Amid Debate Over Diversity, RCC Trials Still Struggle to Reflect Patient Populations

Clinical trials should reflect the patient groups that will use the drugs—at least that’s been the goal for years at the National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO). Until a few weeks ago, it was FDA’s stated policy as well. But the agency’s draft guidance on achieving clinical trial diversity was removed from the website January 23, 2025, and its status is unclear.

A commitment to shrinking disparities was alive and well at the ASCO Genitourinary Cancers Symposium (ASCO GU), held February 13-15, 2025, in San Francisco, California. At least 22 abstracts specifically addressed disparities or health equity, and many more talks or presentations mentioned these issues.

Highlighted here are abstracts that address ongoing struggles to address clinical trial diversity in renal cell carcinoma (RCC), a disease known to affect patients of color at higher rates. Meanwhile, in Europe, where clinical trials have historically been less diverse, an abstract from France suggests investigators are at least starting to collect disparities data.

A Disease Linked to Poverty Is Studied in Wealthy Countries

Regina Barragan-Carrillo, MD | Image: Photo provided by ASCO

Advances in the care of patients with metastatic RCC has raised overall survival 4-fold in the last 20 years.¹ As City of Hope’s Regina Barragan-Carrillo, MD, writes in this abstract, without clinical trials, there are no new drugs or diagnostic tools. The problem in RCC, however, is that in a disease inextricably associated with poverty, trials are largely located in the richest countries and out of reach for the world’s poor.²

In an interview with The American Journal of Managed Care^®, Barragan-Carrillo, a postdoctoral fellow in the Genitourinary Clinic, said this trend occurs while RCC is strongly connected to poverty. “We know that lower socioeconomic status is linked to both a higher risk for developing renal cell carcinoma and also worse survival outcomes. And these survival outcomes are dependent on later diagnosis and worse access to care, as well as less access also to novel systemic therapy.” (For full interview, visit here.)

In the United States, for example, she said, “Black patients [with RCC] have a 16% higher mortality rate compared with their non-Hispanic White counterparts.”

When trials occur only in high-income countries—and when lower-income patients only have access to late-phase trials—this means it takes longer for these patients to gain access to novel therapies, Barragan-Carillo explained.

Methods. Barragan-Carrillo and her colleagues used the National Clinical Trials database to identify all trials for RCC from June 1, 2019, through June 1, 2014. Excluding noninterventional and pediatric studies, they recorded trials with at least 1 active site and then stratified them into categories using World Bank Rankings: high income, upper middle income, lower middle income, and low income. The team used a number of descriptors for each trial, including RCC type, sponsor, phase, and end points, and evaluated trial availability based on factors that included the country’s health expenditures and gross national income.

Results. The median number of countries per trial was 2.6, with 76% taking place entirely in high-income countries; 23% were in upper-middle-income countries, 3% in lower-middle-income countries, and lower-income countries had none. Trials outside high-income countries were typically funded by pharmaceutical companies vs academia (64% vs 40%) and were part of multinational trials (45% vs 16%). Investigators found that trials outside high-income countries were largely late-phase trials (25% vs 8%).

Investigators wrote that a country’s gross national income, health expenditures, and mortality rates were “significantly associated with the number of clinical trials in a country.”

Implications. What happens when only wealthy nations have access to clinical trials?

“The broader implications are quite concerning,” Barragan-Carrillo said. Ultimately, it could mean less innovation if fewer resources are available to study diverse populations, because that makes it harder to develop effective global treatment strategies, she said.

“This could lead to worse patient outcomes. If trials only happen in wealthy regions, we'll continue to see major inequities in who benefits from scientific answers. It leads to a weaker international collaboration, which not only has an impact in health care, but also an economic and social impact.”

Diversity—and Data—Fall Short in Postpandemic RCC Clinical Trials

Bruno R. Bastos, MD | Image: Mount Sinai photo

An abstract presented during ASCO GU by investigators from Mount Sinai Comprehensive Cancer Center shows how much work is needed in to enroll diverse patient populations. Led by Bruno R. Bastos, MD, the study evaluated clinical trial enrollment in 5 major studies in RCC that started after the COVID-19 pandemic: CheckMate 9ER, CLEAR, KEYNOTE 564, LITESPARK 005, and TIVO-3. Investigators planned to analyze each trial by race and compare trial participation rates with Surveillance, Epidemiology, and End Results (SEER) data on RCC incidence.

