On Aug. 3, TrialSite applauded the effort of Lilly & Co. (NYSE: LLY) and the National Institute of Allergy and Infectious Diseases (NIAID) for the Blaze-2 clinical trial. Why? Because it’s one of the first, if not the first nationwide intervention during the COVID-19 pandemic to help save elderly residents in long-term care facilities (LTC). The residents at these facilities have experienced horrific and unacceptable death rates. In this pivotal Phase 3 clinical trial, Lilly and partner NIAID mobilize a fleet of customized mobile units to support LTC facilities around the nation to treat elderly with the very promising monoclonal antibody product LY-CoV555 (again developed thanks to a partnership with AbCellera, NIAID and dedicated Lilly scientists). Care Access Research, a partner in this critically important endeavor, recently shared some updates on this study and its importance to the elderly, long term care facilities during the pandemic.
Recently updated by Alex Spanko writing for Skilled Nursing News, Lilly has helped transform the paradigm of how to reach the elderly in a pandemic. Traditional research procedures wouldn’t allow for the elderly to participate in such a clinical trial but, of course, the COVID-19 pandemic has turned everything upside down.
Research in the LTC Environment
As Mr. Spanko reminds all that, traditionally, executing a clinical trial is a lengthy, comprehensive process that doesn’t help with a pandemic where help is required immediately. When Lilly embarked down the path of Blaze-2, it required a whole different model.
Enter Care Access Research
TrialSite updated the network on Oct. 1 on the Lilly and Care Access Research partnership. Lilly partnered with this emerging leader in the set up and mobilization of high-performing research sites to manage this first-of-its-kind system of decentralized, mobile clinical COVID-19 trials for Blaze-2.
Trials On the Move
In a conversation with Skilled Nursing News, Care Access Research CEO Ahmad Namvargolian shared that in a traditional sense residents in LTCs (e.g. nursing homes) can’t easily participate in research. Its not practical for elderly residents to make multiple trips to site locations, for example. Rather, the drug companies (sponsors) must bring the clinic to them and this is where the Lilly and NIAID model is commendable.
And that’s why Lilly partnered with Care Access Research, as this firm’s model is exactly able to support these flexible and dynamic trial site scenarios. In the case of Blaze-2 the firm has to actually mobilize and distribute the mobile testing clinics to traditionally underserved communities, e.g. LTCs, or even rural or inner-city African American districts, Hispanic barrios and Native American tribal lands for example.
In the typical study scenario, Mr. Namvargolian told Skilled Nursing News that each individual trial site could require two to three months of lead time. Of course, this is not acceptable in a pandemic where the elderly are dying at appalling rates. Something had to be done much sooner. Namvargolian emphasized, “We thought two-to-three-month timeline, that was the limit.” And continued, “But we’ve had to challenge ourselves a little bit more.”
A New Precedent
And did Mr. Namvargolian and team come up with a solution. They condensed that duration to 48 hours, logging 40 deployments at 40 sites since initiation in late July, reports Alex Spanko. In an organized and orchestrated manner, the Care Access Research team would “descend on participating facilities, setting up retrofitted recreational vehicles to prepare the drug, and then providing the infusions within the facility.”
Just in Time Trial Site
Moreover, the nature of this pandemic and LTCs make it critically important to treat the outbreak as it occurs. With units scattered across the United States, the Lilly and Care Access Research team await outbreak news and immediately move into position, arriving at the participating facility to execute the trial—e.g. infusions of the LY-CoV555 investigational therapy.
The Study Therapy
TrialSite discussed the beginnings of this powerful investigational therapy: one that competes with the Regeneron product (REGN-COV2) recently taken by POTUS. The discovery of this potential therapy required intensive and impressive collaboration between a University of British Columbia (UBC) spinoff, AbCellera, NAID’s vaccine center and what TrialSite refers to as smart and dedicated, 24×7 cranking Lilly scientists.
This monoclonal antibody neutralizes the protein produced by SARS-CoV-2 and Lilly recently submitted for emergency use authorization along with Regeneron.
A New Norm
The Care Access Research CEO predicts that COVID-19 has changed clinical trials forever. The precedent or bar has been set as “…COVID-19 will usher in a faster, more responsive era of clinical trials.” Namvargolian informed, “This way of working will become the new norm of clinical research, and COVID has been an accelerator for that.”
Research as Care
TrialSite suggests the era of the nascent clinical research as a care option movement is just beginning as COVID-19 ushers in a new sense of imminence, direction and purpose for directed health care. With ubiquitous cloud computing, apps and devices and the budding digital health movement, clinical trials become more embedded and integrated into health systems. TrialSite will sponsor an imminent conference discussing the topic