Advancing Health Through Enhanced Access

The National Association of Veterans’ Research and Education Foundations (NAVREF), in collaboration with the U.S. Department of Veterans Affairs, is dedicated to providing veterans with greater access to clinical trials that promote positive outcomes and aid scientific progress toward potential cures.

By Rick Starrs, CEO, NAVREF

From Combat & Casualty Care, Spring 2020

The National Association of Veterans’ Research & Education Foundations, or NAVREF, is the national member association for the 80 VA-affiliated nonprofit research and education corporations (NPCs) that administer externally-partnered research activities for U.S. Department of Veterans Affairs (VA) medical centers. The NPCs were authorized by Congress in 1988 to provide flexible funding mechanisms for the conduct of research and education activities at VA medical centers. NAVREF’s mission is to advance the success of these NPCs in supporting veteran health through education, communication, and advocacy. One of the ways we work to fulfill our mission is by bringing more research opportunities—from the National Institutes of Health (NIH), DoD, and especially industry sponsored clinical trials–to VA hospitals and the veterans they serve.  NAVREF bridges the gap between VA and the bio-medical industry—we help VA understand the needs of pharmaceutical and biomedical firms and we help those firms navigate VA while serving as a matchmaker connecting companies with appropriate VA investigators and study sites.

The Importance of Trials Testing

Clinical trials are research studies performed with people to evaluate a medical, surgical, or behavioral intervention. They are the primary way that researchers, clinicians and regulators find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment, if one is available. Some people join a clinical trial because the treatments they have tried for their health problem have not been as effective or had side effects that offset any benefits. Others participate because there is no treatment for their health problem. By being part of a clinical trial, participants may find out about new treatments before they are widely available.

Veterans are an underserved population for industry-sponsored clinical studies. We’ve learned from our industry partners that less than 2% of pharma-sponsored clinical trials conducted in the U.S. include VA hospitals. Unlike its intramural research program, VA never established a coordinated, standardized, enterprise-wide system for conducting externally-sponsored research.   The variation, inefficiency, and unpredictability from site-to-site deterred study sponsors from engaging VA. Furthermore, clinical trials are rarely designed to consider a population of veterans who often have multiple co-morbidities or other conditions that would exclude them from participation. Recognizing these challenges, the VA’s Chief Research and Development Officer (CRADO), Dr. Rachel Ramoni, designated “enhanced access to clinical trials” as one of her top 3 strategic priorities in late 2017 and partnered with NAVREF to kick-off the Access to Clinical Trials for Veterans (ACT for Veterans) initiative in April 2018.

Ensuring Stakeholder Support

Many stakeholders are required to make this innovative initiative succeed. VA is the largest integrated health care system in the country and the drug development process is incredibly complex. At the heart of the initiative is the veteran to whom we are trying to deliver improved healthcare. Next are VA investigators and research administrators working at VA medical centers and their affiliated NPCs, hospital leaders at those medical centers, and leaders at VA Central Office including the VA’s Office of Research & Development (ORD). Key players outside of VA include the pharmaceutical companies, contract research organizations, research sponsors, and patient advocacy groups. NAVREF works closely with all these players, in and out of government, in pursuit of improved access to clinical trials for veterans.

Addressing Critical Hurdles

The biggest challenges for this bold initiative involve changing the mind-set, getting buy-in from all stakeholders, and securing the required resources. VA built a very successful intramural research program that has earned Nobel Prizes, Lasker Awards, and ISO 9000 certifications. But research collaborations with industry partners have been infrequent and peripheral to the operation of the intramural program. Developing a centrally-resourced, standardized extramural research process is a new approach that will require a different way of thinking within VA about external partners. Directors and researchers must be willing to adopt centralized guidance and practices to improve system-wide efficiency. Pharmaceutical companies will need to reconsider their preconceptions about working with VA and be open to new opportunities. They may also want to consider how they interact with a truly national healthcare system. Together, VA and NAVREF need to find and secure the resources to establish the framework for long-term success.

Partnering for Results Achievement

Two years into the ACT for Veterans initiative, VA and NAVREF have made great strides in designing a streamlined process to initiate externally sponsored studies at VA medical centers. Most recently, VA in conjunction with NAVREF established a partnered studies program within ORD to serve as the single, national entry point and information clearinghouse for industry-sponsored studies—essentially a one-stop shop to facilitate study start-up. This program will not become fully functional until 2021, but it represents a paradigm shift in how VA supports extramural research. The CRADO also established a goal of “100 days faster” to start up clinical trials. In order to help meet this goal, VA has expanded its Central Institutional Review Board (IRB) capacity from one panel to two panels and initiated policy changes that allow for use of commercial IRBs in certain situations. Additionally, a Research Support Division within the Office of Information Technology was established in 2018 to reduce the time for review of information security requirements and improve consistency of review across VA sites. Furthermore, VA has been designing a standardized, efficient clinical trial process map that will lead to greater predictability and reliability, as requested by clinical trial sponsors.

Industry partnerships and collaboration has also been critical to the ACT initiative. We sought industry perspective to identify shortfalls and obstacles to working with VA and we continue to seek industry expertise to advise us on best practices and approaches to initiating externally sponsored clinical studies. We also seek industry resources to assist with developing the people, training, and infrastructure that will accelerate implementation of the initiative’s goals. For instance, Cohen Veterans Bioscience has supported the ACT initiative since its inception and recently elevated its commitment to become NAVREF’s exclusive “Champion Level” sponsor. We welcome contributions from any organization with an interest in improving the health of veterans.

Going Forward

Over the next 12 months, we expect to see the fruits of our labor on this initiative. We anticipate that the changes in processes, policies, and structure will reduce start-up timelines, improve predictability, and help VA become industry’s partner of choice for clinical trials. Ultimately, we’d like to see greater collaboration between VA research and the bio-medical community on veteran-focused needs. This will enable more opportunities for veterans and VA investigators to contribute to national efforts for improving the health of veterans and all Americans.

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Editor’s Note
Rick Starrs joined the National Association of Veterans’ Research and Education Foundations (NAVREF) as Chief Executive Officer in January 2016 after concluding his U.S. Army career as a Colonel. Prior to joining NAVREF, Rick enjoyed more than 25 years of leadership experience in the military health system ranging from leading troops in combat to working on Capitol Hill to overseeing the day-to-day operations of a multi-billion-dollar military medical research, acquisition, and logistics enterprise.