Results. The authors reported that from 2020 to 2024, a total of 2940 patients enrolled in the 5 industry-sponsored trials; each resulted in FDA approval of a new agent or indication in RCC. The Mount Sinai team sought data on participation rates for White, Black, Asian, and Hispanic patients to compare with SEER data. Authors reported that 3 trials, KEYNOTE 564, LITESPARK-005, and TIVO-3, reported data, “but only 2, KEYNOTE-564 and LITESPARK-005, provided information beyond White participants, including Black and Asian populations. No data on Hispanic participation was reported.”

The authors found that in the 3 trials that did offer data, 88% of the participants were White, which significantly overrepresents the 18.34% share of White patients in the RCC population in the United States. In the 2 trials with more comprehensive data, Black patients represented only 1.2% of the trial participants, falling far short of the 19.67% share of patients they represent in the RCC population. Asian participation, at 11.6%, came closest to their share of the RCC population, which is 8.6%.

“The underrepresentation of minority groups (particularly Blacks and Hispanics) in FDA-approved clinical trials for renal cell carcinoma remains a significant concern in the post-COVID-19 landscape,” the authors wrote. “Addressing these disparities necessitated the implementation of policies that enhance data collection and standardize ethnic classification. Additionally, international collaborative trials should prioritize distinct data reporting for US participants, utilizing NCI SEER nomenclature for consistency.”

French RCC Data: Race Matters, but It’s Not the Whole Story

Looking at health care data by race to identify disparities is so common in the United States that the recent removal of such publicly collected data was contested in court. But in Europe, this is unexplored territory, and it’s becoming an area of greater concern as populations on the European continent become more diverse.

During Saturday’s rapid oral abstract session, Xiaofan Lu, PhD, of Institut de Genétique, Biologie Moléculaire et Cellulaire (IGBMC) in Illkirch, France, presented results from a retrospective cohort study of renal cell carcinoma (RCC) data from database covering 30 French kidney cancer centers, covering a 67-year period from 1957 through 2024. The mission was to analyze 9404 patients—9066 non-White patients and 338 Black patients—with confirmed histology to learn patterns of histology distribution, clinical and tumor features, and outcomes. Results showed the following:

• Clear cell RCC was more prevalent among non-Black patients (68.8% vs 47.6%), for an OR of 2.4 (P < .001).
• Non–clear cell RCC histologies were more common among Black patients including papillary RCC (23.1% vs 11.8%) (P < .001).
• Black patients were younger at diagnosis and more likely to have early-stage tumors with higher rates of nephrectomy.
• No significant differences were seen in cancer-specific survival, but Black patients had better distant recurrence-free survival (HR, 0.55; P = .02).

The analysis shared some good news: Unlike the United States, where links between race and poorer outcomes are seen in multiple disease states, in a universal health system, the authors concluded that “Race does not independently predict clinical outcomes of patients with RCC.”

However, the authors cautioned, “Our binary racial categorization might mask potential disparities between Black patients and patients from other racial backgrounds.”

And while non–clear cell histologies were more common among Black patients, the limited number of overall cases made it difficult to power for disparities.

The results, Lu said, “indicate the need for tailored diagnostic approaches, and equal access to the health care system to minimize the outcome disparities for patients.”

References

1. Young M, Jackson-Spence F, Beltran L, et al. Renal cell carcinoma. Lancet. 2024;404(10451):476-491. doi:10.1016/S0140-6736(24)00917-6.
2. Barragan-Carrillo R. Zugman M, Castro DV, et al. Assessing global disparities in clinical trial availability for renal cell carcinoma. J Clin Oncol. 2025;43(suppl 5):Abstract 449. doi:10.1200/JCO.2025.43.5_suppl.449
3. Bastos BR, Schwartz MA, Gligich O, et al. Ethnic disparities in clinical trials for FDA-approved drugs in renal cell carcinoma: an analysis of the post-COVID era (2020-2024). J Clin Oncol 2025;43(suppl 5):Abstract 677. doi:10.1200/JCO.2025.43.5_suppl.677
4. Lu X, Bernhard JC, Audenet F, et al. Racial disparities in renal cell carcinoma histology and outcomes: insights from the French Kidney Cancer Research Network. J Clin Oncol. 2025;43(suppl 5):Abstract 442. doi:10.1200/JCO.2025.43.5_suppl.442