Assessment of racial and ethnic reporting in clinical trials cited by the NCCN bladder cancer treatment guidelines.

Abstract

e23125 Background: Clinical trials cited in national treatment guidelines are standard references of care. However, the extent to which these trials report racial and ethnic participant demographics remains unclear. We evaluated racial and ethnic reporting and representation in interventional clinical trials cited within the NCCN Bladder Cancer Guidelines. Methods: All references cited in the NCCN Bladder Cancer Guidelines (Version 3.2025) were reviewed. Only randomized controlled trials were included. Race and ethnicity reporting was assessed based on baseline demographic data reported in each study. Trials were categorized by publication year and further subclassified to predefined time blocks (1980–1999, 2000–2004, 2005–2009, 2010–2014, 2015–2019, and 2020–2024). Trials were also classified as U.S.-based versus non-U.S.-based. Temporal trends and subgroup comparisons were evaluated using Fisher exact testing, as provided by the biostatistical analysis. Results: Among 346 NCCN-cited references, 133 (38.4%) were randomized controlled trials. Overall, 33 trials (24.8%) reported race or ethnicity. Among trials with available publication-year stratification (n = 81), race reporting increased significantly over time, from 0% in trials published before 2000 to 65% in trials published between 2020 and 2024 (p = 0.0012). Trials published after 2015 were significantly more likely to report race compared with earlier periods (p < 0.01). U.S.-based trials demonstrated higher rates of race reporting than non-U.S.-based trials, although this difference was not consistently statistically significant across all comparisons. Among trials reporting race, participants were predominantly White (72.9%), with lower representation of Asian (13.6%), Black (2.6%), Hispanic (0.2%), American Indian/Alaska Native (0.2%), Native Hawaiian/Pacific Islander (0.1%), and multiracial participants (6.4%). Conclusions: Less than half of the trials cited in the NCCN Bladder Cancer Guidelines report racial or ethnic participant data, although reporting has improved significantly in recent decades. When reported, trial populations remain predominantly White, with limited representation of historically underrepresented racial and ethnic groups. There is a need for standardized reporting of race and ethnicity in bladder cancer clinical trials to ensure that guidelines apply to all patient populations.