AUA 2018: An Evaluation of Race, Ethnicity, Age, and Gender-Based Representation in Phase 1-11 Renal Cell Carcinoma Clinical Trials in the United States

San Francisco, CA ( In this study the authors evaluated whether patients enrolled in trials for advanced renal cell carcinoma (RCC) in the US are representative of the overall population of advanced RCC patients in the nation.

The database was queried for interventional clinical trials directed at clinically advanced (stage III/IV) RCC that enrolled patients from only the US. A total of 375 patients from 18 Phase I-II trials that met eligibility criteria were identified. The American College of Surgeons’ National Cancer Database (NCDB) which includes data on approximately 70% of all US cancer diagnoses was queried and overall a total of 75,308 patients with advanced (stage III/IV) RCC were identified. These two populations were compared in (Table 1).

DemographicCharacteristics AdvancedRCC

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=0.05). Female patients made up 30.3% of trial enrollees and 33.3% of the advanced RCC population (p=0.221).

The limitations reported by the authors include the relatively smaller number of patients in the clinical trials cohort compared to the NCDB cohort, and the hospital-based differences in patient populations between clinical trial sites and NCDB cancer centers.

In conclusion, 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.

Presented by: Alain Kaldany, New York, NY, USA
Co-Authors: Kyle Blum, David Paulucci, Isuru Jayaratna, John Sfakianos, Ketan Badani, New York, NY

Written by:  Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA