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Barriers to Clinical Trial Enrollment

Barriers to Clinical Trial Enrollment

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).

Physician Referrals

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.

Patients’ Participation

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.

Insurance Coverage

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 insurance.

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."

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