“VA research is embedded in the largest integrated health care system in the country,” said Dr. Rachel Ramoni, VA’s chief research and development officer. “We’re in a position to do things that no one else in the world can do to improve the health of our Veterans, the country, and the world.”
Since assuming her role in 2017, Ramoni has made it a top priority to increase Veterans’ access to clinical trials.
With the advent of the COVID-19 pandemic, her office convened a response team that huddles daily to identify and advance research opportunities for VA investigators nationwide. They work closely with a steering committee of VA experts in virology, infectious disease, and epidemiology. That group has been doing expedited reviews of incoming ideas and proposals from VA investigators to identify the most viable and promising studies to fund.
`Desperately needed knowledge’
One focus of the response team has been linking with the pharmaceutical industry. This happens through legal arrangements known as “cooperative research and development agreements.” The agreements allow VA to partner with companies to test promising drugs or medical devices with Veteran study volunteers.
Now these public-private contracts are especially crucial. Drug companies with promising vaccines or treatments for COVID-19 need to urgently get their products into clinical trials.
“Together, VA and industry can rapidly generate desperately needed knowledge for the prevention and treatment of COVID-19,” Ramoni said.
In past years, regulatory hurdles were more cumbersome—in some cases, prohibitive. Because of this, many companies were deterred from partnering with VA to test new treatments.
Nationwide scale a huge asset for research and Veterans
Under Ramoni’s leadership, that landscape has shifted. VA has made a concerted effort since 2018, in the framework of an initiative called Access to Clinical Trials (ACT) for Veterans, to educate potential partners—from industry as well as the federal sector—and break down barriers to collaboration.
VA is now a far more attractive partner for industry. The organization has a nationwide cadre of experienced investigators. Other assets include a tested clinical trial infrastructure ready to move quickly, and a large pool of potentially eligible Veterans study participants who are motivated to serve once again to help their fellow Vets and other Americans.
“We want to become the partner of choice for industry,” Ramoni said.
That’s true for COVID-19 and for other conditions, like cancer.
Ramoni points out that in the past, the average time it took to start up an industry-sponsored trial in VA was 285 days, nearly 10 months. In comparison, academic medical centers were doing it in around five months. Her office has committed to cut the VA average to about six months by October 2021, “to even the playing field.”
That’s all during normal times. During the COVID-19 pandemic, as noted above, VA is finding ways to slash the time frame more dramatically.
“A lot of what we’ve been working on is rolling out more standardized, streamlined approaches,” says Ramoni.
She envisions companies and other collaborators partnering with VA to quickly stand up their trials at numerous VA medical centers at once—at least five or so at a time.
“It takes virtually the same time to set up a trial for 20 sites as for one site,” she notes.
The nationwide scale of VA, which in the past has been part of the difficulty in organizing large trials, can be a huge research asset nowadays, given the newer infrastructure, she says.
That stands to help lots of Veterans who are coping not only with COVID-19, but with many other health conditions.
This VAntage Point was updated on May 15, 2020.
Mary Kelleher, with VA’s Office of Research and Development, contributed to this article.