Barriers to minority clinical trial participation identified by study

The study, published online today in Cancer, found variations in how the cancer centers gather patient demographic information and other relevant data. The research was part of a national effort to recruit more racial/ethnic minorities into therapeutic clinical trials and, ultimately, to reduce the disproportional incidence of many cancers among those populations.

UC Davis is one of five National Cancer Institute-designated comprehensive cancer centers united in the endeavor, known as EMPaCT -- Enhancing Minority Participation in Clinical Trials. Funded by the National Institute of Minority Health and Health Disparities, the consortium is in the second phase of its work to address barriers that limit the representation of minorities in therapeutic trials.

"Racial and ethnic minorities make up more than half the nation's population, but language, culture, and other barriers historically have suppressed their involvement in clinical trials," said UC Davis Professor Moon Chen, who leads the UC Davis EMPaCT team. "Clinical trials are critical to our development of effective cancer therapies, and we must have participation by meaningful numbers from all racial/ethnic groups to ensure those therapies are based on specific characteristics of these populations."

Clinical trials evaluate the effectiveness and safety of cancer medications and medical devices by monitoring their effects on large groups of people. Such trials are considered vital to the development of cancer therapies, and inclusion of people from all racial/ethnic populations and both genders is particularly important as the U.S. becomes more diverse.

The study reviewed the collection and reporting of patient demographic data and other practices by the five regionally diverse cancer centers participating in EMPaCT. Investigators found significant variation in the methods of data collection and type of patient demographic information by the five centers.

The centers also differed in how they defined their patient "catchment area," or geographic region they expect to influence with their programs. That issue merits notice because under National Cancer Institute guidelines, comprehensive cancer centers are required to accrue women and minorities to clinical trials in rough proportion to the cancer patient population of the center's primary catchment area.

Given the findings, investigators recommend better standardization of data definition, collection, and reporting as an essential first step toward expanding minority participation in clinical trials. The study's authors also advise that cancer centers should collect socioeconomic data, including a patient's income and education levels, given compelling evidence of the strong link between socioeconomic status and cancer outcomes.

Finally, the authors recommend collecting patient zip codes and insurance status to allow researchers to assess differences in access to clinical trials that may be related to geography and the availability of health insurance coverage.