This paper covers the issues surrounding the use of women of childbearing potential in clinical trials. It provides an overview of the proposed Food and Drug Administration (FDA) Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, then provides the perspectives of the pharmaceutical industry and the FDA on the guideline. All parties participating in research are actively seeking out new ways to abide by the guideline and protect the rights of the women who participate in clinical trials. Continued communication between FDA and industry is imperative so that the goals of the guideline can be realized.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Government Printing Office; 1978.
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“Women of Childbearing Potential.” Guideline entitled “General Considerations for the Clinical Evaluation of Drugs” HEW Publication No. (FDA) 77–3040; 1977.
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Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. Thursday, July 22, 1993. Docket No. 93D-0236.
