Racial, ethnic, and socioeconomic disparities in clinical trial reporting for metastatic spine tumors: An exploration of North American studies.

purposeThe objective of this study was to evaluate the reporting of racial, ethnic, and socioeconomic data in clinical trials exploring the management of metastatic spine disease (MSD).

methodsWe undertook a cross-sectional analysis of North American completed and published clinical trials registered on ClinicalTrials.gov exploring the management of patients with MSD. Data on patient demographics, trial characteristics, reporting of race and ethnicity, distribution of racial and ethnic groups, and reporting of socioeconomic measures was extracted from ClinicalTrials.gov and related publications identified through PubMed and Google Scholar searches. An exploratory data analysis was performed, followed by Pearson's Chi-square and binary logistic regression analyses to explore associations of covariates with racioethnic reporting.

resultsOut of 158 completed trials, only 8% (12 of 158) met inclusion criteria with published results. These 12 trials included a total of 1,568 patients with a mean age of 61 years. Almost half (42%; (5 of 12)) of trials did not report race, while only 17% (2 of 12) of trials reported ethnicity. In trials reporting complete racial data (n = 5), 77% (377 of 493) patients were White, 15% (n = 73) Black or African American, and 4% (n = 19) Asian. American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander patients were severely underrepresented (0.4% and 0.2%, respectively). Of the two trials reporting ethnicity, 94% (479 of 514) patients were Not Hispanic or Latino. Sponsoring body of the trial, trial phase, intervention type, number of trial patients, or mean age of patients were not significantly associated with racioethnic reporting. Notably, no trial reported any measures of socioeconomic status.

conclusionOur review revealed significant gaps in the reporting of racial, ethnic, and socioeconomic data in MSD clinical trials, with substantial underrepresentation of minority groups. This underrepresentation limits the generalizability of trial findings and may perpetuate health disparities. Coordinated efforts from researchers, clinicians, policymakers, and funding bodies are needed to improve diversity in future trials. Strategies such as targeted outreach, community engagement, and more inclusive eligibility criteria should be implemented to ensure that trial populations better reflect the diversity of MSD patients in the general population.