Reluctance to Try Investigational Treatment, Insurance Denials Keep Patients from Clinical Trials


Many cancer patients decline to participate in
clinical trials because they do not want to use investigational
treatments, even though studies indicate patients who enroll in these
studies have better outcomes, according to researchers at the UC Davis
Cancer Center.

Primo Lara, an assistant professor of medicine at the UC Davis Cancer
Center and lead author of the study, will present his findings at the
annual meeting of the American Society of Clinical Oncology in San
Francisco on Sunday, May 13.

Advances in cancer treatment depend on carefully controlled studies of new
treatments, yet only two to four percent of cancer patients nationwide
take part in them.

In the UC Davis study, almost half of the 76 cancer patients whose doctors
recommended they take part in a study and who met eligibility criteria
opted not to.

Thirty-four percent said they wanted other treatment, either because they
wanted more control over the process, they were wary of investigational
treatments or they preferred to use alternative medicine.

Thirteen percent declined because they felt they lived too far from the
cancer center and eight percent said no because their private insurance
denied coverage for costs associated with clinical trials.

But barriers to clinical trials extend beyond patients. Doctors declined
to refer 38 percent of the surveyed patients to clinical trials, thinking
that no trials were available or that their patients were too sick to be
accepted. However, more than 150 clinical trials were available during the
study period. It was possible some of the excluded patients would have
been eligible, Lara said.

"Cancer clinical trials are essential for improving treatment and
prolonging the lives of people with cancer," said Lara. "The barriers to
participation we've identified could be reduced through patient education
about the value of clinical trials."

"Doctors can do a lot to assuage their patient's concerns by talking to
them about the process," he added.

The overall enrollment rate for patients in this study was 14 percent,
well above the national average but on par with accrual rates for major
medical centers and teaching hospitals.

Understanding why so few patients participate in clinical trials is the
first step to reversing the trend, Lara said.

A common misconception about clinical trials is that patients are
volunteering for treatments that may not work. In reality, Lara said, many
investigational treatments are at least as effective as conventional
therapy when they are tested on cancer patients in clinical studies.

At the same time, previous research has shown that cancer patients who
participate in clinical trials frequently have higher survival rates.

The problem of insurance reimbursement is more problematic, said Lara, and
should be addressed through legislation. In the UC Davis Cancer Center
study, patients with private health insurance were less likely to take
part in cancer clinical trials than those with government insurance.

Private insurers routinely deny coverage of routine medical care to cancer
patients enrolled in clinical trials.

Lara's study was published in the March 13 issue of the Journal of
Clinical Oncology. Partial funding was provided by an American Cancer
Society clinical research training grant awarded to Lara in 2000.