Exclusion of Women From Clinical Research: Myth or Reality?

We found no routine exclusion of women; however, few publications analyzed results by sex. Some studies excluded women or men for apparently arbitrary reasons. Research performed with male-only participants differed in nature and size from that performed with female-only participants. These data indicate the need to track the sex of research participants. In addition, they provide the basis for assessing appropriate inclusion of men and women in research and for comparing any relationship between different international regulatory models and the rates of female participation in research.