Stanford ValleyCare Launches First Clinical Trial
A Research Milestone in the Midst of a Pandemic
Setting up a large-scale clinical trial is a complicated endeavor. A team of researchers needs to be assembled, patients need to be recruited, sites need to be set up. It’s a process that can take months.
But as it happened, Stanford ValleyCare’s first-ever clinical trial ended up being a rapidly-approved ongoing adaptive trial during the COVID-19 pandemic. In a matter of weeks, the people of Stanford Valley Care, from staff to faculty, from the lab to the boardroom, organized and implemented their first trial, with impressive results.
Stanford ValleyCare is one of 69 trial sites for the NIH ACTT trial, or Adaptable Covid-19 Treatment Trial, which began Phase 1 with explorations of the effectiveness of remdesivir and is now moving on to Phase 2, where another drug, baricitinib, will be tested. The significance of remdesivir’s effectiveness is all over the news, but the significance for ValleyCare and its community is also a “bright spot” in the midst of the pandemic, as David Svec, MD, MBA, clinical associate professor of medicine and Chief Medical Officer at ValleyCare explains.
Stanford Healthcare - ValleyCare is the result of a merger between ValleyCare, a 167-bed hospital serving the Tri-Valley region of California (the area surrounding the Amador, Livermore, and San Ramon valleys) and surrounding communities, and Stanford Healthcare in 2015. Stanford School of Medicine faculty, who are now practicing in the Tri-Valley, hoped to get clinical trials and other research projects started there as part of a larger 5 year long strategic planning initiative, and the pandemic supercharged their efforts. As Evelyn Ling, MD, MS, clinical assistant professor of medicine and ValleyCare physician research co-champion says, “This trial represents the fusion of the Stanford mission, bringing the kind of research that's typically only at academic centers to a community center, but still being able to use our local nurses, pharmacists and lab. It’s a really meaningful first trial.”
And trials at Stanford ValleyCare benefit not only local patients but also the larger Stanford community: “I think there's extreme excitement to be able to offer clinical trials in the Tri-alley,” Svec says. With a second hospital, Stanford’s now able to do multi-center side studies within its own network, benefiting “multiple counties in a more patient-friendly manner.”
As physician research champions, both Evelyn Ling and Minjoung Go, MD, clinical assistant professor of medicine, were leaders on the ground at Stanford ValleyCare, although this was the first clinical trial that either of them had taken such a large part in.
"I think it's amazing how everyone came together.
This particular trial came together with lightning speed. The process of setting up an infrastructure for clinical trials, slow-moving and deeply complicated under normal circumstances, was accelerated with the outbreak of COVID-19. In late March the possibility of an NIH trial at ValleyCare arose, and the first ValleyCare patient enrolled on April 9.
As of May, the second phase of the trial was already beginning, with promising results from the first phase published and released to the public.
Naturally, this intense timeframe put a great deal of pressure on everyone at Stanford ValleyCare, from the physicians to the staff to the lab workers. When the trial began, there was no real infrastructure for clinical trials.
But by all accounts, all the various teams, from the lab to the pharmacy to the phlebotomists and the doctors and nurses, were supportive and excited by the possibilities of the trial. Go described the process as “challenging” but also relatively “seamless."
“I was on the night shift, so trying to attend all the daily meetings was a little bit challenging,” she admits. “It felt a little like trying to fly a plane while you’re building it. But it was a really, really rewarding experience. I got to learn a lot of the process of clinical trials and how to operationalize them.”
Ling agrees: “I think it's amazing how everyone came together. Everybody's very excited about being part of these COVID-19 trials, too. There's just this added layer of investment and excitement.”
Part of the excitement was also fostered by a built-in sense of community. “As a smaller hospital, we’re like a family,” Go says. “A lot of people have been working here for many years, and we have very close communication and contact with many different departments. Everyone here is supportive and dedicated. I'm very grateful and fortunate to be part of it.”
Svec and others were also quick to praise the support of everyone not just at ValleyCare but also at the Palo Alto site of the trial, including PI Neera Ahuja, MD , MD, clinical professor of medicine and Hospital Medicine division chief, and senior director of clinical research in hospital medicine Kari Nadeau, MD, PhD.
As for the future? Stanford ValleyCare is involved in some upcoming COVID-19 trials, and they’re even thinking about trials in the post-COVID-19 timeline. Ling explains, “A lot of people think they have to go all the way out to Palo Alto or UCSF to get clinical trials, so it's nice that we're now able to offer this to our patients here.”
Clearly, Stanford ValleyCare took the trial and its coordination and all the logistical complications in stride. What’s more, they were happy to do it. As Ling says, “We're just really excited to be able to offer this to our community.”