More accurate sex, gender reporting vital for equitable ophthalmic research
Click Here to Manage Email Alerts
Key takeaways:
- Of 85 clinical trials reviewed, only 19.5% correctly used sex and gender terminology.
- No trial reported how sex and gender were collected nor enrolled people from sex and gender identity minority populations.
Consideration of sex and gender in trial design, enrollment and data analysis is needed to improve the validity and equity of ophthalmology trials associated with FDA drug approvals, according to research in JAMA Ophthalmology.
“This cross-sectional analysis of clinical trials associated with FDA approval of ophthalmic drugs demonstrated marked conflation of sex and gender terminology, underreporting of sex and gender assessment methods, and inattention to sex- and gender-based analysis,” Jim Shenchu Xie, BHSc, from the Michael G. DeGroote School of Medicine at McMaster University in Ontario, Canada, and colleagues wrote. “Increased consideration of sex and gender in trial design, enrollment and dissemination is needed to draw stronger conclusions about therapeutic efficacy and safety.”
In an analysis of 85 trials corresponding to 34 ophthalmic drugs that received FDA approval from 1995 to 2022, researchers reviewed trial protocols and supplementary materials to assess the accuracy of applied sex and gender terminology, whether methods of assessing sex and gender were reported and whether sex- and gender-based analysis were conducted.
Xie and colleagues found that just 19.5% of the trials correctly used sex and gender terminology. In addition, while 96.5% of trials reported sex- and gender-disaggregated demographic data, only 1.2% conducted sex- or gender-based analysis for data on dropout, 28.2% for primary outcomes, 2.4% for secondary outcomes and 9.4% for adverse events.
None of the trials reported how sex and gender were collected and none enrolled individuals from sex and gender identity minority populations, researchers reported.
Further, later publication year, lower number of study sties, larger sample size and higher journal influence metrics were associated with incorrect application of sex and gender terminology.
“Best practices for sex and gender analysis and reporting should be enforced by scholarly journals in collaboration with educational institutions, funding bodies, and regulatory agencies,” Xie and colleagues wrote. “International, coordinated efforts will help to promote equitable, rigorous research and a more inclusive ophthalmology community.”
Collapse
Read more about
Click Here to Manage Email Alerts