Participation of Women in Clinical Trials of Drug Therapies: A Context for the Controversies

Marianne N. Prout, MD, MPH, Susan S. Fish, PharmD, MPH

Disclosures
In This Article

Regulatory Changes to Include Women in Clinical Trials

The NIH, the FDA, and the Centers for Disease Control and Prevention (CDC) have developed policies, programs, and procedures to mandate and implement the inclusion of women and racial and ethnic minorities in research, as summarized in Table 3.[45,46,47,48,49,50,51] The NIH initially instituted a policy that urged inclusion of women in clinical research but now mandates that phase 3 clinical trials include adequate numbers of women and minorities to permit analyses of difference of effect of interventions, regardless of cost. In addition, NIH has developed programs for outreach efforts and methods to recruit, retain, and track participation of women and minorities in clinical studies; these include training for NIH staff, IRB chairs, and review committees and provision of practical resources, such as their outreach notebook.[52,53,54]

The FDA issued a Gender Guideline that ended restrictions on premenopausal women's participation in early-phase drug trials, encouraging IRBs, investigators, and potential research participants to evaluate risks and benefits of inclusion of women of childbearing potential on a study-by-study basis.[50] In 1995, the FDA convened a Gender Workshop that issued the following recommendations: (1) that questions of potential sex-specific effects be integrated at all phases of development of drugs, and (2) that potential differential effects by sex be assessed by analysis of pharmacokinetics or pharmacodynamics, metabolic pathways, or intended uses. In addition, sex-specific analyses in postmarketing surveillance systems were recommended in spite of concerns that analyses might only be performed on main treatment effects.[12] Such sex-specific analyses will require larger sample sizes, and funding agencies must be prepared for the increased research costs of these requirements.

Pregnancy concerns for research participants must be tempered by respect for women and their ability to make decisions. Model statements have been developed and required by local IRBs, such as: "We do not know the effects of this study drug on a fetus. If you are a woman who has sex with men, you should not become pregnant while you are taking this study drug and for x period of time afterward. We will discuss with you various ways to prevent pregnancy. If you become pregnant, you should discuss all options with your study doctor and your primary care doctor."

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