Around the Globe
he US Department of Veterans Affairs (VA) is the largest integrated healthcare system in the US. VA delivers care to more than nine million enrolled Veterans at 1,255 healthcare facilities, including 170 VA medical centers and 1,074 outpatient sites of care of varying complexity. This makes the VA system a highly attractive environment for the conduct of clinical research and clinical trials, and a valuable research partner for the biopharmaceutical industry.
The size, scope, and quality of VA research is impressive:
- 79 VA-affiliated non-profit research corporations
- >60% of VA researchers also provide direct patient care
- ~70% of the country’s healthcare providers receive medical training at a VHA facility
- > 100 research sites nationwide
- >3,500 active principal investigators
- >7,000 active funded research projects
- > 10,000 published research articles each year
- ~ $2 billion annual research budget
But these numbers, as usual, only tell part of the story.
- Conducted first clinical trial in the US (1940s)
- Invented the implantable pacemaker (1950s)
- First successful liver transplant (1960s)
- Anti-hypertension medication use (1970s)
- Developed the nicotine patch (1980s)
- Discovered new diabetes drug from Gila monster venom (1990s)
- Developed Shingles vaccine (36,000 patient study) (2000s)
- Contributed development of the LUKE/DEKA advanced prosthetic arm (2010s).
The VA research enterprise includes many important resources that uniquely position VA to contribute toward the advancement of medical science. VA biomedical research capabilities across the spectrum of disciplines span pre-clinical, clinical, genetics/genomics, informatics, health services and implementation science, and its strengths as a national partner for research include:
- A full-scale national clinical research network with more than seven decades of experience;
- Largest research genetics cohort in the world;
- Dedicated research informatics and computing infrastructure that leverages VA’s national electronic health records;
- Second longest standing federal centralized Institutional Review Board, and single electronic platform for research review and approval;
- And a highly skilled and expert investigator and research staff, many of whom are leading experts with academic appointments across major US medical universities.
VA has a noteworthy history of research accomplishments and successes including three Nobel Prizes and seven Lasker Awards.
In light of all this, how does (or should) the industry partner with the VA?
Background
The US National Association of Veterans’ Research and Education Foundations (NAVREF), in collaboration with the Department of Veterans Affairs (VA) Office of Research & Development, is working to establish VA as a partner of choice for bio-pharmaceutical sponsored clinical research through the Access to Clinical Trials for Veterans (ACT for Veterans) initiative.
The first step in helping VA researchers better partner with the bio-medical industry was taken in 1988 when Congress authorized the establishment of VA-affiliated non-profit corporations (NPCs) to serve as flexible funding mechanisms in support of VA research activities. As state-incorporated 501(c)(3) research corporations, the NPCs have greater flexibility to operate and engage with non-federal entities outside the restrictions of the federal acquisition regulations.
- Enhance veterans’ access to high quality clinical trials
- Increase the substantial real-world impact of VA research
- Put VA data to work for veterans
- Actively promote diversity, equity, and inclusion within our sphere of influence
- Build community through VA research
- Precision Oncology
- Brain Health
- TBI
- PTSD
- Suicide prevention
- Military environmental exposures
- Pain management/opioid use
There are 79 NPCs across the country administering extramurally sponsored research activities for more than 3,500 VA investigators at more than one hundred research sites. These NPCs have collectively administered over $1 billion of research grants and awards, including $50-$75 million per year of industry-sponsored research, during just the past four years. However, even with this capability, pharmaceutical companies still experienced challenges in working simultaneously with many VA hospitals to conduct research in mutual areas of interest. To address these challenges, NAVREF and VA started a concerted, high-priority effort in late 2017 to Enhance Veterans’ Access to High Quality Clinical Trials.
Identifying Pain Points: Feedback from the Bio-Medical Community
In early 2018, the ACT for Veterans initiative brought VA investigators, NPC executives and VA research leaders together with pharmaceutical companies, contract research organizations (CROs) and patient advocacy groups to explore how to establish an enterprise-wide approach to external partnerships and how to facilitate policy and operations for multi-site clinical trials start-up. Historically, VA had not emphasized external partnerships and VA facilities operated more as a collection of independent entities. Therefore, despite VA being the “home” of multi-site clinical trials in the US in the 1940s, most clinical trials processes and policies assumed that the trial was already part of the VA healthcare system. In turn, besides this mistaken belief that VA was a “single entity,” industry partnerships faced many challenges in working with VA:
- Excessive study start-up time at VA hospitals, depending on experience and site infrastructure
- Lack of a single platform for coordination
- Inefficient and inconsistent processes, depending upon site and sponsor requirements
- Little incentive for centralized external partnerships approach
- Difficulties in communication with the bio-medical community, leading to misunderstanding and frustration.
