Contract research organizations (CROs) should consider partnering with the Department of Veterans Affairs (VA) when conducting clinical trials, according to an attendee at the recent Clinical Trial Collaborations conference in Boston, Massachusetts. “The atmosphere is right for increasing the number of industry-VA collaborations,” said Dawn McKenna, executive director of the Bedford VA Research Corporation in Bedford, Massachusetts. McKenna spent years working in the pharmaceutical research and development industry as well as government and nonprofit areas before taking the helm in Bedford last year.
Partnering with the VA would give CROs access to the VA system’s vast patient network; pioneering electronic health record system; patient-centric, research-oriented culture; and prodigious historical database. “We’re hoping to build more opportunities for industry to tap into our large national network,” said Grant D. Huang, MPH, Ph.D., acting director of the Cooperative Studies Program in the VA’s Office of Research and Development. This would drive advances in research as well as “allow patients access to cutting-edge care” via clinical trials within the VA system.
The VA’s goal is to double the number of clinical trials involving industry partnerships during the next two years, according to McKenna.
The VA has a history of conducting clinical trials dating back to the 1940s. The government agency was one of the leading proponents of the use of multi-site cooperative studies, which were a new paradigm at that time.
What’s more, the VA’s track record includes some highly impactful collaborations with industry. For example, the VA, in partnership with Merck, conducted a pivotal efficacy trial on the shingles vaccine Zostavax. The findings informed the Centers for Disease Control and Prevention’s recommendation of the vaccine for adults 60 years of age and older.
Still, VA leaders contend that their system’s potential to advance industry-backed research and accelerate development of new treatments is untapped. They say that the VA is in a prime position to create efficient and scalable mechanisms to perform comparative effectiveness studies, for example.
In addition, the VA’s newly established Precision Oncology Program (POP) provides an innovative framework for industry partnerships. POP is designed to enhance the enrollment of patients into clinical trials of novel targeted therapeutics; facilitate creation of a national VA database of patient characteristics and tumor mutations; and share outcome data—all with the intent of speeding the pace of discovery in cancer care.
POP is one of the VA’s contributions to the White House’s new $1 billion National Cancer Moonshot initiative. The Moonshot effort is aimed at eliminating cancer by accelerating research efforts and breaking down barriers to progress, in part, by facilitating collaborations with researchers, doctors, philanthropies, patients, patient advocates and biotechnology and pharmaceutical companies.
One of those barriers has long been navigating logistical red tape required to work with the government. “The primary impediment to partnering with the VA has been the time involved in obtaining a Cooperative Research and Development Agreement (CRADA),” said McKenna.
“Our experience has been that the VA system is cumbersome,” echoes Amy Grahn, senior vice president of Clinical Development and Operations at Horizon Pharma. Horizon is supplying the drug RAYOS (a delayed-release form of prednisone) and the placebo for the Gulf War Illness Inflammation Reduction Trial, sponsored by the Minneapolis Veterans Affairs Medical Center. “The major deterrent to getting the trial going was the time and paperwork involved in signing the CREDA,” said Grahn. The process took nearly a year—far longer than the several months it typically takes to sign off on a study carried out with an academic institution. “CROs can’t do anything until the CRADA is in place,” said Grahn.
Historically, each CRADA was painstakingly created and negotiated on a case-by-case basis. Recognizing the problem, the VA standardized its CRADA agreement in October of last year. Going forward, the change should streamline the process of getting the agreement in place and could go a long way in encouraging industry CROs to consider partnerships with the VA system.
Another problem with working within the VA system is that monitoring the progress of the study can be particularly challenging, according to Grahn. The government’s high security standards and restrictions on visit times can make it difficult for researchers to access study sites, she said.
Drawbacks aside, there are a number of advantages to partnering with the VA, including access to “one of the best electronic health systems and lots of historical data,” said Grahn.
Another advantage of working within the VA is that the military mindset of veterans’ makes them more likely to serve in trials. McKenna estimates fewer than 10% of adults with cancer take part in clinical trials, but “veterans are willing participants if they know they will help others because of their incredible sense of duty.”
In addition, the sheer number of veterans in the system increases the likelihood that researchers can identify a pool of research subjects with rare genetic mutations or orphan diseases.
“If the VA can continue to improve the logistics of the system, clinical trial partnerships would be much more attractive to industry and really a wonderful opportunity,” said Grahn.
This article was reprinted from Volume 20, Issue 13, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »