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A Cross-Sectional Analysis of Interventional Clinical Trials in High-Grade Glioma Therapy
Angelo Angione1,2, Jonathan Patterson1, Ebrar Akca1
1Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, PA 19104, USA.
Abstract:
High-grade glioma is the most frequent and lethal primary tumor of the central nervous system. Despite advances in surgical, pharmacological, and cell-directed therapies, there have been no updates to the standard of care in over a decade. This cross-sectional study analyzes patient and trial data from 201 interventional trials completed between 2010 and 2023, encompassing 18,563 participants. Although we found that all trials reported participant age and sex, only 52% of trials reported participant demographics, resulting in 51% of total participant demographics being unreported. The majority of studies did not report ethnicity, with approximately 60% of participants unreported. Additionally, males were significantly underrepresented in trials, comprising 60% of participants despite representing 75% of glioblastoma patients. Improved demographic reporting has been observed since 2011; however, it is inconsistent. Furthermore, we cataloged the geographic diversity of trials across the United States and found significant coverage deserts in relatively rural, but highly affected, areas such as Montana and Maine. We found a wider distribution of trials in both urban and wealthier regions, which indicates extensive coverage gaps and decreased access to participation for patients of a lower socioeconomic status.
Insights
Clinical trials for high-grade glioma lack comprehensive demographic data and equitable geographic representation. This limits understanding of treatment efficacy across diverse patient populations and hinders access to novel therapies.
Area of Science:
- Neuro-oncology
- Clinical trial methodology
- Health equity
Background:
- High-grade glioma remains a leading cause of cancer-related death, with stagnant standards of care for over a decade.
- Despite therapeutic advancements, clinical trial participation and data reporting present significant challenges.
Purpose of the Study:
- To analyze demographic and geographic reporting in high-grade glioma interventional trials.
- To identify disparities in participant representation and trial accessibility.
Main Methods:
- Cross-sectional analysis of 201 interventional trials completed between 2010 and 2023, including 18,563 participants.
- Evaluation of reported demographic data (age, sex, ethnicity) and geographic distribution of trials across the United States.
Main Results:
- While age and sex were universally reported, only 52% of trials reported other demographics, leaving 51% unreported.
- Ethnicity data was largely missing (60% unreported), and males were underrepresented (60% of participants vs. 75% of glioblastoma patients).
- Significant geographic "coverage deserts" were identified in rural areas, with trials concentrated in urban, wealthier regions, suggesting socioeconomic barriers to participation.
Conclusions:
- High-grade glioma trials exhibit critical gaps in demographic and geographic reporting, impacting generalizability and equity.
- Inconsistent improvements in reporting and unequal trial site distribution necessitate targeted interventions to enhance patient access and data completeness.
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