The following article features coverage from the 2021 Genitourinary Cancers Symposium meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Many genitourinary (GU) cancer trials did not report the race of participants, and among those that did, a disproportionate number of patients were found to be White, indicating a pattern of relative overrepresentation, according to the results of a retrospective review reported at the 2021 Genitourinary Cancers Symposium.1

The researchers reviewed new market authorizations issued from January 2006 to October 2020 in the GU cancer space and identified 42 new licensing indications for 31 different drugs indicated for GU cancers.

The analysis revealed that only 30% of GU cancer registration trials reported race in the 5 years that preceded the United States Food and Drug Administration’s (FDA’s) release of guidance “to provide FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials.”2

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Once the FDA guidance was released in 2016, the proportion of trials that reported race doubled to 60%.

Lead author Mark Lythgoe, MBBS, of Imperial College London in the United Kingdom, said that while race reporting in registration studies has improved since the guidance, it is not yet “universal.”

Findings from the evaluation also showed that most participants enrolled in GU cancer trials were White (69.5%). Only a few were Asian (8.3%), Black (2.0%), Native Hawaiian or Pacific Islander (0.1%), or Alaska Native (0.3%). Race was unknown for 18.0% of participants.

This trend was upheld when trials were analyzed by GU cancer type. White patients made up the majority for prostate cancer (76.4%), urothelial cancer (60.0%), and renal cancer (58.3%) trials. Asian and Black patients made up less than 10% and 3% of each of the 3 trials, respectively.

“The inclusion of Black participants is in particular quite disappointing when compared to the burden of disease in this group,” said Dr Lythgoe. “Therefore, recruitment of black and minority participants should be a research priority.” 

Notably, GU cancers account for 1 in 5 new cancer diagnoses in the US, and have been associated with significant racial disparities in terms of treatment and outcomes. The GU cancer burden is also known to be higher in non-White populations.

Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study.

Read more of our coverage of the 2021 Genitourinary Cancers Symposium by visiting the conference page.


  1. Racial diversity and reporting in FDA registration trials for genitourinary (GU) cancers from 2006-20. Poster presented at: 2021 Genitourinary Cancers Symposium; February 11-13, 2021. Abstract 22.