Examining Patient Characteristics in Bladder Cancer Clinical Trials Involving Immunotherapy

Background/Objectives: Comprehending the patient composition of bladder cancer (BC) clinical trials is crucial for effectively designing clinical trials and contextualizing the generated science. In this study, we reviewed publicly available data and explored the demographic information of BC studies administering immune checkpoint inhibitors (ICIs). Methods: Trial eligibility was irrespective of government or private sponsorship, and trial activation dates were limited to between 2013 and 2023. The main inclusion criteria were use of ICIs and trials reporting endpoints that include progression-free survival (PFS), overall survival (OS), disease-free survival (DFS), and event-free survival (EFS). The key exclusion terms were review articles and meta-analysis. Results: We identified a total of 109 clinical trials with an aggregate total of 8936 enrolled patients. Ninety-six percent identified as Caucasian or White European, and 23% identified as female. Further analyses revealed that 65% of the patients were aged 65 years or older. One-third of the trials listed similar comorbidities, such as cardiovascular disease and diabetes, that were exhibited by approximately 30 percent of the patients. Conclusions: Our data suggest that recruitment strategies should be mindful of comorbidities that may interfere with ICI treatments. Additionally, our results are consistent with findings from other reviews that indicate that certain patient groups may be under-represented in BC trials.