ARE WOMEN UNDERREPRESENTED IN UROLOGIC ONCOLOGY CLINICAL TRIALS?

Abstract

Introduction

Clinical trials should reflect the population affected by the disease under study. While urologic cancers occur more frequently in men, there is still a significant incidence in women. Whether women are proportionately represented in urologic oncology clinical trials is not known. Ensuring representative enrollment is crucial for the generalizability of trial outcomes and addressing potential gender disparities in treatment efficacy and safety. This analysis examines enrollment of women in urologic oncology clinical trials compared to the estimated incidence of these cancers among women.

Methods

Enrollment demographics were extracted from the Aggregate Analysis of ClinicalTrials.gov database for bladder and kidney cancer trials registered since 1/1/2007. Trials with results reported were included. The proportion of female enrollees in each trial was calculated from aggregate result tables. Trials were then coded by cancer type, and descriptive statistics were calculated for proportion of women enrolled for trials of each cancer type. These proportions were compared to the proportion of incident cancers estimated by the American Cancer Society.

Results

There were 590 cancer trials included in the analysis, with 414 kidney and 176 bladder trials. The median proportion of women in kidney cancer trials was 29% (IQR 23-37%), with a mean of 31%. The expected proportion based on estimated proportional incidence of kidney cancer in women is 36%. Among bladder cancer trials, the median proportion of women was 22% (IQR 16-30%), with a mean of 25%, which is similar to the estimated proportional incidence of bladder cancer in women (24%).

Conclusions

The proportion of women enrolled in kidney cancer clinical trials is below what is expected based on annual incident proportions, falling short by approximately 1 in 14 women with kidney cancer. Meanwhile, bladder cancer trials enrolled the expected proportion of women with bladder cancer. Further work is needed to ensure adequate representation of women in kidney cancer trials, especially for advanced and metastatic settings. While women are not currently underserved in bladder cancer trials, efforts should continue to maintain representative enrollment of women to ensure equitable and effective urologic cancer treatment across sexes and genders.