Most Involve Potential Therapeutic Agents
By Annette M. Boyle
WEST HAVEN, CT—The number of clinical trials open to veterans with cancer in the New England region (VISN 1) grows every week, leading a return to the prominence the VA had in trial programs in decades past and offering veterans access to the “gold standard” of treatment in oncology.
“If you go back several years, the VA was very active in clinical oncology trials, but new regulations led to a shift that made it more cumbersome to do trials in the VA system, and they petered off,” explained Michal Rose, MD, director of clinical cancer trials for VISN 1. “Quality studies showed that the VA gave at least as good care as community health organizations, but with less enrollment in clinical trials and a boom in new medications, it was clear that if we didn’t find a way to participate in more trials, veterans would lose out.”
About five years ago, Michael Mayo-Smith, MD, MPH, director of VISN 1, created a grant program to offer trials within the VISN. As he explained to U.S. Medicine, “it is our hope to increase clinical trials available to veterans in the VA New England Healthcare System. This expands their access to emerging therapies. It also leverages our integrated healthcare system to speed the development of important new clinical knowledge that can benefit veterans across the country and, indeed, all Americans.”
Working with the Southwest Oncology Group and the Massachusetts Veterans Epidemiology Research and Information Center, Rose started pulling together data from patients and resources from within the VISN to create a clinical trials network. Today, there are 17 cancer clinical trials in the region, in addition to 20 in cardiology, mental health, maternity care and Gulf War Illness, among others.
Veterans had previously received referrals to clinical trials in the community. “The problem has been that veterans feel comfortable within the VA system. When we refer out, they often decide not to participate,” said Herta H. Chao, MD, PhD, cancer clinical trial director and deputy chief of hematology and oncology for the West Haven VAMC. Patients with post-traumatic stress disorder may find it challenging to be in a new environment. Others may face obstacles with transportation or worry that a new medical team will not understand their comorbidities or particular concerns as a veteran.
“We really feel as a group that clinical trials need to be standard of care for oncology patients. And we need to offer them within the VA,” Chao told U.S. Medicine. Participating in trials enable veterans to receive cutting edge treatment and to advance the research needed to create new ones.
In Connecticut, “we have a protocol that allows us to screen patients and match them to clinical trials. Members of our research team reach out to the patients’ providers to inform them about clinical trial opportunities that may be available to their patients.” Not all the trials offer a cure, but that does not stop veterans from signing up.
The ONCOCYTE study open in West Haven, for example, is not a therapeutic trial. It hopes to identify biomarkers in the blood of patients with lung cancer or lung nodules that will enable earlier diagnosis of lung cancer. “Veterans understand that not everyone benefits from clinical trials, but they think, ‘If I don’t help myself, at least I help other people,’” Chao said. “Veterans are very altruistic.”
Another trial that has significant implications for veterans is evaluating the cognitive effects of androgen deprivation therapy for prostate cancer, Chao’s area of research. “We know that, when patients get androgen deprivation therapy, they can experience subtle, but real cognitive effects. Many have reported this, but it hasn’t been studied,” Rose said.
In the trial, patients have functional magnetic resonance imaging (fMRI) and take a battery of cognitive tests to see what changes occur with treatment. “It’s very veteran-centric research, as prostate cancer is the most common cancer among veterans. Veterans are excited to participate in it, even though it’s not therapeutic,” Rose added.
Like the prostate cancer study, the clinical trials generally focus on veteran-centric cancers. Because at the VA, “the types of cancer we see most are lung, prostate, colorectal, chronic lymphocytic leukemia and multiple myeloma, we try our best to have open trials that target those conditions,” said Samuel Rosa, MPH, RRT, CCRP, the research health science specialist and lead coordinator for the White River Junction Clinical Trials Program. “That being said, we have a diverse portfolio of open trials that include other malignancies as well.” White River Junction currently has nine open cancer trials.
Most trials involve potentially therapeutic agents. “We remind ourselves that immunotherapies were not available just a few years ago, now 20% of patients are lucky and respond very well to them,” Chao said. “In order for the VA to be competitive and provide the best care possible, we must treat clinical trials as clinical care and invest in them.”
While the therapeutic agents studied in the trials are typically provided for free, the time of the research coordinators, clinical pharmacists, patient protection managers and physicians can be expensive. “There’s a lot of work behind the scenes; I may spend two hours ting to identify a patient for a specific trial. That’s not anything that any data will show in my productivity,” Rose said.
Frequently, allocations of a few thousand dollars per patient for trials is not enough to conduct all the tests needed, let alone pay the research support staff for their time, Chao noted.
VISN 1 has been a notable exception. “It’s been incredibly supportive of clinical cancer trials, including establishing a process in which investigators can use the NCI and the VA central institutional review board and helping investigators work out fine details and manage the paperwork involved,” she said.
That support is critical, Rose said. “Many physicians struggle to get a study open; they face issues on information security, how tests are going to be charged, how the physician, nurse and coordinator will bill their time. The administrative group here is vocally supportive and concerned about the quality of care for veterans in Connecticut.”