Women In Clinical Drug Trials: United States Food And Drug Administration Update On Policies And Practices

It is now well established that subgroup populations deserve a careful assessment of their response differences in order to derive maximum benefit from medical products, and that the concept of 'one size fits all' is an antiquated approach to drug development. These concepts are integrated into the United States Food and Drug Administration's (FDA) drug development, regulatory review, and approval paradigm, and form the essence of personalized medicine. Factors affecting drug exposure and response, such as patient age, sex, race, and genetic makeup, have gained heightened attention due to emerging evidence of their outcome differences and scientific investigators now routinely examine these demographic features during clinical research. This chapter discusses the historical context of women's participation in clinical drug trials and how FDA regulatory policies and practices for addressing sex differences in treatment response have evolved over the years. An overview of this topic was discussed at the Gender Medicine Conference held in October 2010 in Stockholm, Sweden to commemorate the 200th anniversary of the Karolinska Institutet. Copyright (C) 2012 S. Karger AG, Basel