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. 2024 Jul 24;14(8):926.
doi: 10.3390/life14080926.

A Cross-Sectional Analysis of Interventional Clinical Trials in High-Grade Glioma Therapy

Angelo Angione  1   2 , Jonathan Patterson  1 , Ebrar Akca  1 , Jessica Xu  1 , Emily Xu  1 , Vanessa Raab  3 , Omar Elghawy  4 , Adam A Barsouk  4 , Jonathan H Sussman  1   5
Affiliations

A Cross-Sectional Analysis of Interventional Clinical Trials in High-Grade Glioma Therapy

Angelo Angione et al. Life (Basel). .

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.

Keywords: clinical trial demographics; glioblastoma; health disparities; high-grade glioma; rural healthcare access; socioeconomic status.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Overview of search strategy for identification of relevant clinical trials.
Figure 2
Figure 2
Race and ethnicity in HGG clinical trials. (A) Percentage of trials reporting race and ethnicity published between 2011 and 2024. Significance in longitudinal trends was calculated using Spearman’s correlation coefficient. (B) Clinical trial participants by race and ethnicity category. AI/AN, American Indian/Alaska Native.
Figure 3
Figure 3
Trial demographic reporting by trial type. (A) Percent of reporting race by trial type (mixed, private, public) including any race reporting (left) and race reporting by OMB standards (right). (B) Percent of trials reporting ethnicity by trial type. (C,D) Percent of trials reporting race or ethnicity (D) by trial phase (Early Phase 1, Phase 1, Phase 2, Phase 3). (E,F) Percent of trials reporting race (E) or (F) ethnicity by funder type (industry, network, NIH, other). Data are shown for the years 2011–2024.
Figure 4
Figure 4
Geographic characteristics of high-grade glioma clinical trials across the United States. (A) Incidence rate of high-grade glioma by state, shown as rate per 100,000 individuals. (B) Number of independent clinical trials conducted in each US state. (C) Number of clinical trial sites in each state. (D) Median annual household income (US dollars) in each state.
See this image and copyright information in PMC

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