Most patients do not want to
use investigational treatments
even though entry into cancer clinical trials is frequently associated with a
higher survival rate. This is just one of the reasons why patients do not
participate in trials, according to researchers at the University of California
Davis Cancer Center, who conducted a study to determine the barriers to cancer
clinical trial enrollment.
"Understanding the reasons why few patients ultimately
enroll in cancer clinical trials is the first step to reversing the trend,"
according to Primo Lara, Jr, MD, assistant professor of medicine at the
University of California Davis Cancer Center and lead author of the study, which
was recently reported in the Journal of Clinical Oncology (19:1728-1733, 2001).
While the overall accrual rate of 14% for trial participation in
this investigation was better than the national average of 2% to 4%, researchers
found that physicians failed to refer approximately 38% of the 276 patients
studied even before reviewing their eligibility. Doctors assumed that no
clinical trial was available or that patients were too sick to be included.
However, there were more than 100 clinical trials available at the cancer center
for various tumor types during the study period and, according to the
researchers, some of the excluded patients may have been eligible.
Of the 76 patients who met eligibility criteria and were
recommended by their physicians to participate in a clinical trial, nearly half
(49%) refused to participate. Of these patients, 34% said they did not want to
use investigational treatments, 13% said they lived too far from the cancer
center, and 5% feared randomization.
In this study, 8% of patients were denied coverage by their
private insurance company for the costs associated with the trial. Moreover,
patients with private health insurance were found to be less likely to
participate in cancer clinical trials compared to those with government
The issue of insurance reimbursement is problematic and best
addressed through federal legislation, according to Dr. Lara. He also expressed
concern that insurers will increasingly deny coverage until effective
legislation on mandatory third-party coverage for the routine costs of clinical
trials is passed.
"Cancer clinical trials are essential for improving
outcomes in cancer patients," Dr. Lara concluded. "The barriers to
participation we’ve identified could be reduced through patient and physician
education and by providing access to clinical trials through programs that are
closer to where people live."