Background
While there are no biological determinants of race, differences in disease course and response to treatment highlight the importance of racial information. Disadvantaged groups diagnosed with brain tumors experience higher morbidity and mortality, yet their inclusion in clinical trials remains limited. This is concerning given there are reports of differing efficacy across minority groups. Lack of racial reporting contributes to gaps in medical knowledge that further disproportionately affect minoritized groups. In this study, we perform a meta-analysis of astrocytoma clinical trials, with the primary objective of assessing the inclusion of race data in clinical trials.
Methods
This meta-analysis consisted of publicly available astrocytoma clinical trials of pharmacologic agents using ClinicalTrials.gov and included demographic data on race and sex categories. Two independent reviewers extracted study level data for a random effects analysis. Microsoft Excel was used for data collection and analysis. The primary outcome is the prevalence of studies that did not incorporate race/ethnicity data. The secondary outcomes are the prevalence of each demographic subgroup (White, Black, Combined Other) among all oncology clinical trials that reported this demographic information.
Results
A total of 1857 studies were identified through a search of randomized clinical trials using ClinicalTrials.gov with search term Astrocytoma including years 1996 to 2022. After including only completed interventional studies with results, 219 total trials were analyzed. Out of 219 studies, 131 (58.82%) did not report race. The remaining 88 clinical trials that reported demographic data were analyzed. 40.32% of trial participants were female and 59.35% were male. 81.8% of trial participants were white, 4.98% were black, 3.71% were Asian, and 9.51% were “combined” category (Not reported, Unknown, Other, American Indian, Native Hawaiian, multiple races).
Conclusions
Despite the importance of reporting demographic data, more than half of astrocytoma clinical trials did not report racial data. In addition, of those trials that did report race data, we found that White participants were disproportionately represented (81.8%) while Asians, Black, American Indian, Native Hawaiian and others were underrepresented in the clinical trials. These results highlight disparities in clinical trial participation, and questions how applicable targeted therapies might be if they are not used on diverse populations.