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Introduction Significant racial disparities in survival outcomes exist among Head and Neck Cancer (HNC) patients. Appropriate racial representation in clinical trials is essential to evaluate whether head and neck cancer (HNC) treatments are effective across diverse populations. Building upon a previous analysis by Zuckerman et al., that reported racial and ethnic disparity in HNC clinical trials, this current study assessed temporal changes in HNC clinical trial enrollment in the context of changing racial and ethnic disease prevalence between 2002 and 2020.
Methods A comprehensive review of clinical trials focusing on HNC from January 2002 to December 2020 yielded 278 initial studies. After applying inclusion and exclusion criteria, 107 eligible trials were analyzed. Participant demographics were categorized into five standardized racial/ethnic groups aligned with the Surveillance, Epidemiology, and End Results (SEER) database classifications. Differences in racial group enrollment rates (as compared to their representation among HNC patients) were investigated using boxplots and scatterplots stratified by race and year, and with multiple linear regression.
Results Significant racial disparities in HNC clinical trials were identified, where White participants were overrepresented and minority groups, including Black (-0.121, 95% CI: -0.145, -0.095), Hispanic (-0.174, 95% CI: -0.199, -0.149), Asian/Pacific Islander (-0.129, 95% CI: -0.155, -0.105), and American Indian/Alaska Native (-0.104, 95% CI: -0.128, -0.079), were consistently underrepresented, with no change in representation over 18 years time period. This suggests that while previous analysis of this data had shown worsening of racial and ethnic diversity over time. This analysis examined these temporal changes in the context of changing disease prevalence, and illustrated stable enrollment proportions over time.
Conclusion This work builds on work by Zuckerman et al. by adjusting for HNC patient demographics and by assessing annual changes in racial representation. This methodology revealed that there was no change in racial HNC trial representation over the last 20 years. It also reinforces the work by Zuckerman et al. by demonstrating that initiatives to ensure equitable representation are not working. In both studies, there was persistent over-representation of white HNC patients in HNC clinical trials. New approaches that facilitate equitable representation are needed to improve the generalizability and effectiveness of HNC treatment outcomes across all demographic groups.
