Advancing the inclusion of underrepresented women in clinical research

Abstract

Women, and specifically women of color, are underrepresented in clinical trials, limiting biological understanding and contributing to health inequities and social injustice. Analyses of barriers to inclusion suggest practical interventions that together create a roadmap of specific and actionable steps to increase diverse representation in research and sustainable change.

Figure 1

Practical approaches, by study phase, for inclusion of women in clinical research For each study phase, a model checklist of actionable steps for the inclusion of women, and underrepresented subgroups of women, is presented. The study phases are divided into three parts: pre-study, on-study, and follow-up. In addition, considerations for post-approval trials (e.g., observational studies, comparative effectiveness research, platform or master trials, pragmatic or simple trials, trials utilizing real world data) are shown. The list is neither exhaustive nor prescriptive; considerations will vary by disease or condition, intended participant population, geographic, resources, and other factors.