Dr Shah on Disparities in Worldwide Bladder Cancer Trial Availability

Koral Shah, MD, details the rationale of evaluating worldwide disparities in bladder cancer clinical trial availability.

“My main aim for researching was [detailing] the worldwide distribution of global clinical trials in bladder cancer, but specifically learning about clinical trial characteristics. I specifically wanted to look at a country's income classification or world bank ranking and [assess] how that associates with having a bladder cancer trial, or how that association affects the different clinical trial characteristics that are available.”

Koral Shah, MD, fellow, Hematology & Medical Oncology, City of Hope, details the rationale behind evaluating worldwide disparities in clinical trial availability in bladder cancer.

Associations between a country’s income classification and available bladder cancer trials were assessed to determine different clinical trial characteristics, Shah begins. The rationale for this research lies in the disparities in bladder cancer trials, she notes. Specifically, there are more trials in higher-income countries compared with lower-income countries, she explains. According to data from the global observatory cancer database from 2022, 90% of the top 10 countries with the highest incidence of bladder cancer were high-income countries, Shah emphasizes. In contrast, she adds that the top 10 countries with the highest mortality rates included 60% of non–high-income countries.

Of note, the majority of countries in the initial query (64.6%) did not have available bladder cancer trials, with 60.9% of these including low-income or lower middle–income countries. Lower availability of trials was seen in upper middle–income, lower middle–income, and low-income countries, with respective odds ratios of 0.34 (P = .01), 0.08 (P < .001), and 0.01 (P = .001). Findings showed that early phase bladder cancer trials were predominantly set in high-income countries, which opened a gap in efficacy and safety testing for diverse populations.

In 2024, ASCO also released a policy statement that underscored the need for global equity in clinical trials, which included addressing several unmet needs, Shah says. These included barriers related to patients and providers, and government and regulatory entities. Therefore, evaluating the current status of bladder cancer trials worldwide was necessary to identify where disparities continue to lie and potential improvements to push for equitable care in bladder cancer, Shah concludes.