Inclusion of Women in Clinical Trials -- Policies for Population Subgroups

Abstract

In summary, neither adherence to quotas in the composition of a study\ncohort nor the irrational exclusion of a subgroup of people can be supported\nscientifically. Determining the number of women to be included in a trial\nshould reflect reasonable hypotheses about the relation of treatment efficacy\nto sex, not global rules about the composition of study cohorts.