Strategies to optimize inclusion of women in multi-national clinical trials

The proportion of women represented in clinical trials in the United States has been increasing and, in many but not all therapeutic areas, equivalent to that of men. This is an important achievement since safety, efficacy, and effectiveness of medical products and interventions differ by population subgroup. Outside the US however, there are significant complexities to the inclusion of women. Considerations for the inclusion of women that would make participation less burdensome are suggested as are other approaches to rectify underrepresentation. Appropriate subgroup analysis will contribute to an understanding of biological differences as well as to health equity.