This systematic review aims to examine all randomized controlled trials (RCT) leading to Food and Drug Administration (FDA) neurological drug approvals for: 1) sex and gender terminology accuracy; 2) sex- and gender-based analysis.

Sex and gender are distinct concepts each associated with independent health outcomes. Sex is a biological variable, whereas gender is a multidimensional psychosocial and cultural construct. Despite increasing recognition of sex and gender issues in neurology, they may be conflated or under-reported in the evaluation of neurological therapeutics. 

The drugs@FDA database was screened by two independent reviewers to identify all therapeutics approved by the FDA for a neurological indication between Jan 1, 1985 and Dec 31, 2023. All available RCTs cited in these approvals were included. Study characteristics, definitions and uses of sex and gender, sex- and gender-based analyses and mentions of sex and gender in discussion sections were extracted. Descriptive statistics and logistic regressions for associations between sex and gender variables and study characteristics were performed.

Our results identify shortcomings in reporting and analyzing sex and gender among neurological drug RCTs with no significant improvement over time.