Mp70-16 Females With Bladder Cancer Are Underrepresented in Clinical Trials in the United States

You have accessJournal of UrologyDiversity, Equity & Inclusion: Health Equity & Outcomes III (MP70)1 May 2024MP70-16 FEMALES WITH BLADDER CANCER ARE UNDERREPRESENTED IN CLINICAL TRIALS IN THE UNITED STATES Amanda A. Myers, Alexis R. Steinmetz, Valentina Grajales, Kelly K. Bree, Zhigang Duan, Lydia Makaraoff, and Ashish M. Kamat Amanda A. MyersAmanda A. Myers , Alexis R. SteinmetzAlexis R. Steinmetz , Valentina GrajalesValentina Grajales , Kelly K. BreeKelly K. Bree , Zhigang DuanZhigang Duan , Lydia MakaraoffLydia Makaraoff , and Ashish M. KamatAshish M. Kamat View All Author Informationhttps://doi.org/10.1097/01.JU.0001008796.84999.75.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Data regarding equitable sex-based enrollment in bladder cancer (BC) clinical trials is conflicting. Population studies have reported varying degrees of both over- and under- representation of females in trials. A limitation of these data is that many trials, especially in metastatic disease, include patients with both BC and UTUC, which have significantly different sex-based incidences. Thus, we evaluated rates of female enrollment in clinical trials of BC while adjusting for UTUC. METHODS: We queried ClinicalTrials.gov for completed phase II and III clinical trials in BC between January 2000 and July 2023. We studied the inclusion criteria, descriptions, and results of each study. We excluded trials conducted outside of the United States or that included other cancer types. We reported trials inclusive of UTUC separately. To assess female enrollment, we used the ratio of observed females enrolled in trials divided by the expected number of females calculated from SEER data. A ratio greater than 1 denotes overrepresentation and a ratio less than 1 denotes underrepresentation of females. We used the incidence of BC (24.1%) from 2010, which was the weighted mean enrollment start year of the included trials. RESULTS: Sixty-two studies met the inclusion criteria. Of these, 31 included UTUC, but all lacked site-specific sex data, so they were analyzed separately. Thus, the primary analysis comprised trials exclusive to BC (n=31). 1982 patients participated in BC trials, with females accounting for 364 (18%). Using the percent of BC patients that were female according to 2010 SEER incidence (24.1%), we calculated a ratio of 0.76 which indicates underrepresentation. This ratio persisted when we used the median percent incidence during 2000-2019 (24.7%) as well as the complete prevalence data (24.4%). The ratios were 0.69 for NMIBC trials and 0.86 for MIBC/mUC trials. Higher female enrollment was observed in UTUC-inclusive trials (Table 1). CONCLUSIONS: Over the past two decades in the United States, females have been underrepresented in BC clinical trials. This inequity is worrisome in light of evidence of significant sex-based differences in both BC biology and treatment outcomes. Efforts to increase the enrollment of females is paramount to improving disparate outcomes and ensuring equity in our care delivery to BC patients. Source of Funding: N/A © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1135 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Amanda A. Myers More articles by this author Alexis R. Steinmetz More articles by this author Valentina Grajales More articles by this author Kelly K. Bree More articles by this author Zhigang Duan More articles by this author Lydia Makaraoff More articles by this author Ashish M. Kamat More articles by this author Expand All Advertisement PDF downloadLoading ...