A new study involving researchers from UC Davis and four other National Cancer Institute-designated cancer centers reveals important barriers that limit minority group participation in cancer clinical trials, findings that will be used to refine and launch more effective strategies to assure that more minorities benefit from clinical trials.
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.
In addition to UC Davis, which represents the West and targets the accrual of Asian Americans, the cancer centers participating in EMPaCT are University of Minnesota, Minneapolis, lead institution (Midwest – Native American and African American accrual); University of Alabama, Birmingham, co-lead institution (Southeast - African American accrual); Johns Hopkins University (East – African American accrual), and University of Texas M.D. Anderson in Houston (Southwest – Latino/Hispanic accrual).
The research was funded with a grant from the National Institute on Minority Health and Health Disparities 1U24MD006970.
UC Davis Comprehensive Cancer Center is the only National Cancer Institute-designated center serving the Central Valley and inland Northern California, a region of more than 6 million people. Its specialists provide compassionate, comprehensive care for more than 10,000 adults and children every year, and access to more than 150 clinical trials at any given time. Its innovative research program engages more than 280 scientists at UC Davis, Lawrence Livermore National Laboratory and Jackson Laboratory (JAX West), whose scientific partnerships advance discovery of new tools to diagnose and treat cancer. Through the Cancer Care Network, UC Davis collaborates with a number of hospitals and clinical centers throughout the Central Valley and Northern California regions to offer the latest cancer care. Its community-based outreach and education programs address disparities in cancer outcomes across diverse populations. For more information, visit cancer.ucdavis.edu.