In normal times, setting up a clinical trial can take nine months or more, with the actual work going on for potentially years afterwards.
But during COVID-19, researchers don’t have the benefit of time — especially when working to find therapeutic options for vulnerable seniors in nursing homes.
*A phase-three clinical trial for a new coronavirus antibody drug from pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) is is progressing well, according to the CEO of its research partner for the project, Care Access Research. And the speed with which Care Access Research and Lilly have worked could set the standard for future investigations into drugs for the elderly and disabled into the future.
“Traditionally, research is not a option for these populations, and a lot of time, they’re forgotten,” Care Access Research CEO Ahmad Namvargolian told SNN.
That’s largely because unlike the rest of the population, nursing home residents can’t make multiple trips to the traditional trial sites of research hospitals or clinics. Instead, drug companies and their partners must take the clinic to them, which can be a time-consuming process.
Care Access Research has already had some experience with creating mobile testing sites, establishing temporary research clinics in traditionally underserved communities. Historically, each of those sites has required about two to three months of lead time, and while that’s an improvement over the typical nine-month timeframe, it still wasn’t fast enough in a pandemic.
“We thought the two- to three-month timeline, that was the limit,” Namvargolian said. “But we’ve had to challenge ourselves a little bit more.”
The firm has shortened that time to 48 hours, allowing the company to log deployments at 40 sites since first hitting the ground in late July. Teams from the company descend on participating facilities, setting up retrofitted recreational vehicles to prepare the drug, and then providing the infusions within the facility.
In addition to the wider goal of finding effective treatments for those most vulnerable to COVID-19, the nature of the trial itself requires that kind of speed: Researchers must wait for an outbreak to occur at a participating facility, then arrive quickly to test whether the drug has the intended effect of improving outcomes.
“Every full day that we can get there counts,” Namvargolian said. “Forty-eight hours is already eating away at that seven-day window, and we couldn’t wait any longer.”
The antibody, known as LY-CoV555, neutralizes a protein produced by the novel coronavirus; Lilly believes that it could be used to both treat and prevent COVID-19 infections in the nursing home setting. The drugmaker has already seen cautiously positive results from trials in hospitals and ambulatory care centers, and last week asked for Food and Drug Administration (FDA) authorization to use the antibody treatment on certain high-risk groups, the Wall Street Journal reported.
While Care Access Research isn’t involved in the eventual distribution of drugs or vaccines to nursing homes — a significant hurdle given the logistics of handling the most promising vaccines in development thus far — Namvargolian was confident about the ability to quickly send therapeutics to nursing homes as soon as they are approved for use.
“The execution of the clinical trial, clinical research, is more complicated than delivering medications that are available in the market,” he said, describing the research phase as the bigger “bottleneck” for finding effective treatments.
No matter the outcome of the Lilly trial, Namvargolian predicted that the challenges of COVID-19 will usher in a faster, more responsive era of clinical trials.
“This way of working will become the new norm of clinical research, and COVID has ben an accelerator for that,” he said. “We have been working off of strategic plans to get to this point — we thought we would be here in five years, but we’re here now.”
*An earlier version of this article gave specific timelines for the progress and completion of the clinical trial; a spokesperson for Care Access Research clarified after publication that only Lilly can determine when the trial finishes.