FDA analysis: Demographic trends in bladder and renal cancer trials.
e18144 Background: Many publications report under representation of minorities in certain subgroups, which may limit the generalizability of clinical trial (CT) results. This analysis, investigates and reports enrollment trends in CTs submitted between 2006-2017 in support of marketing applications for drugs indicated for the treatment of urothelial (UC) and renal cancer carcinoma (RCC), and compares them to incidence rates of these diseases by Surveillance, Epidemiology, and End Results (SEER) registry and the US census bureau. Methods: We identified all marketing applications for the treatment of UC and RCC that provided the primary evidence of safety and efficacy and aggregated the demographic data across trials and disease. Using these two pooled datasets, we compared the patient proportions enrolled in each of the race, sex and age categories to the corresponding rates in US cancer population estimated based on the corresponding incidence rates reported by SEER and the US census bureau using a Chi-squared test. Results: The pooled seven UC and 14 RCC CTs provided 2035 and 6757 patients respectively. The results are summarized below for the 939 (46%) UC and 1489 (22%) RCC patients enrolled in the US. Conclusions: Our findings indicate that majority of the patients were enrolled outside of the US. There were lower proportion of Black patients (4% vs 8%), older patients, age ≥ 75 years (30% vs 48%) and males (74% vs 80%) enrolled in UC population in the US. Higher proportions were observed in both White (89% vs 85%) and Asian (4% vs 2%) patients in UC and in White (90% vs 79%) patients in RCC.[Table: see text]