Gender representation in drug development studies for diabetes mellitus. A systematic review

Abstract

Background: During the last 20 years, the prevalence of diabetes mellitus (DM) has increased drastically, and so has the number of associated medicine and drug development studies. Despite knowing that men and women respond differently to DM medicines, biological gender differences still tend not to be prioritized during medicine development.

Objective: This study examined gender representation in medicine development studies for DM.

Method: We conducted a systematic review, and in February 2022, we searched EMBASE (Excerpta Medica Database), MEDLINE (Medical Literature Analysis and Retrieval System Online) and PubMed using a block search strategy. Randomized controlled studies (RCTs) including people diagnosed with DM (any type) aged 18-65 years were included. The Consolidated Standards of Reporting Trial 2010 checklist was applied to assess the studies' reported quality. The results are presented in a narrative synthesis.

Results: Nine studies met the inclusion criteria. On average, women represented 31.4% of study participants, and similarly, for each trial phase, women were less represented than men.

Conclusion: This review showed an unequal gender representation in drug development studies for DM, with women and men representing 31.4% and 68.6% of the study participants, respectively, in the included studies. However, gender differences in medical drug studies might be due to specific exclusion criteria, participants' behaviour toward attending in medicine development or the law in the country of origin.

Keywords: Diabetes mellitus; Gender differences; Medicine development; Narrative synthesis; RCT; Systematic review.