Accomplishments
Based on this comprehensive industry feedback, VA started addressing gaps and building processes with a singular focus on external clinical trials. Early accomplishments included approving a new policy permitting use of commercial IRBs, implementing a new and streamlined process for centralized execution of Confidential Disclosure Agreements, and establishment of a new office—the Partnered Research Program—focused on facilitating externally sponsored research with industry partners. Through the ACT initiative, VA research is aggressively moving toward:
- Centralizing processes focused on communication and study start-up activities
- Facilitating coordinated review activities, especially Information Security and Privacy
- Enabling real-time visibility of all research activities
- Standardizing forms, templates, agreements and processes.
The ultimate goal is to get faster, more efficient, and easier to work with. These activities were done on the backbone of the fairly robust clinical research program that already existed within VA (highlighted below). Overall, these accomplishments strategically leveraged VA expertise with external/industry insights toward a shared goal of bringing more high quality clinical trials to veterans.
100 Days Faster
Encouraged by NAVREF, the Coalition to Heal Invisible Wounds and other stakeholders, VA Chief Research and Development Officer Rachel Ramoni adopted a goal of “100 days faster” for study start-up. In the middle of pursuing this goal, VA, like the rest of the clinical research community, redirected all energy and resources toward tackling the COVID-19 pandemic. VA placed a hold on non-critical, non-COVID-19 research to reduce risk for staff and veterans. However, the clinical trial improvements put in place by the ACT initiative were ready to be exercised to support COVID-19 clinical studies and accelerated with a particular focus on COVID-19. The first five extramural COVID-19 clinical trials initiated in the April/May 2020 timeframe were started by VA in an average of 12.5 days. During the following six months, extramurally sponsored COVID-19 clinical trials at VA sites administered through NPCs took an average of 30 days to get started. While conditions for starting these studies are clearly unique, these results demonstrate that it is possible for VA study start-up timelines to be competitive with academic medical centers. This is a far cry from 2018, when CROs indicated study start-up timelines at VA sites averaged more than 250 days. As clinical studies begin to expand beyond COVID-19, VA is confident that these improvements will ensure its study start-up timelines will remain competitive with those of academic medical centers.
The Way Forward
VA, NAVREF and the NPCs are continuing to pursue the priority goal of the ACT initiative, enhancing veterans’ access to high-quality clinical trials. As we adopt a continual improvement approach based on an enterprise view of opportunities and needs, these capabilities are still in relative infancy as part of the VA healthcare system. Future efforts will focus on standardizing and streamlining processes with renewed attention to improving patient recruitment and enrollment. Dr. Ramoni and her team remain committed to becoming industry’s partner of choice for clinical research.
While working closely with VA and industry stakeholders on the ACT for Veterans initiative, NAVREF recognized that communication between VA and the biomedical industry community needed to improve. Each community respectively held outdated or inaccurate perceptions of the other which inhibited their ability to work together. As a result, NAVREF is rolling out the NAVREF Industry Partner Consortium in 2021 to provide a regular and recurring forum for VA research leaders, nonprofit executives and industry partners to exchange information, share priorities, build relationships and offer insight into challenges and opportunities. Organizations interested in working more closely and collaboratively with the veteran research community should reach out to NAVREF to coordinate an introductory meeting.
VA-affiliated NPCs were authorized by Congress in 1988 to provide flexible funding mechanisms for the conduct of research and education activities at VA medical centers. As the national association of NPCs, NAVREF’s mission is to advance their success by supporting veteran health through education, communication, and advocacy.
One of the ways NAVREF works to fulfill its mission is by bringing more research opportunities—from the National Institutes of Health, Department of Defense, and especially industry-sponsored clinical trials—to VA hospitals and the veterans they serve.
NAVREF bridges the gap between VA and the biomedical industry by helping VA understand the needs of pharmaceutical and biomedical firms and by helping those firms more easily navigate VA. NAVREF serves as a matchmaker, connecting companies with interested VA investigators and study sites.