National Research Council. "Inclusion of Women in Clinical Trials: Policies for Population Subgroups." Inclusion of Women in Clinical Trials: Policies for Population Subgroups. Washington, DC: The National Academies Press, 1993. 1. Print.
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Inclusion of Women in Clinical Trials: Policies for Population Subgroups
concern expressed by the AMA’s Council on Ethical and Judicial Affairs is that medical treatments of women are based on a male model despite the fact that women may react differently from men or that some diseases manifest themselves differently in women. The results of medical research are generalized to women without sufficient evidence of their applicability to women.
HAVE CLINICAL TRIALS EXCLUDED OR UNDERREPRESENTED WOMEN?
The literature is inconclusive as to whether women have been excluded or importantly underrepresented in clinical trials. Certainly, women of childbearing potential have been systematically excluded from most clinical research in early phases of drug development. The FDA recommends exclusion of women of childbearing potential from the early phases of study of a new drug except when the drug is intended to treat a life-threatening disease or a disease with severe morbidity. This category includes women using contraception and those not currently sexually active, but not those who have had a hysterectomy or tubal ligation.** Moreover, many of the largest clinical trials of cardiovascular disease have explicitly excluded women.13–17 On the other hand, in trials of the efficacy of a new drug, women have often been included roughly in proportion to the relevant prevalence of disease in men and women.18
BARRIERS TO FULL PARTICIPATION OF WOMEN IN CLINICAL TRIALS
Women face several types of barriers to full participation in clinical studies. Some barriers are ethical, some legal, some scientific, and some are the consequences of efforts to conserve scarce resources. These barriers result from: (1) the responsibility to protect the reproductive systems of women of childbearing potential and fetuses; (2) the fear of legal liability if a woman (or, subsequently, a child) suspects damage to a fetus or gamete due to a study; (3) the ease of recruitment, the compliance, and the condition of being at high risk for the endpoints being examined in a study cohort; (4) the availability of identifiable, convenient cohorts (e.g., veterans, army recruits); and (5) known variations in hormonal status affecting laboratory test results and inferences about treatments.19
**
On March 24, 1993, the Food and Drug Administration announced that it would end its ban on women’s participation in most drug safety tests and that it would require companies to do analyses by gender in virtually all new drug applications.
