Year: 2025
Type: article
Abstract: Background Clinical trials are the cornerstone for generating high-quality evidence to improve patient outcomes. In metastatic renal cell carcinoma (RCC), research over the past two decades has resulted in a fourfold increase in median overall survival (Lancet, 2024). However, most clinical trials are conducted in high-income countries (HICs), limiting the inclusion of diverse patient populations (JCO CCI, 2020). We aimed to assess the global distribution of RCC clinical trials and identify disparities by country income level. Methods We queried the National Clinical Trials database for all trials enrolling patients with RCC between June 1, 2019, and June 1, 2024. We excluded non-interventional studies, pediatric trials, and trials for non-RCC malignancies. Participating countries were categorized using the World Bank Ranking (WBR): high-income (HICs), upper-middle-income (UMICs), lower-middle-income (LMICs), and low-income countries (LICs). For each eligible trial, we documented RCC subtype, sponsor, trial phase, disease stage, and multinational status. Descriptive statistics were used to summarize trial characteristics. We assessed the association between country income level and trial availability using the Kruskal-Wallis test and Poisson regression to evaluate associations with RCC incidence, mortality, WBR, health expenditure, and gross national income (GNI). Results A total of 357 eligible trials were identified. Most (N = 273; 76%) were conducted exclusively in HICs, while only 84 trials (24%) included participation from UMICs, LMICs, or LICs. There were no significant differences in RCC subtype or disease stage across income groups. Pharmaceutical-sponsored trials were more common in non-HICs compared to HICs (64.3% vs. 39.6%, P < .001), whereas government and academic-sponsored trials were more frequent in HICs (60.4% vs. 35.7%, P < .001). Although early-phase trials predominated in all regions, late-phase trials were more common in non-HICs (25% vs. 8.1%, P < .001). Multinational trials were significantly more prevalent in non-HICs (45.2% vs. 15.8%, P < .001). The odds of having an RCC trial available significantly decreased with lower income classification (OR: UMICs 0.20; LMICs 0.05; LICs 0.013 vs. HICs). Poisson regression showed that GNI, health expenditure, and mortality were significantly associated with the number of clinical trials per country. Conclusions RCC clinical trials are largely concentrated in high-income countries, with limited inclusion of UMICs, LMICs, and LICs. Countries outside the HIC group are more reliant on pharmaceutical industry funding and international collaborations to access clinical research. Addressing these disparities by expanding clinical trial access in non-HICs is essential to promote global equity in RCC care and ensure the generalizability of trial findings across diverse populations.
Source: The Oncologist
Authors: Ruchi Agarwal, Jaya Goud, Miguel Zugman, Daniela Castro, Xiaochen Li, Koral Shah, Lily Lau, Aaron Lee, Salvador Jaime-Casas, Hedyeh Ebrahimi, Gabriela Regalado-Porras, Sharon Choi, Nora Sobrevilla-Moreno, Erika Ruiz-Garcia, Shivanee Kooner, Skylar Reid, Nasr Chaudhary, Rana McKay, Sumanta Pal, Regina Barragan-Carrillo
Institutions: University of Pennsylvania, City Of Hope National Medical Center, City of Hope, University of California, Irvine, University of California, Berkeley, Centro Médico ABC, University of California San Diego, Instituto Nacional de Cancerología, University of Southern California, Rensselaer Polytechnic Institute, University of California, Merced
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,852
OpenAlex ID: W4414992718
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