Despite progress, certain populations remain underrepresented in cancer clinical trials
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Although cancer clinical trial participation has increased among Black and Hispanic individuals, these populations — along with women and older adults — remained underrepresented, according to a study published in Cancer.
The results, based on an analysis of data collected during a 20-year period, highlighted the need for recruitment strategies to address disparities in clinical trial populations.
“Recent efforts to increase minority participation has had success but further work is needed,” Juan Javier-DesLoges, MD, MS, urologic oncology fellow in the department of radiation medicine and applied science at Moores Comprehensive Cancer Center at UC San Diego Health, told Healio.
The NCI implemented several initiatives designed to address heterogeneity of clinical trial participation.
Javier-DesLoges and colleagues set out to determine representation of minority groups, women and older adults in NCI-sponsored clinical trials because such analysis had not been performed in 2 decades.
“The original work — written by U.S. Surgeon General Vivek Murthy, MD, MBA, when he was a medical student, and Cary Gross, MD, [professor of medicine and public health and director of the National Clinician Scholars Program at Yale School of Medicine] — is nearly 20 years old and no study to date has examined year-to-year trends in minority participation,” Javier-DesLoges said. “Nearly all studies lump the patients together in 20-year groups.”
In the current study, researchers evaluated representation by age, sex, and race/ethnicity in 766 NCI Clinical Trial Cooperative Group trials for breast, colorectal, lung and prostate cancers from 2000 to 2019.
The analysis included 242,720 adults (median age, 66.2 years; 71.7% women), of whom 81.3% were non-Hispanic white, 8.7% were Black, 4.8% were Hispanic and 2.8% were Asian/Pacific Islander.
Javier-DesLoges and colleagues performed multivariable logistic regression analysis for each cancer type to determine the odds of participating in a clinical trial from 2015 to 2019 compared with 2000 to 2004, adjusting for age, sex and race/ethnicity. They hypothesized that disparities in participation may have improved over time.
Results showed that when comparing clinical trial participation from 2015 to 2019 to the proportion of cancer incidence from 2015 to 2017 for breast cancer, non-Hispanic white patients were more likely to participate in clinical trials than Black patients (OR = 1.75; 95% CI, 1.67-1.83) and Hispanic patients (OR = 1.19; 95% CI, 1.12-1.25). Both groups also were underrepresented in colorectal cancer (Black, OR = 0.58; 95% CI, 0.5-0.67; Hispanic, OR = 0.74; 95% CI, 0.64-0.87), lung cancer (Black, OR = 0.83; 95% CI, 0.76-0.91; Hispanic, OR = 0.66; 95% CI, 0.57-0.77) and prostate cancer trials (Black, OR = 0.58; 95% CI, 0.51-0.66; Hispanic, OR = 0.85; 95% CI, 0.79-0.92).
In comparing trial representation from 2015 to 2019 of women and men to proportion of cancer incidence from 2015 to 2017, researchers found underrepresentation of women in colorectal cancer (OR = 0.73; 95% CI, 0.67-0.79) and lung cancer trials (OR = 0.89; 95% CI, 0.83-0.93). In the same analysis structure, patients aged older than 65 years were underrepresented in breast cancer (OR = 0.27; 95% CI, 0.27-0.28), colorectal cancer (OR = 0.36; 95% CI, 0.33-0.39) and lung cancer trials (OR = 0.59; 95% CI, 0.56-0.62).
Meanwhile, the odds of participation in 2015 to 2019 compared with 2000 to 2004 increased among Black and Hispanic patients in breast cancer (Black, OR = 2.19; 95% CI, 2.07-2.32; Hispanic, OR = 3.32; 95% CI, 3.09-3.56), lung cancer (Black, OR = 1.54; 95% CI, 1.38-1.73; Hispanic, OR = 3.88; 95% CI, 3.2-4.69) and prostate cancer trials (Black, OR = 1.14; 95% CI, 1.04-1.26; Hispanic, OR = 1.7; 95% CI, 1.42-2.04). Participation also increased during that time among Hispanic patients in colorectal cancer trials (OR = 2.46; 95% CI, 2.04-2.96) but remained the same for Black patients (OR = 1.15; 95% CI, 0.97-1.36).
“We were anticipating that participation hadn't changed so we were surprised to see it had,” Javier-DesLoges told Healio. “Particularly, breast cancer trials have had immense success in enrolling minorities.”
Study limitations included that data only characterized NCI-sponsored cooperative group clinical trials. Javier-DesLoges and colleagues acknowledged that industry-sponsored clinical trials accounted for as many as one-third of clinical trials during the study period.
They wrote that the study was the first to indicate some participation disparities are improving, yet improvements remain essential and “if there is not appropriate inclusion of these populations, then health disparities will likely widen.”
“There are several ongoing studies into peer-to-peer navigation systems to improve recruitment,” Javier-DesLoges told Healio. “The NCI has devoted substantial resources to this issue and has had success. The continued persistence of the NCI and its clinical trials group will be critical for future participation. Additionally, nearly half of all trials are now funded privately through industry. Routine reporting of their demographic data and engagement to this issue will be essential.”
For more information:
Juan Javier-DesLoges, MD, MS, can be reached at Department of Radiation Medicine and Applied Science, Moores Comprehensive Cancer Center, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, CA 92037; email: jjavierdesloges@health.ucsd.edu.
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