Race and Ethnicity Representation in Phase 2/3 Oncology Clinical Trial Publications: A Systematic Review.

Importance: The five 1997 Office of Management and Budget races in the US include American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White, with Hispanic ethnicity. Despite the Affordable Care Act mandating Office of Management and Budget-based collecting and reporting standards, race and ethnicity publishing in medical journals is inconsistent, despite being necessary to achieve health equity. Objective: To quantify race and ethnicity reporting rates and calculate representation quotients (RQs) in published oncology clinical trials. Evidence Review: In this systematic review, PubMed and Embase were queried for phase 2/3 clinical trials of the 6 most common noncutaneous solid cancers, published between January 1, 2012, and December 31, 2022, in 4 high-impact journals. Trial characteristics were recorded. The RQs for each race and ethnicity were calculated by dividing the percent of representation in each clinical trial publication by the percent of year-matched, site-specific incident cancers in the US, compared with Kruskal-Wallis tests with Bonferroni correction (BC). Reporting was compared between journal publications and ClinicalTrials.gov. Findings: Among 1202 publications evaluated, 364 met inclusion criteria: 16 JAMA, 241 Journal of Clinical Oncology, 19 Lancet, and 88 New England Journal of Medicine. Publications included 268 209 patients (171 132 women [64%]), with a median of 356 (IQR, 131-800) patients per publication. Reported race and ethnicity included American Indian or Alaska Native in 52 (14%) publications, Asian in 196 (54%), Black or African American in 215 (59%), Hispanic in 67 (18%), Native Hawaiian or Other Pacific Islander in 28 (8%), and White in 254 (70%). Median RQ varied across race (P < .001 BC), with 1.04 (IQR, 0.09-4.77) for Asian, 0.98 (IQR, 0.86-1.06) for White, 0.42 (IQR, 0.12-0.75) for Black or African American, and 0.00 (IQR, 0.00-0.00) for both American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander patients. Sensitivity analyses showed similar findings on subset analysis for US-only clinical trials. There was significantly less race and ethnicity reporting in the clinical trial publications compared with ClinicalTrials.gov documentation for American Indian or Alaska Native (14% vs 45%; P < .001 per McNemar χ2 test with continuity correction [MC]) and Native Hawaiian or Other Pacific Islander (8% vs 43%; P < .001 MC). Conclusions and Relevance: While most phase 2/3 oncology clinical trials published in high-impact journals report race and ethnicity, most did not report American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander racial categories. Our findings support a call to action for consistent journal policies and transparent race and ethnicity reporting, in alignment with Affordable Care Act-concordant race and ethnicity federal reporting requirements.

Racial Disparities among Asian American, Native Hawaiian, and Other Pacific Islander Patients with Cancer Who Refuse Recommended Radiation Therapy or Surgery.

Despite radiation therapy (RT) and surgery being the curative treatments, prior work demonstrated that the aggregated Asian American (AA) and Native Hawaiian and Other Pacific Islanders (NHPI) population refuse RT and surgery at a higher rates than other races. Given that AA and NHPI are distinct groups, data disaggregation is necessary to understand racial and ethnic disparities for treatment refusal. We aimed to (1) compare RT and surgery refusal rates between AA and NHPI populations, (2) assess RT and surgery refusal on overall mortality, and (3) determine predictors of refusing RT and surgery using the United States (U.S.) National Cancer Database. Adjusted odds ratios (aOR) and 95% confidence intervals (95%CI) for treatment refusal were calculated using logistic regression. Adjusted hazard ratios (aHR) were calculated for overall survival using Cox proportional hazard models among propensity score-matched groups. The overall rate of RT refusal was 4.8% and surgery refusal was 0.8%. Compared to East AA patients, NHPI patients had the highest risk of both RT refusal (aOR = 1.38, 95%CI = 1.21-1.61) and surgery refusal (aOR = 1.28, 95%CI = 1.00-1.61). RT refusal significantly predicted higher mortality (aHR = 1.17, 95%CI = 1.08-1.27), whereas surgery refusal did not. Predictors of RT and surgery refusal were older patient age, high comorbidity index, and cancer diagnosis between 2011-2017. The results show heterogenous treatment refusal patterns among AA and NHPI populations, suggesting areas for targeted intervention.