Discussion on Different Phases of Clinical Research

Sex and Gender in Biomedical Research : Discussion on Different Phases of Clinical Research

Inclusion Regulations and Policies

The shift in policy from protectionism with exclusions to broad inclusion of women in research studies with appropriate human subject protections has done more than ever to help both women and men through the development of effective interventions. The inclusion policy has begun, and will continue, to lead to more specific knowledge about sex differences as it:

• Encourages sex-specific research in all phases of clinical study and the design of clinical research to detect sex differences.
• Supports research that provides adequate assurance that potential differential effects by sex will be assessed by analysis of pharmacokinetics or pharmacodynamics, metabolic pathways, or intended uses.