AACR: Minority accrual in clinical trials is a team sport

Regulatory NewsRegulatory News | 23 June 2020 |  By 

Those who conduct clinical trials are missing a broad swath of the US population, with implications that not only reach into issues of equity and justice, but may also limit the generalizability of study findings, said a cancer researcher speaking at the American Association for Cancer Research annual meeting.
“Without adequate minority representation, it is difficult for us to fully be able to generalize the effects regarding the toxicity or efficacy or a medication,” said Ruben A. Mesa, MD, director of the Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center.
Though the US has almost 59 million Hispanic residents, representing 18% of the population, Hispanic participants represent fewer than 8% of clinical trial enrollees and fewer than 1% of those enrolled in National Institutes of Health-funded research.
In the US, Latinos represent the largest minority population; numbers of Latinos in the US are growing rapidly and geographic distribution is widening, said Mesa, adding that cancer cases among Latinos are projected to increase by 132% by the year 2030, as the Latino population is project to double by 2060.
Although the smoking rate is low among Latinos, lung cancer is the leading cause of death in Latino men, and breast cancer is the leading cause of cancer death in Latina women. Latino men with prostate cancer are less likely to receive treatment than Caucasian men, just one of many health disparities, said Mesa.
Additionally, Latinas are less likely to receive breast cancer screening, which makes it more difficult for them to become research participants. Cost, lack of insurance, language barriers, a sense of fatalism, and mistrust of doctors and the medical system have all been found to be contributors to this disparity.
In considering recruitment and participation of Hispanic and Latino individuals in clinical trials, it’s important to understand that the terms encompass “a very diverse set of persons from many different regions, each with a different response to treatment and disease progression,” noted Mesa. “Unique genetic and environmental factors render Latinos disproportionately susceptible to certain cancers.”
Within the catchment area of the UT Health San Antonio MD Anderson Cancer Center, 69% of the 4.9 million residents are Hispanic, and 41% are non-English speaking; Hispanic residents overall tend to be younger, poorer, and have less education than non-Hispanic residents, said Mesa.
At Mesa's facility, a comprehensive community outreach and engagement effort to have these figures reflected in the clinical trial population includes biostatisticians and bioinformaticians as well as community outreach workers and communicators. The scope of research includes population science and prevention work, but also work that contributes to the development of cancer therapeutics. These areas of research include experimental and developmental therapeutics and cancer development and progression. A clinical trial minority accrual committee works closely with the research teams, he added.
Three areas of focus have been targeted for the community outreach and engagement work. The first is cancers of focus, which centers on cancers that disproportionately affect the Latino/Latina community because of higher prevalence or differences in detection and treatment. The second focus is to advance the science of cancer in the Latino population, and the third addresses the modifiable cancer burden in the population.
Looking specifically at South Texas, Mesa said that researchers at his institution have identified the cancer burden for Hispanic individuals, comparing age-adjusted incidence rates of common cancers for the Hispanic and non-Hispanic population of South Texas.
Knowing the numbers has helped Mesa and his colleagues develop specific strategies to improve minority accrual. First, barriers were identified through focus groups, interviews, and physician outreach. Then, the team developed specific strategies including having a full suite of Spanish-language materials and boosting the number of interpreters on hand. Finally, researchers spread information about clinical trials through expanded outreach in Spanish-language media. 
Now, all trials are required to have a clinical trials minority accrual plan. A 10-member committee works with investigators to reduce barriers to minority patient accrual and continue to implement the strategies that enhance recruitment.
Progress toward enhanced minority recruitment is measured and reported, so the entire team can see what works and what doesn’t. Another lesson learned, though, is that a one-size-fits-all approach is not the solution. “Indeed, every trial is distinct,” said Mesa. “One solution cannot be universally applied.”
Now, over half the patients who enroll in clinical trials at Mesa’s facility are Hispanic, and the team continues to focus on broad minority recruitment across races and ethnicities as well.
Mesa disclosed that he performs consulting for Novartis, La Jolla, Samus, Sierra Oncology and Blueprint, and that he receives research support for Incyte, Celgene, CTI, Promedior, Genentech, Abbvie and Imago.


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