Study Estimates Gender Bias in U.S. Clinical Trials, Finds Men–Not Women–Underrepresented in Most Research

Posted: December 24, 2013 in Medical Research
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New Study Compares Male-Only and Female-Only Trials to Mortality Rates

Contrary to longstanding public perception, women do not appear to be under represented or understudied in scientific clinical research trials in the United States, according to a new study by researchers at the Johns Hopkins University Bloomberg School of Public Health. The findings were most pronounced among cancer related clinical trials. The researchers concluded that women are represented in twice as many cancer trials compared to men, even though men die more frequently from the disease and often die at an earlier age. The study is the first to quantify gender bias in clinical research. Researchers measured the levels of bias by comparing male-only and female-only trials with death rates for each sex from heart disease, malignant cancer, and other causes. The findings appear in the April 30, 2001 edition of Statistics in Medicine.

“The findings are important because the perception that females are under represented and their diseases are understudied erodes the public trust, which is essential to continued clinical research,” says Curtis L. Meinert, PhD, professor of epidemiology and director of the Center for Clinical Trials at the Johns Hopkins University Bloomberg School of Public Health.

For years, policy makers and the general public have assumed that medical research favored men over women. The perception was so compelling that Congress enacted legislation in 1993 explicitly requiring the inclusion of women in clinical trials.

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