MP34-11 RACIAL DISPARITIES IN GENITOURINARY ONCOLOGY TRIALS: A 15 YEAR REVIEW

Abstract

You have accessJournal of UrologyHealth Services Research: Quality Improvement & Patient Safety II (MP34)1 Sep 2021MP34-11 RACIAL DISPARITIES IN GENITOURINARY ONCOLOGY TRIALS: A 15 YEAR REVIEW Igor Inoyatov, Syed Rahman, Spencer Mossack, Varun Talanki, Sophia Jacob, James Rail, and David M Golombos Igor InoyatovIgor Inoyatov More articles by this author , Syed RahmanSyed Rahman More articles by this author , Spencer MossackSpencer Mossack More articles by this author , Varun TalankiVarun Talanki More articles by this author , Sophia JacobSophia Jacob More articles by this author , James RailJames Rail More articles by this author , and David M GolombosDavid M Golombos More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002043.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Historically minority groups, for unclear reasons, have been underrepresented in oncology clinical trials. In 1993 the Health Revitalization Act mandated guidelines for minority inclusion in NIH funded research. This was later amended with a requirement for trials to submit results by race. Limited information is available regarding the enrollment of minorities in urologic oncology trials. We sought to evaluate the enrollment rates of minority patients in advanced prostate, kidney and bladder cancer drug trials. METHODS: The ClinicalTrials.Gov database was queried for the most recent prostate, kidney and bladder cancer medical trials. Pivotal clinical trials which lead to the FDA approval of medical therapies in the advanced disease setting from 2006 until present were analyzed. Minority groups were defined as African-American and Hispanic patients. RESULTS: 15 clinical trials across the three various types of genitourinary malignancies were analyzed. Four trials were identified for prostate cancer, six for bladder cancer and five for kidney cancer (Table 1). For advanced prostate cancer 3/4 (75%) trials reported information regarding minority groups of which two trials (TITAN and PREVAIL) reported information on African-Americans. A combined total of 2242 patients were enrolled into these two trials of which 45 (2%) patients were identified as African-American. For advanced bladder cancer 4/6 (67%) trials reported information regarding minority groups, with African-Americans representing <5% of patients enrolled. Of the three trials analyzed in advanced kidney cancer with available minority reporting, African-Americans represented between 1% to 3% of the population. Enrollment information was only available in for Hispanics in 1/14 (8%) of trials analyzed. CONCLUSIONS: The majority of the pivotal clinical trials for genitourinary cancer therapies failed to report enrollment information regarding minorities. Of the trials which did report, enrollment remained low with the majority of trials enrolling < 3%. This is especially concerning for prostate cancer trials considering African-American males are at higher risk for lethal disease. The urologic oncology community should continue to emphasize the importance of adequately representing minority populations in clinical trials as well as reporting these numbers. Source of Funding: NA © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e620-e620 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Igor Inoyatov More articles by this author Syed Rahman More articles by this author Spencer Mossack More articles by this author Varun Talanki More articles by this author Sophia Jacob More articles by this author James Rail More articles by this author David M Golombos More articles by this author Expand All Advertisement Loading ...