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

Abstract

Although the inclusion of women and minorities in medical research is necessary for valid inferences about health and disease in these groups, both women and members of minority groups have been excluded from or underrepresented in many clinical trials. Congress has therefore proposed that the National Institutes of Health (NIH) ensure that all federally funded clinical research include a valid analysis to determine whether the intervention under study affects women or members of minority groups differently from other subgroups. In particular, Section 429B of the NIH Revitalization Act¹ provides that the director of the NIH shall ensure that women and members of minority groups are included in each research project. This requirement does not apply if their inclusion is inappropriate with respect to their health, the purpose of the research, or other circumstances that the director of the NIH may designate.