Evaluating therapeutic bladder cancer trial disparities in race/ethnicity.

Abstract

446 Background: Racial clinical trial disparities in bladder cancer outcomes remains a critical problem in the United States. This study sought to examine representation by race and sex among therapeutic bladder cancer clinical trials that informs the standard of care in bladder cancer management. Methods: Published clinical trial data that inform clinical management were identified from the National Comprehensive Cancer Network guidelines and by clinician input from 2009 to 2021. The characteristics of participants, including sex and race, were collected. Clinical trials were categorized by clinical setting: metastatic bladder cancer (MBC), muscle invasive bladder cancer (MIBC), and non-muscle invasive (NMIBC). Bladder cancer incidence by race were collected from the Surveillance, Epidemiology, and End Results (SEER) Program. SEER incidence data by race was compared to the racial/ethnic breakdown of bladder cancer clinical trial participants and evaluated using hypothesis testing (chi-square). Results: A total of 28 clinical trials were assessed, with a pooled sample of 8003 participants. race was reported for 1786 participants. A total of 17 clinical trials did not report race. The population data from SEER details bladder cancer distributions as 89.52% White, 5.80% Black, 0.33% American Indian/Alaska Native, and 4.36% Asian or Pacific Islander. Chi-square analysis demonstrated significant differences in racial representation for MBC (p< 0.0001) and NMIBC (p=0.0423) settings. No significant differences were observed in the MIBC (p= 0.1954) setting. Conclusions: This study observed that the distributions of race in MBC and NMIBC clinical trials are different from that of the population affected by bladder cancer. It is imperative for therapeutic cancer clinical trials to achieve adequate representation to ensure standard of care therapies in bladder cancer management benefits all.[Table: see text]