Clinical trials are the gold standard for evidence-based medicine and practice. They enable clinicians, patients, and policymakers to know whether new treatments are effective and safe and which options among existing therapies may be better in different situations. VA Research has a robust program of clinical trials, including a quality-certified clinical research program embedded within VA’s health care system and partnerships with industry, other federal agencies, and foundations.

These partnered trials provide additional opportunities for Veterans and VA clinicians to participate in important studies that advance health outcomes for Veterans and the nation. Increasing Veterans’ access to clinical trials gives Veterans more options to receive promising new treatments in a highly regulated environment, while also enabling them to continue to serve the nation through their voluntary participation in research.

To increase access to high-quality clinical trials, VA Research is undertaking a set of major coordinated activities. These activities make up the Access to Clinical Trials (ACT) for Veterans initiative. The National Association of Veterans Research and Education Foundations (NAVREF) plays a key role in these efforts.

ACT for Veterans leverages existing infrastructure and expertise that VA has maintained as a leader in the national clinical research enterprise. The initiative also provides Veterans with more opportunities to participate in partnered multisite clinical trials and improve how clinical trials are conducted within VA.

ACT for Veterans activities include the following:

• The development of efficient processes for enabling externally partnered clinical trials within VA to get up and running more rapidly. The aim is stronger coordination among stakeholders, including VA clinicians, program offices, administrators, industry, VA nonprofit corporations, and patient advocacy groups.
• Promotion of the National Cancer Institute (NCI) and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE) to provide Veterans greater access to cancer clinical trials, which are often considered an essential part of optimal cancer care. This partnership with the NCI will serve as a model for other federally partnered research.
• Continued development of VA’s clinical trials infrastructure to produce innovative approaches in Veteran recruitment, the use of informatics and analytic tools, and quality assurance.

These efforts will enhance and expand VA’s ability to conduct clinical trials with external partners and capitalize on the department’s unique role as the nation’s largest integrated health care system.

Before research can be effectively translated into real-world practice, innovations generated by researchers require additional development, validation, and implementation. This ensures that all Veterans can benefit from the outcomes of research discoveries. Notably, advances in genomics and other areas of basic science have accelerated the rate of development of new therapies in animal models. These advances, in turn, will inform new clinical treatments for Veterans.

Advances in technology can lead to the development of new devices that improve Veterans’ ability to function and their quality of life. VA is also at the forefront of creating new models of care to help frontline providers enhance access to effective innovations and treatments, notably through telemedicine, mobile technology, and electronic health record innovations that promote Veteran-centered care.

Before any such treatment or care models can benefit Veterans, however, their effectiveness and feasibility in real-world settings must be evaluated.

VA Research aims to ensure that Veterans benefit in tangible ways from advances across the spectrum of VA research, including genomics and the basic sciences; rehabilitation and technology; and clinical and implementation science studies. Key activities in this area including the following:

• VA’s Technology Transfer Program: TTP facilitates the commercialization of VA inventions to benefit Veterans and other Americans. As of 2020, VA Research is undertaking the following activities to strengthen TTP’s role:
  • Partnering with the U.S. Department of Commerce’s National Technical Information Service to apply data-science methods that will strengthen TTP’s capability for patenting and licensing inventions resulting from VA-funded research. This will ensure VA collects the investment returns it is entitled to and help provide better products and services to Veterans.
  • Initiating the Technology Transfer Assistance Project to help VA researchers turn technological advancements into devices and products that can be evaluated and deployed to benefit Veterans.

• Translation of Basic Science Findings: In 2020, VA Research is increasing support for initiatives that facilitate the translation of research discoveries to human trials of new treatments shown effective in small animals through the following activities:
  • Increasing the number of licensing agreements that allow private industry to support required studies.
  • Increasing the use of interagency partnerships through matching investigators to existing programs in other agencies.
  • Encouraging and supporting stronger networking among groups of VA investigators conducting related research and funding translational Merit Awards to help move discoveries from bench to bedside.

• Implementation science to promote uptake of effective innovations by frontline providers: Implementation science is the study of methods that help increase the use of evidence-based treatments in real-world practice. In VA, the goal is to ultimately improve access and effectiveness of treatments among Veterans.
  
  Implementation research develops, refines, and test strategies that support health care providers in the adoption or adaptation of evidence-based practices (or in some cases, the de-implementation of low-value practices). This approach is especially valuable in addressing organizational constraints such as limited resources. VA Research has been a national leader of this emerging science, notably through its Health Services Research and Development Service.
  
  VA Research is investing in implementation research that benefits Veterans through the following programs:
  • VA Cooperative Studies Program (CSP) implementation programs: These programs help ensure that interventions that are currently being tested in clinical trials are developed and deployed for real-world use. This involves conducting empirical research on the implementation process of treatments tested in the clinical trials, and developing strategies to further deploy treatment shown effective, including handoffs to VA national leaders, providers, and other stakeholders.
  • Health Services Research and Development implementation research initiatives. HSR&D investigators are working to (1) capitalize on multilevel partnerships across VA, Veterans, and caregivers; (2) leverage current knowledge of treatment interventions and implementation strategies addressing major health risks and disabilities facing Veterans across the U.S.; (3) identify barriers and facilitators; (4) develop and maintain partnerships that will drive intervention uptake and long-term sustainability; and (5) enhance research capacities to improve health outcomes for Veterans at high risk of poor outcomes.

• Translational Science Initiatives: VA Research is investing in translational science initiatives that lead to a more substantial real-world impact. These efforts will fill gaps in the VA Research translational pipeline, foster crucial linkages to real-world practices to disseminate and implement research, and support VA efforts to develop a health care workforce that uses research findings in day-to-day practice. Increased emphasis will be placed on support for the studies needed to obtain FDA authorization for human trials, and on the funding of phase 1, 2, and 3 clinical trials.

VA aims to accelerate scientific discovery by reducing the time and effort needed to appropriately access, properly understand, and effectively use Veteran data for improving Veterans’ well-being. VA’s investment in health information technology and scientific discovery is coupled with its status as the largest provider of health care and mental health services in the nation. This enables the department to develop some of the most comprehensive and complex medical data in the world, including diagnoses, medication information, procedures, and test results. Much of this information has been linked to the MVP mega-biobank and to other clinical projects that include both genomic and patient-reported information.

These data resources create possibilities for unparalleled scientific discovery. Maximizing the potential of the data will require key activities in data preparation, infrastructure modernization, strategic partnerships, and dissemination, as detailed below.

As of 2020, VA Research is undertaking the following activities, among others, in support of this strategic priority. In all activities, rigorous safeguards are in place to ensure the privacy and confidentiality of Veteran data. Depending on the project, these may include, for example, the use of firewalls, encryption, and de-identification of data.

• Increasing recruitment of VA patients into clinical studies and expanding recruitment to include Veterans who are not currently using the VA health care system.
• Collecting biospecimens for genomic analysis and investing in next-generation genomic data sequencing.
• Partnering with other federal agencies, including the Department of Defense and Health and Human Services, as well as with community health care systems to link health, demographic, and environmental data.
• Curating and standardizing linked data sources so they can be analyzed together seamlessly.
• Establishing and maintaining a centralized VA Phenotype Library of all curated phenotypes and their associated metadata for use by all VA researchers and eventually the research community at large.
• Supporting the interaction of new medical data with historic VA data as the department transitions to its new electronic medical record system.