Sarah K. Keitt


While women generally live longer than men, they often do not live healthier. Historically, women have suffered from a lack of medical information specific to their needs and problems. This information gap is the result of policies and practices that excluded women from participating as research subjects in most clinical trials until the late 1980s. Women were initially excluded from participating in clinical trials due to neglect and, after the Thalidomide tragedy of the 1960s, misguided efforts at protection. It was not until the mid-1980s that the medical research community began to recognize that the information gap created by these policies had a detrimental effect on women's health and began to take action to fill this gap.

This Article explores issues surrounding women's participation in clinical trials. Part I outlines the cultural and regulatory norms that for many years resulted in the exclusion of women from clinical trials. It includes a discussion of protectionist regulations, landmark legislation, and the backlash against the women's health movement. Part II provides recommendations for improving the research process to allow for more equitable and scientifically sound research on the health issues that affect women. These recommendations include closer attention to the needs of female research participants, as well as novel methods of study design and data analysis.