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.