The VA Portland Health Care System is one of 12 centers across the U.S. selected for a national initiative to give military veterans more opportunities to participate in cancer clinical trials.
The chosen VA facilities will gain direct and speedy access to clinical trials carried out through the National Cancer Institute’s National Clinical Trials Network and the NCI Community Oncology Research Program. The veterans’ hospitals will receive funding for three years to help cover the administrative costs of running trials and establishing a stable infrastructure for ongoing clinical research.
“It is going to be transformational for this VA,” said Mark Garzotto, M.D., a staff urologist with the Portland VA and professor in the OHSU School of Medicine. Garzotto is the principle investigator for the award from the NCI and VA Interagency Group to Accelerate Trials Enrollment program, or NAVIGATE.
“The most impactful thing we can do to move the science forward and potentially improve patient care here is to bring clinical trials into this hospital and make it more a part of the culture,” Garzotto said.
Veterans’ access to trials sponsored by the National Cancer Institute and other groups has eroded in the past 20 years for reasons mostly stemming from a lack of funding from study sponsors to support clinicians and staff whose primary responsibility is to meet the regular care needs of large numbers of patients.
“The VA is so busy the last thing physicians had time to do was sit and explain a clinical trial for a half hour,” Charles Blanke, M.D., told STAT News in 2016, when he championed a program offering competitive seed funding to VA medical centers to help them enroll veterans in trials run by SWOG and other members of the National Clinical Trials Network. Blanke is a professor in the OHSU School of Medicine and group chair of SWOG.
Working with the OHSU Knight Cancer Institute, the VA Portland Health System has managed to offer a range of clinical trials. Together, for example, the two institutions enrolled more subjects than any other trial site in the country in a study published in February establishing the prostate cancer drug apalutamide, the first agent approved for men with tumors that have become resistant to hormone therapy but have not yet spread. That trial was overseen by Julie Graff, M.D., section chief of hematology and oncology at the VA Portland Health Care System and member of the OHSU Knight Cancer Institute.
“This will greatly speed up the approval process,” Garzotto said. “In some patients with cancer time is critical.”
Studies involving patients require approval by an ethics board, called an institutional review board or IRB. For trials initiated via the NAVIGATE program, reviews will be performed by a national IRB supported by the NCI. Rather than each participating institutions having to review a study on cancer from scratch, the central IRB has the authority to conduct one thorough review that will then serve all participating sites.
“This will greatly speed up the approval process,” Garzotto said. “In some patients with cancer time is critical. If we see a patient with, let’s say a rare tumor, and there is a relevant trial open in the NCI docket, then we can potentially get it activated and enroll that patient and get them access to treatments that would not otherwise be available to them.”
The NAVIGATE program funding will help VA medical centers dedicate the staff needed to support clinical trials. Each VA medical center will get $150,000 per year for three years. Centers will receive additional funding for each patient accrued into NCI cooperative clinical trials.
The award should help VA medical centers to structure their cancer clinical trial portfolios to offer hope and more options of potential benefit to veterans who are not responding to current standards of care. There are certain cancers where the occurrence rate in veterans is higher than in the general public. Those with a history of exposure to Agent Orange, for example, have higher rates of sarcoma, aggressive prostate cancer, and some hematologic malignancies. Hepatitis C infection is more common in the veteran population, increasing the risk of hepatocellular carcinoma. Trials enrolling veterans, as a result of the NAVIGATE award, may allow for better treatments to be discovered.
Affiliation with the OHSU Knight Cancer Institute was a key factor helping the VA Portland Health Care System successfully compete for the NAVIGATE award, Garzotto said. His co-investigators are Graff, the prostate cancer clinical trial leader, and Charles R. Thomas Jr., M.D., professor and chair of the Department of Radiation Medicine at OHSU.
NIH and VA collaborate to boost veterans’ access to cancer clinical trials, NIH news release (July 2018)
Shut out for decades, veterans slowly gaining access to innovative cancer treatments, by Bob Tedeschi, STAT News (March 4, 2016)