Sex and Gender in Randomized Controlled Trials of Adults Receiving Maintenance Dialysis: A Meta-epidemiologic Study

Sex or Gender Reporting in Ophthalmology Clinical Trials Among US Food and Drug Administration Approvals, 1995 to 2022

“…In parallel with health, funding, regulatory, and government agencies, scholarly journals should mandate comprehensive and standardized incorporation of sex and gender in all stages of research. 12,14,15,18,20,41 Author guidelines on this topic have been increasingly adopted by high-impact journals since 2016, 43 indicating an ongoing evolution in the accurate integration of sex and gender that may extend to medical subspecialties and FDA-associated research in the future. Trial registries, such as ClinicalTrials.gov, may implement quality control checkpoints to ensure appropriate use of terminology and integration of sex and gender in participant randomization, covariate adjustment, subgroup analysis, and other aspects of trial design.…”

“…41 For example, preferred names and pronouns should be solicited and data collection forms should include sex-and gender-nonbinary options for self-report. 18,20 Additionally, sex-and gender-sensitive language (eg, participant instead of man or woman when gender has not been ascertained) should be used in all forms of communication. 18,20 Research teams should include individuals from sex, gender, racial, and ethnic minority populations to promote the participation, trust, confidence, and care satisfaction of individuals from these populations.…”

“…Author guidelines on this topic have been increasingly adopted by high-impact journals since 2016, indicating an ongoing evolution in the accurate integration of sex and gender that may extend to medical subspecialties and FDA-associated research in the future. Trial registries, such as ClinicalTrials.gov, may implement quality control checkpoints to ensure appropriate use of terminology and integration of sex and gender in participant randomization, covariate adjustment, subgroup analysis, and other aspects of trial design . Postgraduate institutions should be consulted to integrate education about best sex and gender research practices into medical and graduate training .…”

“…Research teams should include individuals from sex, gender, racial, and ethnic minority populations to promote the participation, trust, confidence, and care satisfaction of individuals from these populations . Funding bodies may consider creating incentives for enrolling minority populations and achieving well-powered, prespecified subgroup analyses . Educational and health care institutions may also consider increasing SGM representation in leadership positions, such as reviewer panels and steering committees .…”

“…In the meantime, postmarket surveillance strategies may be implemented to assess for sex- and gender-based differences in drug efficacy and safety. These efforts will promote equitable participation of underrepresented populations, ensure methodological rigor and reproducibility, strengthen health interventions and policies, and create a more inclusive ophthalmology community for all …”