Women in Clinical Trials of New Drugs -- A Change in Food and Drug Administration Policy

Abstract

The Food and Drug Administration (FDA) is taking two important steps\nto ensure that new drugs are properly evaluated in women. First, it is\nproviding formal guidance to drug developers to emphasize its expectations\nthat women will be appropriately represented in clinical studies and that new\ndrug applications will include analyses capable of identifying potential\ndifferences in drug actions or efficacy between the sexes. Second, the agency\nis altering a 16-year-old policy that has excluded most women with\n"childbearing potential" from the earliest phases of clinical trials. \nAttention to sex differences is part of a larger effort by the FDA to ensure\nthat the safety and efficacy of drugs are adequately studied in the full range\nof patients who will receive therapy and that information is obtained that\nwill allow physicians to individualize therapy. These actions are also being\ntaken in response to questions about whether this country's drug-development\nprocess produces adequate information about the effects of drugs in women, as\nwell as more general issues concerning women's health.