NCPA - National Center for Policy Analysis

Report Finds Women are Adequately Represented in Drug Trials

August 14, 2001

Because of potential sex differences in the safety and efficacy of new drugs, it is important to include women and men in all stages of drug development and to analyze the resulting data for sex differences. Concerns have been expressed for years that women are underrepresented in drug trials. In 1992 the General Accounting Office (GAO) reported that the Food and Drug Administration (FDA) was not adequately ensuring the representation of women or the study of sex differences in clinical drug trials conducted by the pharmaceutical industry. But beginning in 1993, the FDA undertook a series of regulatory actions to ensure that women are represented in drug trials.

To determine if the drug industry and FDA had improved the representation of women, GAO investigators reviewed 36 FDA new drug applications (NDA) submitted from August 10, 1998, through December 31, 2000, and randomly sampled 100 annual reports for investigational new drugs.

While the GAO found about one-third of the applications and reports did not meet FDA requirements for data presentation, they nevertheless showed:

  • Women were the majority of clinical drug trial participants for over half of the new drug applications reviewed.
  • Overall, women were 52 percent of the study participants in all of the new drug applications in the sample.
  • However, there was considerable variation -- women were 22 percent of the participants in the initial, small-scale safety trials used to set the dosing levels for larger-scale trials but were more than one-half of the participants in the subsequent larger trials.

Thus, the GAO concludes that "All of the new drug applications included enough women to demonstrate statistically that the drug was effective in women."

Source: "Women's Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement," Report to Congressional Requestors, GAO-01-754, July 6, 2001, General Accounting Office.

For report text


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