Another health disparity: clinical trials

Cancer patients who live on less than $50,000 a year take part in clinical trials at a rate one-third lower than those who make more annually, according to a study published Thursday in JAMA Oncology.

Because clinical trials often provide the most cutting edge – if still unproven – treatments, the finding is a new example of how income disparities translate to unequal access to medical care.

In addition, the absence of low-income participants slows the time needed to recruit volunteers for clinical trials and makes researchers’ findings less representative of the general population, said Dr. Joseph Unger, a biostatistician and health services researcher in Fred Hutchinson Cancer Research Center’s Public Health Sciences Division and the paper’s lead author.

Enrolling more low-income patients would be “a benefit for both researchers and for patients,” Unger said.

 “The research benefits because you can do trials more quickly and they would be more representative,” he said. “For patients, clinical trials are a vital resource, so there shouldn’t be a disparity depending on your income.”

Clinical trials are the only accepted scientific method to test if a new treatment is safe and effective in humans. In addition to new therapies, some trials test giving already approved drugs at lower doses, on different schedules or in new combinations, which could improve care.

Yet nationwide, only 3 to 5 percent of adult cancer patients take part in federally funded clinical trials, a rate that has not budged in years. An earlier study found that a lack of volunteers — not treatment failure or toxicity — was the main reason one in five adult cancer trials were never completed.

The new study found that the lower a patient’s income, the lower the chance that he or she will take part in a clinical trial. Just 11 percent of those surveyed making less than $20,000 a year took part in clinical trials, compared with 13 percent of those making between $20,000 and $49,999 and 17 percent of those making more than $50,000.

The study used data from a prospective survey of barriers to participation in clinical trials conducted in eight geographically diverse U.S. cancer clinics, including Seattle Cancer Care Alliance, Fred Hutch’s treatment arm. All are members of SWOG, a cancer research cooperative group that designs and conducts multidisciplinary clinical trials. Centers that specialize in cancer care typically have higher rates of clinical trial participation than general or community hospitals, in part because patients who seek care there are often hoping to find an experimental therapy and in part because doctors and staff there are more likely to talk to patients about clinical trials.

But even given that people in the survey took part in trials at a higher rate overall than the national average, income disparities influenced participation, Unger said.

In most clinical trials, the study sponsor covers research costs and the cost of the treatment under study, but that doesn’t mean that there are no out-of-pocket expenditures. Patients — or their insurance companies — are responsible for routine health care costs associated with the study, including any other drugs, procedures or services needed during the trial period.

Many insurance policies as well as Medicare do pay routine costs that would be covered if the patient were receiving standard treatment. But for those with nothing to spare financially, even insurance co-pays can be a deterrent to trial participation. In addition, there can be hidden costs to enrolling in clinical trials that affect even people with insurance, particularly those who live far from a major research center.

The paper called for future research on how to overcome financial barriers to trial participation, such as reimbursing co-payments or providing compensation for time off work, transportation and child care. Unger acknowledged that such steps would have to be carefully designed so as not to unduly influence someone’s decision to take part in a trial.

“We want to avoid being coercive to patients by adding incentives,” he said. “I personally think it wouldn’t take a lot to help level the playing field without being coercive.”

The passage of the Affordable Care Act took some steps in that direction, said Dr. Beti Thompson, head of Fred Hutch’s Health Disparities Research Center, who was not involved in the study. Under the health care reform bill passed in 2010, all insurance companies are required to cover routine costs for patients participating in approved, federally funded clinical trials, unless a policy was grandfathered in and is not subject to the reforms.

But other restrictions may apply, such as whether the doctor or medical center overseeing the trial is in the patient’s network.  And the health care reform law does not apply to Medicaid; coverage of routine care varies by state.

Unger hopes that the new findings may help influence coverage in a similar way as an earlier study that he and fellow researchers published in 1999 on the lack of participation by older patients in clinical trials. The following year, President Bill Clinton mandated that Medicare cover routine costs of patients entering clinical trials.  However, Medicaid, the public insurance program for the poor, is under state control, making nationwide reforms more challenging.

Thompson agrees that a lack of insurance coverage or extra money for additional charges discourages low-income cancer patients from “going the extra mile for treatment.”

Another factor is that many of the underserved are being treated at community hospitals and just don’t hear about clinical trials.

“We need to do a lot more at the community level to educate people about the importance of clinical trials and to let them know that once they go through traditional treatments, there may be other options for them,” said Thompson, who has worked for more than 25 years with Latino communities in Washington state’s Yakima Valley and in other medically underserved communities. “We put things on the Internet and have elaborate documents about how clinical trials work, but we really need to go to where the people are and talk to them.”

Besides Unger, authors of the JAMA Oncology paper, published as a research letter, include Dr. Julie Gralow, a member of Fred Hutch’s Clinical Research Division and director of Breast Medical Oncology at Seattle Cancer Care Alliance; Dr. Scott Ramsey, director of the  Hutchinson Institute for Cancer Outcomes Research, or HICOR; and researchers from the University of Washington; Loyola University, Chicago; Stritch School of Medicine; and Columbia University