AN EVALUATION OF RACE, ETHNICITY, AGE, AND GENDER-BASED REPRESENTATION IN PHASE I-II RENAL CELL CARCINOMA CLINICAL TRIALS IN THE UNITED STATES

You have accessJournal of UrologyKidney Cancer: Advanced (including Drug Therapy) I1 Apr 2018PD24-06 AN EVALUATION OF RACE, ETHNICITY, AGE, AND GENDER-BASED REPRESENTATION IN PHASE I-II RENAL CELL CARCINOMA CLINICAL TRIALS IN THE UNITED STATES Alain Kaldany, Kyle Blum, David Paulucci, Isuru Jayaratna, John Sfakianos, and Ketan Badani Alain KaldanyAlain Kaldany More articles by this author , Kyle BlumKyle Blum More articles by this author , David PaulucciDavid Paulucci More articles by this author , Isuru JayaratnaIsuru Jayaratna More articles by this author , John SfakianosJohn Sfakianos More articles by this author , and Ketan BadaniKetan Badani More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.1199AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Enrollment of a representative population permits generalizable and reliable results from clinical trials. We therefore sought to evaluate whether patients enrolled in trials for advanced renal cell carcinoma (RCC) in the US is representative of the overall population of advanced RCC patients in the nation. METHODS The clinicaltrials.gov database was queried for interventional clinical trials directed at clinically advanced (stage III/IV) RCC that enrolled patients from only the US. We identified 375 patients from 18 Phase I-II trials that met eligibility criteria. The American College of Surgeons’ National Cancer Database (NCDB) which includes data on approximately 70% of all US cancer diagnoses was queried and we identified 75,308 patients with advanced (stage III/IV) RCC. Demographic characteristics were summarized and compared between the two populations. RESULTS Compared to the US population of advanced RCC (NCDB), significant under-representation in clinical trials was observed for patients aged 65+ (50.4% vs. 26.3%; p<0.001) and among those with Hispanic ethnicity (7.2% vs. 2.7%; p=0.005). Black patients (7.0% vs. 9.8%, p=0.076), white patients (89.9% vs. 87.0%, p=0.107), and other racial groups (p>0.05) were well represented. Female patients made up 30.3% of trial enrollees and 33.3% of the advanced RCC population (p=0.221). CONCLUSIONS Significant under-representation was observed for elderly and Hispanic patients, however black race and female gender were appropriately represented in Phase I-II RCC clinical trials. Greater efforts to include under-represented populations are necessary to improve the effectiveness and generalizability of clinical trials in kidney cancer. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e488 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Alain Kaldany More articles by this author Kyle Blum More articles by this author David Paulucci More articles by this author Isuru Jayaratna More articles by this author John Sfakianos More articles by this author Ketan Badani More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...