Medical Student Stanford University School of Medicine Corona, California, United States
Disclosure(s):
Vaibhavi Shah: No financial relationships to disclose
Introduction: Poor participant recruitment is a common issue with clinical trials, causing misrepresentation of the population. In neurosurgery, few studies have explored racial, ethnic, and sex-based disparities that exist in neurosurgical patient populations. Studies that do highlight disparities in neurosurgical patient populations focus on those receiving treatment in hospital settings. However, when looking particularly at the context of clinical trial enrollment and outcomes, these analyses are limited. Understanding enrollment disparities and potential biases in data can help inform improving clinical practices.
Methods: Clinical trials in neurosurgery from 2008-present were identified from ClinicalTrials.gov. Trials were categorized into: spine, oncology, vascular, functional, and pediatric. Key variables were included: demographics (race/ethnicity, sex, age), trial purpose (treatment, diagnostic, preventative), intervention (drug/pharmaceutical, device, procedure, behavioral), and sponsor (industry, US government, academic). These variables were associated to race/ethnicity (American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, Black/African American, White, More than One, or Unknown/Not Reported and Hispanic/Not Hispanic) and sex (Male, Female, Other) using logistic regression. 2-sided statistical significance was used with 95% Confidence Intervals. Statistical analysis was conducted in R 4.1.1.
Results: Inclusion/exclusion criteria were applied resulting in n=767 trials. Preliminary results show the proportion of trials that reported race/ethnicity/sex data increased from 0.25 in 2008 to a peak of 0.8 in 2018. Most trials were academic-sponsored (n=206), followed by industry-sponsored (n=118), and federal-sponsored (n =45). The median proportion of female participants fell below US Census average. The median proportion of White participants fell above the US Census average, while the median proportion of Black, Asian, and Native American participants fell below US Census average.
Conclusion : To the best of our knowledge, this is the first study to review clinical trials across subspecialities in neurosurgery with an equity lens. Further analysis will be conducted that highlights key trends between sponsor type, purpose, intervention, and location to enrollment of minorities.
