New law eliminates a major barrier to
cancer clinical trials, UC Davis study shows

A California law enacted in January 2001 appears to have removed a major barrier to participation in clinical trials by cancer patients, according to research presented this week at the annual meeting of the American Society of Clinical Oncology. The law requires private and government health insurance plans to cover routine costs associated with cancer clinical trials, the studies that fuel advances in cancer treatment.

“A factor we found to be a significant barrier before the new law took effect — health insurance limitations — was no longer significant after passage of the law,” said Primo N. Lara, Jr., assistant professor of hematology & oncology at UC Davis Cancer Center. “This is preliminary but encouraging data. Our study suggests that perhaps California’s law has removed an important barrier to clinical trial participation.”

Lara and his colleagues first looked at barriers to clinical trial participation in 2000, a year before the California Legislature passed SB 37. In that initial study, 8 percent of the cancer patients who were eligible for a clinical trial declined to participate, citing health insurance limitations as the reason.

In the new study, conducted a year after SB 37 took effect, no cancer patient declined to participate in a clinical trial because of insurance limitations.

The new study also found no difference in participation rates between patients with private and government health insurance. In the initial study, in contrast, those with government health insurance were significantly more likely to participate in a clinical trial. Before SB 37, private insurers routinely denied coverage of cancer clinical trial costs.

Although insurance was no longer cited as a barrier, participation rates increased only slightly from the first study to the second. In the first study, 51 percent of cancer patients who were eligible for a clinical trial chose to enroll in one. In the second study, the participation rate was 69 percent.

Lara hopes that increasing awareness of SB 37 among California cancer patients and their physicians will raise participation rates more dramatically. He is launching a new study in which a mass media advertising campaign will be developed and used to educate Californians about the new law. As part of the study, Lara and his colleagues will track the campaign's impact on clinical trial enrollment.

Advances in cancer treatment depend on clinical trials, carefully controlled scientific studies of new therapies. Yet less than 3 percent of adult cancer patients nationwide enroll in these trials each year, a rate that hasn't improved in more than two decades. Low participation rates prolong drug development and delay patient access to potentially beneficial new agents.

California was the 14th state to pass a law requiring insurers to pay medical costs associated with cancer clinical trials. The law was authored by state Sen. Jackie Speier (D-Hillsborough) and signed by Gov. Gray Davis.

The Cancer Leadership Council, Cancer Research Foundation of America, Coalition of National Cancer Cooperative Groups, Oncology Nursing Society and American Society of Clinical Oncology together have set a goal of doubling participation in cancer clinical trials over the next three to five years.

UC Davis Cancer Center has one of the most vigorous clinical trials programs in the country. About 14 percent of new cancer patients seen at the Cancer Center participate in a clinical trial.

For the year 2001, UC Davis Cancer Center ranked first among Southwest Oncology Group (SWOG) centers in the number of patients enrolled in trials. Sponsored by the National Cancer Institute, SWOG is one of the world's largest cancer clinical trials organizations. Its membership consists of nearly 4,000 of the nation's leading physicians at 283 institutions throughout the United States and Canada. Over the past 13 years, SWOG-sponsored research has yielded 10 new U.S. Food and Drug Administration-approved cancer therapies.