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Researchers identify barriers to cancer clinical trials enrollment

Most patients do not participate in cancer clinical trials because they did not want to use investigational treatments, even though entry into such trials is frequently associated with a higher survival rate, according to researchers at the University of California Davis Cancer Center.

This study was conducted to determine the barriers to cancer clinical trial enrollment. Of the 76 patients who were recommended by their physician to participate in a clinical trial for which an appropriate trial was available, and who met eligibility criteria, nearly half (49 percent) of these patients refused to participate in a trial. Thirty-four percent of these patients said they did not want to use investigational treatments; 13 percent said they lived too far from the cancer center; 8 percent were denied coverage by their private insurance company for the costs associated with the trial; and 5 percent feared randomization.

In the study of 276 patients, researchers found that physicians themselves failed to refer approximately 38 percent of these patients to clinical trials even before reviewing the patient’s eligibility. Doctors assumed that no clinical trial was available or that the 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 some of the excluded patients may have been eligible, according to the researchers.

While the overall accrual rate of 14 percent for trial participation in this study was better than the national average of 2 to 4 percent, understanding the reasons why few patients ultimately enroll in cancer clinical trials is the first step to reversing the trend, says lead author, Primo Lara, Jr., MD, an assistant professor of medicine at the University of California Davis Cancer Center.

"Cancer clinical trials are essential for improving outcomes in cancer patients," Dr. Lara said. "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." More problematic is the issue of insurance reimbursement, which is best addressed through federal legislation, he said. In this study, patients with private health insurance were found to be less likely to participate in cancer clinical trials compared to those with government insurance. He is concerned that insurers will increasingly deny coverage until effective legislation on mandatory third party coverage for the routine costs of clinical trials is passed.

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