Suggested Principles for Sex and Gender Data in Ophthalmology Clinical Trials

Abstract

Xie et al 1 assessed how sex or gender terminology were applied in ophthalmology clinical trials associated with US Food and Drug Administration (FDA) drug approvals. Sex is a biological construct that is based on physiology, anatomy, hormones, and genetics. 2,3 Gender is a multidimensional construct encompassing both gender expression and identity. 2,3 Xie and colleagues reported that sex and gender terms were applied incorrectly (using sex and gender interchangeably, sex-related terms in reference to gender, and gender-related terms in reference to sex) 80.5% of the time in 85 clinical trials. They also found that while 96.5% of clinical trials reported sex and gender disaggregated demographic data, only 23.5% of clinical trials conducted sex-or gender-specific analysis for the main outcome, 2.4% of clinical trials conducted sex-or genderspecific analysis for the secondary outcome, and 3.5% conducted sex-or gender-specific analysis for adverse events. Based on these findings, the authors 1 call for more rigorous integration of sex and gender in clinical trials to improve their validity and equity. The authors note that even if a clinical trial is not powered to assess differences by sex or gender, which may not always be possible, characterizing outcomes by sex and/or gender in a consistent manner will enable future meta-analyses that may be sufficiently powered to assess gender-or sex-based outcomes. Current best practices for sex and gender data reporting are outlined in the Sex and Gender Equity in Research (SAGER) guidelines. 1 While the SAGER guidelines address issues of both sex and gender in research studies, current and future ophthalmology clinical trials also should implement the FAIR (Findability, Accessibility, Interoperability, and Reusability) principles to help the scientific community access and aggregate sex-and genderbased data across clinical trials. 4 The first FAIR principle of findability highlights that datasets should be registered/indexed, identified, and described in both an unambiguous and clear method. 4 Thus, trials need to ensure that sex and gender information is clearly documented. Clear documentation is augmented when researchers use standardized inclusive sex and gender language to enhance the searchability and to minimize barriers to locate pertinent sex and gender data within the dataset. The FAIR accessibility principle highlights that data should be accessible in many formats and be stored in a secured and trusted repository. 4 The FAIR interoperability principle highlights the