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Updated: Dec 13, 2025
Direct Drug Delivery to Kidney via the Renal Artery
Published on: April 17, 2021
The global landscape of drug development for kidney cancer
D Trapani1, G Curigliano1, Eniu Alexandru2
1Department of Oncology and Hemato-Oncology, University of Milano, Milano, Italy; European Institute of Oncology, IRCCS, Milano, Italy.
Abstract:
Renal cell cancer (RCC) is the third most diagnosed genitourinary malignancy in the world. Nearly a half of the diagnoses and 60% of related deaths occur in low-middle income countries (LMs), where prognosis is generally poor. We conducted a systematic research of ClinicalTrials.gov, searching RCC ongoing studies for adult patients. We included 205 trials in the final analysis. The enrolling centers were mainly distributed in high-income settings (88.9%). We estimated 94.6% of the trial population was enrolled in only five countries and none in LMs. Clinical drug development for RCC is driven by early phase studies, mainly assessing small molecule tyrosine kinase inhibitors and immunotherapy or the combination. Sixty percent of the trials were industry sponsored. Only a minority of the trials were in the early setting of care, adjuvant or neoadjuvant therapy. Disparities in drug development in LMs mirror a common underestimation of the value of research among the national priorities in cancer health planning, resulting in poor ethnic diversity and inclusiveness. This commonly results in incomplete knowledge of activity and safety of medicines across different ethnic groups, with consequences on priorities for cancer interventions and estimates of benefit in LMs patients. The use of RCC as a case study for inclusiveness suggests poor inclusion of non- Caucasian populations in the trials, especially trials testing new immunotherapy and targeted agents where RCC drug development is more pronounced, resulting in issues of generalizability in other ethnic groups when these compounds are approved with no ethnic restrictions or specifications.
Insights
Renal cell cancer (RCC) drug development is heavily concentrated in high-income countries, excluding low- and middle-income nations. This limits understanding of treatment effectiveness across diverse ethnic groups.
Area of Science:
- Oncology
- Clinical Trials Research
- Global Health Disparities
Background:
- Renal cell cancer (RCC) is a significant global health challenge, disproportionately affecting low- and middle-income countries (LMs) with poorer prognoses.
- Current drug development for RCC predominantly occurs in high-income nations, with limited representation from LMs.
Purpose of the Study:
- To systematically analyze ongoing clinical trials for adult patients with renal cell cancer.
- To identify geographical distribution, sponsorship, and therapeutic focus of RCC clinical trials.
- To assess the inclusivity and ethnic diversity within RCC clinical trials.
Main Methods:
- Systematic search of ClinicalTrials.gov for ongoing RCC studies in adult patients.
- Inclusion of 205 trials in the final analysis.
- Analysis of trial enrollment locations, country distribution, sponsorship, and therapeutic settings.
Main Results:
- The vast majority of enrolling centers (88.9%) and trial participants (94.6%) were located in only five high-income countries.
- No trials were conducted in low- and middle-income countries.
- Clinical drug development primarily focuses on early-phase studies of tyrosine kinase inhibitors and immunotherapy, with limited trials in adjuvant or neoadjuvant settings.
- Significant underrepresentation of non-Caucasian populations, particularly in trials for new immunotherapies and targeted agents.
Conclusions:
- Geographical and ethnic disparities in RCC clinical trials raise concerns about the generalizability of drug efficacy and safety data.
- The lack of LM representation and ethnic diversity hinders understanding of treatment benefits for diverse global populations.
- Addressing these disparities is crucial for equitable advancement of renal cell cancer treatment worldwide.
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