By Benjamin Ross

December 17, 2019 | As the clinical trial industry continues to struggle in its efforts to be more inclusive in their approach to clinical research, the National Association of Veterans’ Research and Education Foundations (NAVREF) is making its own push to include military veterans in clinical trials. Last year, the organization launched Access to Clinical Trials for Veterans (ACT for Veterans), a multi-year initiative to bring veterans enhanced access to clinical trials.

The initiative laid out several milestones for 2019, including identifying and piloting two clinical trial case studies through the established startup workflow process and finalizing a single institutional review board (IRB) process, according to NAVREF, all with the intention of initiating and conducting clinical trials efficiently within the Veterans Administration (VA).

ACT for Veterans addresses two key issues, Rick Starrs, NAVREF's CEO, tells Clinical Research News. On one hand, veterans need to be included in existing clinical research. On the other hand, clinical trials need to be geared toward veterans’ needs.

“Statistics we’ve collected from various national clinical trial organizations indicate that less than 2% of industry-sponsored trials include VA medical centers as sites,” Starrs says. “We’d like to fix that.  This is not due to a lack of interest. The VA, as the largest integrated healthcare system in the county, has a high level of interest in working with pharmaceutical sponsors and foundations to bring VA-specific trials to bear.”

Suicide, PTSD, TBI, and military exposures, among other disorders and diseases, are all targets of veteran-specific trials, according to Starrs. “These are areas where there are not a lot of research activities outside the VA and [the Department of Defense], so partnering with sponsors to find solutions in those areas is a high priority.”

The unique needs of the veteran community should also be considered during the study design.  As Starrs puts it, “Sometimes one of the hurdles to study participation is inclusion/exclusion criteria that are too restrictive, preventing veterans with comorbid conditions from participating.”

While this can leave veterans at a disadvantage, there are some clear advantages for sponsors to engage veterans at VA medical centers.  Starrs says the diversity among the veteran population is exactly what sponsors are looking for.

“A larger percentage of African Americans, for instance, are part of the VA as compared to the general study population, which is certainly beneficial for research,” Starrs says. He also notes that the percentage of women veterans is rapidly as well.

Filling the Educational Gap

The ACT for Veterans initiative includes several companies across multiple sectors within the life science industry, including Greenphire, who will be offering their standard site payment platform to make the clinical trial process more efficient for VA clinics, particularly when it comes to reimbursing patients.

Joe Gough, a Solutions Specialist at Greenphire, tells Clinical Research News their company worked extensively with NAVREF to make their ClinCard payment process technology available and as smooth and reliable as possible for veterans.

“We want to support efficiency from the study manager’s perspective, as well as provide an overall positive experience for veterans,” says Gough. “It’s also important to provide a technology that will attract additional studies once sponsors are aware an efficient participant payment infrastructure is in place within the NAVREF non-profit corporation (NPC) sites managing the studies.”

Gough says there was a great deal of communication to support and solidify the Greenphire/NAVREF partnership in the initial phases of the initiative in 2019.

“We wanted to try to offer a more centralized communication across NAVREF as a whole and not just individually,” Gough says. “We strategized ways to be able to do that, including attending [NAVREF’s] annual meeting, putting on webinars, and learning about the initiative.”

According to Starrs, this initiative addresses a key need within the VA, as they have not previously oriented internal processes to address non-VA sponsored research activities.

“The VA has a reputation within the pharmaceutical industry of being slow and somewhat unpredictable from site to site, as well as having lengthy processes,” says Starrs. “Historically, the VA has been focused on its own research program, but now it’s definitely looking to become partnered with industry sponsored efforts and in order to do so, is designing a more centralized system that is more efficient, more predictable, and more reliable.”

There’s certainly a learning curve when it comes to an initiative like ACT for Veterans. Starrs says veterans are left out of clinical research due to a lack of awareness, both from the industry and—equally important—from some internal stakeholders.

“One of the workgroups we formed as part of the initiative focused on creating a mechanism by which data could be consolidated and available, so that up front we provide more information to partners about how to work with the VA,” says Starrs. “Another big piece centers around providing more standardization and centralization to procedures when dealing with industry partners by creating a singular point of contact that will understand the enterprise-wide system and processes.”

Starrs says the goal moving forward is to ensure that veterans have equal access to clinical trial opportunities, no matter the therapeutic area.

“Having these relationships with pharmaceutical companies hopefully ensures that they see the VA as a valued partner long term, collaborating to design trials and studies that focus on the needs of the veteran population.”