Click here to view as PDF.
While clinical studies and personalized medicine are clearly the future of cancer treatment, barriers to patient participation come from several directions, including patients, physicians, and the insurance industry. A US Oncology– sponsored survey of oncologists and clinical research professionals found them to be highly optimistic about the future of clinical trials in advancing personalized medicine, despite concerns about the various hurdles. The national survey of 299 oncology and clinical research professionals determined that 58% of respondents were optimistic about trials, while only 25% were ambivalent or unsure (Table
The study used a blinded survey, with interviews collected between June 29, 2009, and July 6, 2009. The majority of responses (67%) came from a mix of oncologists in medical, radiation, surgical, and hematology specialties; and the remaining 33% were clinical research professionals, such as trial coordinators, study managers, and physicians/investigators (Figure
).Patient Communication Is Key
Matthew Galsky, MD, a medical oncologist with Comprehensive Cancer Centers of Nevada, which is affiliated with the US Oncology network, said he shares respondents’ optimism about the future of clinical trials and the importance of personalized medicine. His practice has approximately 50 trials open at any time, of which approximately 5% have a personalized medicine component.
“We’ve known for as long as chemotherapy has been around that a subset of patients benefit tremendously, and a large proportion don’t benefit at all,” Galsky said. “Yet, we still expose everyone to the same treatment.” He explained the benefit of being able to identify which patients are more or less likely to respond before starting them on therapy. “If we can identify and only treat that subset, and perhaps target the other patients with a newer treatment that might make them more likely to respond overall, we’ll increase the number of patients who benefit and decrease the number of patients suffering side effects.”
More than half (53.2%) of the oncologists and clinical research professionals who responded to the US Oncology survey agreed that recruiting patients for clinical trials designed to evaluate targeted therapies would be less difficult than getting them to enroll in largescale randomized trials of more traditional cytotoxic therapies. At the same time, some patients are reluctant to try investigational drugs.
Galsky employs a philosophy of open and proactive communication that breaks down what he sees as one of the primary barriers to patient participation in trials—patients’ misperception that they will be used as guinea pigs. “I talk to patients about the fact that any current standard treatment options are only standard treatment options because they were the subject of clinical trials several years ago. Hopefully, what we’re studying now will be the next standard of care; it’s an opportunity that will favorably alter the natural history of their cancer sooner.”
The majority of oncologists surveyed (85%) said another benefit of patient participation is when the trial provides treating physicians with genetic test/biomarker information that they can use to manage their patient’s disease. More than three-quarters (77%) said the opportunity to obtain results of a genetic test or biomarker information would influence them to present a trial to a patient. Approximately one-third (33%) of the oncologists said their patients worried, however, that results from these tests might be used against them when seeking insurance coverage. The Genetic Information Nondiscrimination Act (GINA), which took effect in November 2009, prohibits health insurers and employers from discriminating against individuals based on their genetic information, and communicating this to patients might alleviate some of their concerns.Reimbursement Another Obstacle
Respondents reported cost and reimbursement as clear barriers to trial participation. More than half of survey respondents said mandated health plan coverage was the most important factor in encouraging patient participation. In addition, more than three-quarters (85%) of respondents indicated that cost/reimbursement alignment affects their ability to treat patients with a personalized medicine approach at least some of the time.
Galsky agrees that insurance is a growing issue that has the potential to dampen accrual, but he expressed surprise that respondents considered it the biggest obstacle, noting that it affects less than 10% of patients significantly. He sees reimbursement as just one of many obstacles, which include lack of time, lack of available studies, and lack of interest. With less than 10% of adults in the United States enrolled in a clinical trial, Galsky said, “We certainly need to look at many other factors that can increase the pool of eligible patients. It has to do with availability of a trial, patient and physician barriers, and the fact that most clinical trials are designed to enroll a patient population…on the healthier side.”