WOMEN'S ISSUES: Guidelines for Clinical Trials


WOMEN'S ISSUES: Guidelines for Clinical Trials

Being Alive; November 1992
Nancy MacNeil

The FDA is considering a revision of their guidelines for the inclusion of women in clinical trials for all types of illnesses. Current guidelines suggest the exclusion of women of "child bearing potential" from all Phase I trials and from all trials until animal teratology and fetal toxicity studies have been completed. This has generally resulted in the exclusion of women from most clinical trials, unless they are post-menopausal or surgically sterilized.

The FDA defines "women of child-bearing potential" as "a premenopausal female capable of becoming pregnant." This includes women on oral, injectable or mechanical contraception: women who are single, women whose husbands have been vasectomized or whose husbands have received or are utilizing contraceptive devices. Most women with HIV/AIDS are women of "child bearing potential."

Although there is an exception for "some cases" when a life-threatening illness is concerned, drug companies are using the FDA guidelines to avoid including women at all. Yet, their drugs are sold to women after they are released and companies are not even required to say that they haven't been tested in "women" as a generic group. They only have to specify that the drugs have not been studied for "pregnant women."

The National ACT UP Network Women's Issues Committee is putting together "Ethical Guidelines for the Inclusion of Women in Clinical Trials." These guidelines are based on the premise that all people, men and women, must get all the information about what is known and unknown so that they can make informed decisions before entering a trial. The guidelines would eliminate the differences between the way men and women are treated under current guidelines. They would require companies to provide the most information possible without increasing the time for drugs to be released so much that they become useless for someone with a life-threatening illness.

Women would be treated the same way as men, that is, as people with the ability to make informed decisions about their own bodies and their lives. They cannot be treated paternalistically nor forced to put their lives at risk (for example, requiring HIV+ women to use IUDs, pills or other contraceptive devices which are problematic) to protect some drug company from "potential" liability for a "potential" fetus. These guidelines will also call for labelling that refers to women and for a large enough sample size of women in trials so that gender specific differences and effects can be investigated.

For a copy of the guidelines, call the Being Alive office.
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This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1992. AEGIS.