The findings suggest that informational campaigns may be effective strategies to boost participation in clinical trials in the general population. But additional strategies may be needed to increase participation by black and Asian American patients.
"Understanding the reasons behind low rates of enrollment in clinical trials and developing strategies to overcome these barriers is essential," said Primo N. Lara, Jr., associate professor of hematology and oncology at UC Davis and lead author of the new study. "It's especially important to increase the participation of minority populations -- otherwise, the conclusions we reach in cancer clinical trials may not apply to minority patients."
Lara, one of the nation's leading experts on the subject of barriers to cancer clinical trial participation, undertook the study to develop baseline data against which to measure the impact of future interventions. The study is among the first large-scale investigations of its kind to prospectively assess patient-related barriers to participation in cancer clinical trials.
In the study, Lara and his colleagues surveyed 1,188 cancer patients and their family members between October 2003 and April 2004. He found that 59 percent of those surveyed knew that a cancer clinical trial tests the safety and effectiveness of new anti-cancer agents; 19 percent knew about SB 37, a California law that requires insurance companies to cover cancer clinical trials; and 36 percent agreed that if they had cancer and were asked to be in a clinical trial, they would be likely to consider participating.
The study also found that people were more likely to consider participating in a clinical trial if they understood what one is and knew that trial costs would be covered by insurance.
Such awareness was lower among blacks and Hispanics, those with annual incomes below $25,000 and those without college degrees.
Willingness to consider participation in a trial was lower among blacks, Asians and those under 24 years old.
"We found that the reluctance of blacks and Asian Americans to participate was independent of their degree of knowledge about clinical trials. The same was true for people under 24 years of age," Lara said. "This suggests that other personal experiences or characteristics play a deciding role for people in these groups, and that we may have to go beyond just increasing awareness to impact their willingness to participate in clinical trials."
Advances in cancer treatment depend on clinical trials. Yet fewer 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. When minority populations participate at low rates, physicians and scientists are left with less information about how new drugs work in these populations.
Lara's research is funded by a 2003 grant from the National Institutes of Health through the National Cancer Institute, in partnership with Aventis, Bristol-Meyers-Squibb, GlaxoSmithKline, Eli Lilly and Novartis Pharmaceuticals. The public-private partnership was formed to help speed new cancer treatments to patients, in part by reducing barriers that prevent cancer patients from enrolling in clinical trials.
UC Davis Cancer Center is the only National Cancer Institute-designated cancer center serving the Central Valley and inland Northern California, a region of 5 million people. It has one of the most vigorous clinical trials programs in the country, with about 14 percent of new cancer patients participating in a clinical trial.
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Journal of Clinical Oncology