Inclusion of women in clinical trials - policies for population subgroups

Article Abstract:

Women are less likely to be included in clinical trials than men. Clinical trials are evaluations of different medical treatments or drugs that use human volunteers. Women and men may respond differently to different types of treatment. The exclusion or underrepresentation of women in clinical trials may affect the quality of care for female patients. A Congressional proposal outlines a policy to eliminate discrimination against women and minorities in medical research. With this policy, researchers receiving federal funding would have to determine whether the treatment being evaluated would affect women and minorities differently. Different reasons have been offered for the exclusion of women from clinical research trials. Women of childbearing age have traditionally been excluded because of potential harm to their fertility or a fetus. Large groups of men such as veterans are often more available for participation in research studies. Female hormones are considered more likely to affect research results. Medical researchers need to consider both the differences and the similarities between the sexes in clinical trials.

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Women in clinical trials of new drugs: a change in Food and Drug Administration policy

Article Abstract:

The Food and Drug Administration (FDA) has developed a set of guidelines that require researchers to include women in clinical research trials. Clinical research trials evaluate the effectiveness and safety of new medical procedures and drugs in human volunteers. Men and women may have a different response to the same drug. Different sex-related characteristics that can affect this response include body size, body fat content and distribution and sex hormones. The new FDA guidelines also require researchers to identify these types of sex-related differences for specific drugs. The FDA also changed its 1977 policy against the inclusion of women of childbearing age in the earliest stages of clinical trials. All women of childbearing age can now participate in the earliest stages of clinical trials under certain circumstances. Pregnant women with AIDS may also be included in the earliest stages of clinical trials.

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Approval of new drugs in the United States: comparison with the United Kingdom, Germany, and Japan

Article Abstract:

An analysis by the FDA reveals that Americans have access to the most important drugs and have been spared drugs that have little benefit. Of the 214 new drugs approved on the world market between 1990 and 1994, 29 have been approved in Great Britain but not the US, 34 have been approved in Germany but not the US and 82 have been approved in Japan but not the US. None of the 29 UK-approved drugs have significant benefit to US patients and only 1 of the 34 German-approved drugs and 3 of the 82 Japan-approved drugs fall into this category. FDA drug approval times have dropped from an average of 33 months in 1987 to 17 months in 1994.

Drugs, International aspects, Testing, Drug approval

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