Racial, ethnic minorities underrepresented in prostate cancer clinical trials
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Prostate cancer clinical trials included significant underrepresentation of Asian, Black and Hispanic men based on incidence of the disease among these groups, results of meta-analysis published in JAMA Oncology showed.
The data revealed no significant age-based disparities in enrollment, investigators reported.
Background
“Dramatic” disparities exist in prostate cancer outcomes by race, ethnicity and age, according to Irbaz Bin Riaz, MD, MS, PhD, research fellow in oncology Dana-Farber Cancer Institute and clinical informatics fellow at Mass General Brigham.
“Black men are twice as likely as white men to be diagnosed with prostate cancer, significantly more likely to develop cancer recurrence and metastasis, and two to three times more likely to die of prostate cancer,” he told Healio.
NIH and FDA have issued mandates that emphasize inclusion of historically underserved populations and older patients in clinical trials, in addition to reporting of demographic characteristics to help track disparities in outcomes, he added.
“However, the extent to which these mandates are followed is not well known, and assessing their impact on minority recruitment in modern clinical trials is essential,” Riaz said. “The objective of [our] study was to assess reporting and enrollment disparity by racial, ethnic and age-related subgroups across prostate cancer clinical trials while accounting for baseline incidence.”
Methodology
Riaz and colleagues used publicly available data from MEDLINE, Embase and ClinicalTrials.gov to identify all phase 2 and phase 3 prostate cancer clinical trials reported through February 2021.
Investigators included all randomized global trials as part of the age disparity analysis, whereas the racial/ethnic disparity analysis included only patients from the United States.
Researchers used NCI’s SEER database estimates of population-based prostate cancer incidence for racial and ethnic subgroups. They used global population-based estimates of prostate cancer incidence from the Global Burden of Disease database for the age disparity analysis, and enrollment incidence ratios (EIRs) to assess disparities in enrollment of each subgroup.
Key findings
The investigators found 65 U.S.-based clinical trials eligible for the race and ethnicity analysis, 45 (69.2%) of which reported participants’ race. Only nine trials (13.8%) reported data across all five racial categories.
The proportion of trials that reported data for individual races included:
- 13.8% (n = 9) for Pacific Islander;
- 15.4% (n = 10) for American Indian/Alaska Native;
- 30.8% (n = 20) for Asian; and
- 58.5% (n = 38) for Black/African American.
Seventeen trials (26.2%) reported ethnicity data on Hispanic vs. non-Hispanic patients, and no trial reported outcomes based on ethnicity.
Among the 9,552 participants in trials reporting race, 10.8% were Black and 1.5% were Asian/Pacific Islander.
Meta-analysis of racial representation in prostate cancer trials showed significant underrepresentation of Asian/Pacific Islander patients (EIR = 0.48; 95% CI, 0.34-0.66) and Black patients (EIR = 0.7; 95% CI, 0.59-0.83). A similar analysis for ethnicity showed significant underrepresentation of Hispanic patients (EIR = 0.62; 95% CI, 0.42-0.9).
Of 286 global trials induced in the age-based analysis, 75 (26.2%) reported the enrollment proportion of older adults. Investigators found no disparities in older adult representation among 49 trials that included subgroups categorizing patients as younger or older than age 65 years (EIR = 1; 95%CI, 0.95-1.05).
Clinical implications
Results of the meta-analysis showed “persistent underrepresentation of racial and ethnic minorities in prostate cancer clinical trials,” Riaz said. The gap is evident even after adjusting for estimates of prostate cancer incidence among historically underserved populations, he added.
Representation among Black patients has remained consistently low over time and appeared to be worse in larger trials, Riaz told Healio.
“The fact that there is a significant underrepresentation of minority subgroups in prostate cancer clinical trials, coupled with suboptimal reporting of clinical outcomes by race/ethnicity, is an alarming indication of our collective failure to account for differential health outcomes in our vulnerable populations,” he said. “These results suggest a crucial need to ensure equitable enrollment in clinical trials, as it is fundamental to promoting health equity.”
For more i nformation :
Irbaz Bin Riaz, MD, MS, PhD, can be reached at Dana-Farber Cancer Institute, Harvard Medical School, 450 Brookline Ave., Boston, MA 02215; email: irbazb_riaz@dfci.harvard.edu.
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