1. DiGiulio, Sarah

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The NCI and the Department of Veterans Affairs (VA) recently announced an agreement that outlines specific ways the agencies will collaborate to boost veterans' access to cancer clinical trials.

Sheila Prindiville, ... - Click to enlarge in new windowSheila Prindiville, MD, MPH. Sheila Prindiville, MD, MPH

The initiative is called NAVIGATE, which stands for the NCI and VA Interagency Group to Accelerate Trials Enrollment. And a key facet of the agreement is that NCI will provide more infrastructure to help the VA better participate in NCI-sponsored trials.


NAVIGATE will also allow for more VA investigators to be involved in clinical cancer research and provide more opportunities for these investigators to determine what research is needed, including ones of particular importance to veterans with cancer.


"This agreement will not only provide veterans greater access to NCI clinical trials, it will enhance accrual to NCTN [National Clinical Trials Network] and NCORP [NCI Community Oncology Research Program] trials, resulting in more timely completion of these studies. This interagency collaboration will also work to help veterans overcome barriers they've faced trying to access clinical trials as part of their cancer care," noted James H. Doroshow, MD, NCI's Deputy Director for Clinical and Translational Research, in a press release.


In the recent agreement, NCI and the VA agreed to jointly manage the new program for up to 3 years. The participating sites are expected to establish best practices and share insights as they go to help other VA sites nationwide initiate new research and increase veteran enrollment in cancer clinical trials.


In an interview with Oncology Times, Sheila Prindiville, MD, MPH, Director of the Coordinating Center for Clinical Trials at NCI, explained more about the goals and specifics of the program.


1 What is NAVIGATE and how will it change how NCI and the VA work together on cancer clinical trials?

"NAVIGATE is a partnership between NCI and the VA to make it easier for veterans to access state-of-the-art treatments through NCI-supported clinical trials directly at VA sites, rather than seeking treatment outside of the Veterans Health Administration.


"It's a 3-year collaboration between NCI and the VA to facilitate enrollment of veterans into NCI-funded clinical trials. It's also an opportunity for government agencies long committed to veterans' health to partner at the national level to make clinical trials more accessible. This strategic partnership was prompted by the observation that fewer veterans were participating in NCI-supported clinical trials than in the past. One of the reasons identified was the lack of infrastructure support for dedicated clinical research staff.


"NAVIGATE is a win-win initiative. It will make it easier for veterans with cancer to receive the newest treatments and increase their participation in NCI-supported clinical trials. The increased participation should allow the trials to be completed more quickly and new treatments to become available sooner."


2 But the VA had already been conducting clinical trials in cancer. Can you explain how the agency had been collaborating with NCI, if at all?

"The VA offers clinical trials in many disease sites, including cancer. Historically, the VA had a role in the establishment of multisite clinical trials for evidence-based practice starting in the 1940s. The [agency] conducts cancer clinical trials sponsored by the NCI, as well as [trials sponsored by] other organizations such as industry, academia, and other partners. The VA will continue to conduct trials with these partners, including NCI, as it has done in the past.


"What is new is that NCI is providing funding to the VA through NAVIGATE so that sites have support for dedicated research coordinators specifically for NCI-funded trials. Additionally, the program will utilize a centralized approach coordinated by the VA Cooperative Studies Program to address site-level and system-wide challenges to trial activation and enrollment."


3 Can you share any specifics about how NAVIGATE is being rolled out?

"Twelve VA sites are participating in the program and will receive funding for dedicated clinical research staff to assist with the conduct of clinical trials. At each site, a VA principal investigator will oversee the NAVIGATE activities.


"The VA Cooperative Studies Program, Office of Research & Development, and the NCI Coordinating Center for Clinical Trials will provide coordination and management for NAVIGATE.


"A steering committee consisting of VA and NCI staff will use a centralized approach to address system-wide and site-level challenges to trial activation and enrollment.


"An executive committee consisting of NCI, VA, and NCTN senior leadership will monitor the overall progress and direction towards meeting the NAVIGATE program goals."