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BMJ 2001;323:360 ( 18 August )

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Drug trials still fail to include sufficient numbers of women

Deborah Josefson San Francisco

Efforts to limit sex bias in clinical drug trials have improved but are still inadequate, says a follow up report on the drug approval practices of the United States’ Food and Drug Administration (FDA), issued by the General Accounting Office.

The General Accounting Office is the investigative arm of the US Congress. In 1992 it found that not enough women were included in pre-approval clinical trials of drugs and charged the FDA with the task of improving women’s representation.

Equal representation of women is important because some drugs are metabolised and distributed differently in men and women. Drugs may reach higher concentrations in women because they generally have lower body weight and proportionally higher body fat content than men.

In formulating their latest report, investigators analysed 36 new drug applications that were reviewed and approved between 10 August 1998 and 31 December 2000 by the FDA for use in men and women.

Overall they found improvement in the representation of women, who currently constitute 52% of participants in studies of new drugs. But only 22% of the participants in the initial, small scale safety and toxicity trials used to set dosages in larger trials were women.

Despite improved numbers, however, analyses of sex differences in drug trials continue to be insufficient to make firm conclusions about differences in efficacy and side effects in men and women. The General Audit Office found that in 33% of pre-approval studies data on safety and efficacy were not segregated by sex. Furthermore, 39% of new applications did not include demographic data on age, sex, and race.

The office’s report also found that the FDA lacked a management system to record and track the inclusion of women in clinical drug trials and to monitor compliance with inclusion regulations. These findings were echoed in another recent report, which found that women and elderly people continue to be under-represented in studies on cardiovascular drugs and devices (JAMA 2001;286:708-13). Researchers at Duke University found that among people who had had heart attacks 33% were elderly and 43% were women, yet only 11% and 25%, respectively, of participants in cardiovascular trials were from these groups.

The report, Women’s Health: Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement (report GAO-01-754), is accessible at the General Audit Office’s website, www.gao.gov

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