Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement.

The appropriate representation of diverse populations in interventional trials remains problematic. A Delphi process was used to affirm the central role that ethics committees and institutions play in this process and to establish consensus upon 25 consolidated recommendations across four themes to promote diversity and inclusion in interventional clinical research.

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.

Advancing the inclusion of underrepresented women in clinical research.

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.