Gender and ethnic diversity in randomised clinical trials in age-related macular degeneration and diabetic macular oedema.

Abstract

In recent years, there has been increasing recognition of the importance of diversity in pivotal randomised clinical trials (RCTs). This is vital to ensure the validity and applicability of the results in the clinical setting. In this review, we aim to assess the inclusion of females and minoritized groups in recent RCTs in age-related macular degeneration (AMD) and diabetic macular oedema (DMO) and explore any potential barriers to their enrolment. Overall, a female predominance was observed among the AMD RCTs while less than half of the study population in DMO trials were females. White participants made up the majority of the study population in both AMD and DMO trials. Gender distribution within minoritized groups has only been reported in a few trials but appears lower than in the white population. This disparity may be attributable to the difference in the prevalence of diseases between these subgroups, as well as social and/ or cultural reasons. Nonetheless, there has been an overall increase in representation of minoritized groups over the past two decades. These observations provide important perspectives to consider when applying clinical trial learnings to clinical settings.