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Health equity in genitourinary (GU) cancer clinical trials is a critical issue that requires attention. In fact, through the 2023 Consolidated Appropriations Act, lawmakers are requiring the inclusion of diversity plans for all Phase 3 clinical trials with few exceptions, which compliments the FDA’s Diversity in Clinical Trials Initiative. Despite advances in urologic oncology, there are significant gaps in the representation of diverse populations in clinical trials, often affecting the generalizability of trial results and, ultimately, patient care. Let’s examine the current state of health equity in GU cancer clinical trials and the work that needs to be done to close the gap and its potential impact on patient outcomes. 

Current State of Health Equity in GU Cancer Clinical Trials 

Prostate, kidney, and bladder cancers are among the top 10 newly diagnosed cancers and causes of death. Clinical trials play a pivotal role in advancing the understanding and treatment of GU cancers. However, there is a notable lack of representation in these trials. Adequate representation is not limited to racial/ethnic diversity, but also other common social determinants of health. Here are a few examples of how inadequate representation in clinical trials has led to gaps in understanding diseases, conditions, preventions, and the safety and efficacy of treatments.  

• Race/Ethnicity: Historically, clinical trials have been studied in White males. Understanding the molecular differences in disease presentation and progression along with the effectiveness of treatments are not characterized in racially diverse populations. 
• Age: GU cancers often affect the older population than participants who participated in clinical trials for treatment. However, studies are often conducted on younger patients who are fit with no comorbidities. The physiological differences between these populations, as with muscle-invasive bladder cancers, may affect the efficacy data from clinical trials.  
• Sex: Women tend to present with an advanced stage of urothelial cancer compared to men. Despite hematuria being a widely accepted symptom of urothelial cancer, further examination/evaluation to identify the underlying cause deviated from guidelines in women and was mistaken as an infection or nonurological issue. Inadequate representation can mischaracterize the pathophysiology and disease progression and misrepresent the safety, tolerability, and efficacy of treatment between sexes. 

These disparities underscore the need for improved inclusion and representation in clinical trials to ensure that all patient populations benefit from advancements in cancer care to minimize threats to the generalizability of the scientific findings. 

Importance of Adequate Representation 

Adequate representation of diverse patient populations in clinical trials is crucial for several reasons. Firstly, it ensures that the safety and efficacy of treatments are evaluated across different demographic groups, leading to more generalizable results. Secondly, it helps identify potential differences in treatment responses among various populations, ultimately guiding personalized and effective cancer care. Therefore, addressing the underrepresentation of minority groups in GU cancer clinical trials is essential for reducing health disparities and improving patient outcomes. 

FDA's Initiative to Improve Diversity and Representation in Clinical Trials 

The FDA has recognized the importance of diversity and representation in clinical trials and has recently launched initiatives to address these issues. The pursuit of health equity and equality in urologic oncology has been highlighted as a critical area of focus. By promoting the inclusion of underrepresented populations in clinical trials, the FDA aims to enhance the generalizability of trial results and ensure that approved treatments are effective for all patient groups. 

Call to Action: Closing the Gap 

As medicine continues to move towards precision practices, the unique characteristics of individual patients must be accounted for. To close the gap in health equity in GU cancer clinical trials, a concerted effort is needed from the oncology community. Here are five things Oncologists and Researchers can do to support adequate representation in clinical trials:  

1. Engage with and encourage ALL eligible patients with diverse backgrounds to take part in clinical trials. 

2. Evaluate eligibility criteria for clinical trial enrollment including a broader age range by assessing “fit-ness”. 

3. Practice culturally humble approaches to care and recruitment at one’s practice, community events, advocacy groups, and other partnerships. 

4. Explore alternative methods of assessments for protocol-specified visits to reduce travel burdens. 

5. Transparency in reporting demographic data, such as race/ethnicity, age, and geography, in publications and presentations. 

Addressing the gaps in health equity in genitourinary cancer clinical trials is imperative for advancing patient care. With a shift in mindset, prioritizing adequate representation, and supporting initiatives aimed at improving diversity and access in clinical trials, oncologists can contribute to reducing health disparities and enhancing the effectiveness of cancer treatments for all patient populations. 

REFERENCES 

Paravathaneni M, Safa H, Joshi V, et al. 15 years of patient-reported outcomes in clinical trials leading to GU cancer drug approvals: a systematic review on the quality of data reporting and analysis. EClinicalMedicine. 2024;68:102413. doi:10.1016/J.ECLINM.2023.102413. 

Li H, Sahu KK, Kumar SA, et al. Access to care and healthcare quality metrics for patients with advanced genitourinary cancers in rrban versus rural areas. Cancers (Basel). 2023;15(21). doi:10.3390/CANCERS15215171/S1 

Owens-Walton J, Williams C, Rompré-Brodeur A, Pinto PA, Ball MW. Minority enrollment in phase II and III clinical trials in urologic oncology. Journal of Clinical Oncology. 2022;40(14):1583. doi:10.1200/JCO.21.01885 

Hoffman-Censits J, Kanesvaran R, Bangs R, Fashoyin-Aje L, Weinstock C. Breaking barriers: addressing issues of inequality in trial enrollment and clinical outcomes for patients with kidney and bladder cancer. https://doi.org/101200/EDBK_320273. 2021;(41):e174-e181. doi:10.1200/EDBK_320273 

Hoffman-Censits J, Kanesvaran R, Bangs R, Fashoyin-Aje L, Weinstock C. Breaking barriers: addressing issues of inequality in trial enrollment and clinical outcomes for patients with kidney and bladder cancer. https://doi.org/101200/EDBK_320273. 2021;(41):e174-e181. doi:10.1200/EDBK_320273