Agencies join forces to boost the number of veterans in cancer clinical trials: A new program is helping to make National Cancer Institute-sponsored trials more accessible to a vulnerable population.

Abstract

A new initiative by the National Cancer Institute (NCI) and the United States Department of Veterans Affairs (VA) aims to increase the number of veterans who enroll in NCI-sponsored cancer clinical trials and gain access to promising treatments. Moreover, officials hope the program will set off a chain reaction by establishing best practices that may spread to nonparticipating sites and bolster cancer care in general. The program, known as the NCI and VA Interagency Group to Accelerate Trials Enrollment, or NAVIGATE, launched last fall at 12 VA facilities nationwide and will continue for up to 3 years. As part of the effort, the NCI will provide sites with $150,000 annually to support the staffing and resources needed to conduct or participate in NCI- sponsored cancer clinical trials. Although the VA manages a clinical research program of its own, with clinical trials for cancer and other diseases at more than 100 sites across the country, it often faces challenges in initiating and completing the studies, according to officials. Among other things, VA staff have lacked adequate support for performing the regulatory and administrative tasks required. Apart from extra staff, NAVIGATE sites also have access to a coordinating center located at the VA Boston Healthcare System in Boston, Massachusetts. It has been set up to provide additional assistance, troubleshoot problems, and ensure communication and the exchange of information between facilities in the program. For many participating facilities, the open dialogue facilitated by this office has turned out to be crucial. “We have this nice resource where we can talk to people about things like the Lung-MAP trial or information security, and that has been a huge help in knowing who to contact quickly,” says Alicia Roy, a research health science specialist for the VA Connecticut Healthcare System in West Haven, Connecticut. NCI and VA leaders also are heavily involved in overseeing and guiding NAVIGATE through both an executive leadership committee and a steering committee. Altogether, NAVIGATE “is creating a model partnership between the NCI and VA,” says Grant Huang, MPH, PhD, director of the VA Cooperative Studies Program, a division of the VA Office of Research and Development, and a steering committee co-chair. “It offers a new approach to dealing with common challenges on a more national level by utilizing the resources and expertise of these 2 agencies.” The idea for the program first arose in the summer of 2016, after officials from both agencies noted that fewer veterans were enrolling in NCI- sponsored clinical trials than in the past. “There’s a need to reinvigorate the priority of cancer clinical trials as a standard-of-care option for veterans with cancer,” Huang explains. Indeed, according to Sheila Prindiville, MD, MPH, director of the NCI Coordinating Center for Clinical Trials and a fellow steering committee co -chair, some 45,000 new cancers are diagnosed annually at the VA, with the most common being prostate, lung, and colorectal cancers. However, non-veterans with cancer may benefit from the program, too. NAVIGATE, Dr. Prindiville adds, offers a win-win situation. “We’re helping the VA build an infrastructure with dedicated research staff to support clinical trials while also helping NCI increase clinical trial accrual rates so we can complete them more quickly and get new treatments out sooner,” she says. For example, the additional resources may help VA leaders move forward with plans to conduct clinical trials in which patients are assigned to receive treatment based on the genetic profiles of their tumors. They have already launched a national precision oncology program that has enabled VA clinicians to order genetic testing of tumor samples. The next step will be matching that information with potential clinical trials, says Rachel Ramoni, DMD, ScD, the chief research and development officer for the VA. The NCI and VA have had recent success in partnering to improve patient outcomes. Dr. Ramoni points to the Big Data-Scientist Training Enhancement Program (BD-STEP), an initiative shared by the 2 agencies that brings early career data scientists into the VA to focus on oncology. The program supports postdoctoral fellows with physical science and engineering backgrounds, as well as those with computational expertise, who are matched with VA medical centers. Although the agencies plan to manage the program for up to 3 years, officials ultimately view NAVIGATE as a tool for creating a sustainable cancer clinical trials infrastructure for the VA that will continue for years to come. For instance, by encouraging the 12 sites to operate as a network, “we’re looking for the NCI funding to catalyze a change in how we do business and operate as a system when we do clinical trials,” Dr. Ramoni says. Moreover, Dr. Huang adds, the NAVIGATE network will be developing best practices, tools, and techniques that “will be seen as an attractive component to future NCI, industry, and other trial funding agencies or groups.” “There’s a need to reinvigorate the priority of cancer clinical trials as a standard-of-care option for veterans with cancer.” —Grant Huang, MPH, PhD “If we can track how many veterans we screen for clinical trials and how many were excluded for comorbidities, we can give the NCI feedback about future clinical trial design that might reduce some of those exclusions,” says Herta Chao, MD, PhD, an oncologist and clinical trials investigator at the VA Connecticut Healthcare System. Researchers are not alone in their optimism about the program. One encouraging sign that has emerged, officials say, is that patients who participate in NAVIGATE are among its best advocates. In 2018, with help from the NAVIGATE grant, the VA Connecticut Healthcare System enrolled nearly 250 patients in cancer clinical trials, compared with fewer than 25 patients in 2013. Dr. Chao attributes some of that to word of mouth: as the number of veterans enrolling in clinical trials at the hospital has increased, Dr. Chao notes that word is spreading. Indeed, says Jessica Jordan, a research health science specialist for the VA Connecticut Healthcare System, “the more clinical trials we get in, the more patients talk about it and ask when they can be put on one.”