing unprecedented interruptions and formidable obstacles in drug development research, clinical trial sites and pharma companies often are faced with a need to get creative to continue their work. Eli Lilly and research site partner Care Access Research are doing just that with the BLAZE-2 Phase III trial of Lilly’s monoclonal antibody (mAb) LY-CoV555, a treatment the pharma firm hopes is effective in treating the COVID-19 virus.
Outsourcing-Pharma (OSP) spoke with Ahmad Namvargolian (AN), CEO and co-founder of Care Access Research, about how the pandemic and virus have impacted the company’s work, and contributions to the mobile COVID-19 study.
OSP: Please give us an overview on your work during the pandemic—how has your firm adjusted to restrictions and the demand for mobile/decentralized trials?
AN: The pandemic has brought to light and accelerated the core principles that underlie what Care Access Research is all about. The industry has talked about trial virtualization and decentralization for years. Patients across disease states – from breast cancer to Alzheimer’s Disease – have been waiting for years for research to run faster and therapies to become available sooner.
Before COVID, Care Access Research already had years of experience rapidly bringing research to people and places that would have otherwise been left out of clinical trials, such as neighborhood clinics, vulnerable populations, underserved populations, etc. The pandemic allowed us to leverage this expertise and evolve it to meet the specifications of Lilly’s trial: specifically, the ability to deploy research resources to anywhere in the country within 48 hours.
This is now a capability with existence proof; it’s something that we can continue to deploy for other COVID or non-COVID trials, and is an extension of what we have been always planned to do.
OSP: How did you come to work with Lilly—have you partnered in the past on other trials?
AN: For years, we have been deploying research capabilities, on-demand, to places where they don’t exist. Because of the nature of this trial, Lilly needed a partner that had the capabilities and experience that Care Access Research uniquely delivers and could mobilize quickly within the time constraints required by the protocol.
We had demonstrated our capability to Lilly in the past, so what needed to happen next was a natural progression: we needed to mobilize what we had, expedite the timelines, and scale it up rapidly. What resulted was that Care Access Research and Lilly took this trial from initial concept to deployment within a single month -- for comparison, it takes on average around 9 months to plan a trial.
OSP: What do we mean by “mobile trial” in this context?
AN: When we say “mobile trial”, we mean quite literally that we mobilize an entire clinical research operation – including people, equipment, software, and processes – and bring it to the patients, versus asking patients to go where research is happening. Within 24-48 hours of an indexed COVID case, traveling teams of trailer trucks, recreational vehicles (RVs), equipment, and personnel (including physicians, nurses, clinical research experts, and other medical professionals) can be deployed and operational anywhere in the country.
These teams then create temporary infusion clinics and mobile labs at participating nursing homes and assisted living facilities. And unlike virtual trials, the mobile research teams are capable of providing complex patient care and have access to a fully functioning lab.
OSP: Is this an approach/design your firm has executed in the past?
AN: While this is the first mobile clinical trial of this scale, it builds off of capabilities that we have been working on for years – especially our ability to rapidly deploy on-demand research capabilities anywhere. That capability typically takes 2-3 months to deploy, but now we deploy in 24-48 hours. This is paving the way to transforming how clinical trials are designed, how quickly they can be run, and how accessible they are to interested participants. We’re seeing this as a new way of working for everyone in the biopharmaceutical industry as a whole.
The trials of tomorrow are here now, and with our approach they can be a virtualized, decentralized, traditionally designed, or a hybrid model. This is truly revolutionary.
OSP: How does engagement with the nursing homes work—are the care centers in contact with the trial team in advance, then they contact your staff if a patient test positive?
AN: Overall, it’s a very collaborative and close partnership among Care Access Research, the facility, and Eli Lilly. In short, our team gets alerted when there is a positive case at a long-term care facility. As the COVID-positive individual is safely quarantined, our team is already on its way within 24-48 hours.
Communications are immediately activated so that we are in contact with the facility to lay the foundation needed before we show up. It is a tightly orchestrated schedule that allows us to get on the road immediately, which is critical because we only have 7 days after the alert to enroll as many patients as possible.
OSP: Is there anything else you’d like to add, about this study or other interesting projects/collaborations at Care Access Research?
AN: We’re at a turning point in our industry. With how quickly this trial has grown and scaled, we’re now at a position that we need to continually grow to meet the demand and viable locations to deploy.
If I had to share an obstacle we’re facing, it’s that we need more excellent people to join our incredible team: nurses, clinical research coordinators, patient educators, and beyond. We’re scaling quickly, across states; having more teams readily available can make or break our ability to deploy within the 48-hour time span.
Editor's note: While the US federal government this week halted its sponsored trial of the LY-CoV555 antibody, that study is unrelated to this mobile trial, which will continue as planned.