Woodruff: Clinical Research Should Be More Gender-Specific


By Deborah Borfitz

June 16, 2008 | In virtually every medical discipline, there are unanswered questions pertaining to women’s health and well-being. Closing the gender gap in medical research may require more than simply including women in research studies, says Teresa Woodruff, executive director of the Institute for Women’s Health Research, recently launched by Northwestern University’s Feinberg School of Medicine.

“Women experience disease symptoms and respond to therapeutic treatments differently throughout their lifespan and across their monthly menstrual cycle,” says Woodruff. Hormone fluctuations and the possibility of pregnancy among pre-menopausal women have for decades been the rationale for excluding females from medical research. To this day, many researchers prefer using male animals over female animals in their laboratories simply because their hormone environment is less complicated.

Teresa Woodruff
Since the early 1990s, women have been represented as study subjects in higher numbers because the National Institutes of Health, as a condition of funding, now requires that researchers include women in all studies targeting diseases that impact both sexes. However, when male and female trial data gets blended, sex- and gender-specific findings are difficult to evaluate unless the trial was specifically designed to look for sexual dimorphisms, says Woodruff.

Traditionally, women’s health research has focused on issues such as pregnancy, menopause, and female-specific cancers, she adds. Only in the last five years, for example, has the medical community identified sex differences in cardiovascular disease, the leading killer of both men and women. Even far less is known about diagnosing and treating women with diseases of the brain, the musculoskeletal organs, and the immune system. Most reports on adverse drug reactions occur in women because females were not included in many of the early pharmaceutical studies.

Woodruff believes that women want to be a part of the answer. The Institute’s latest project, the Illinois Women’s Health Registry, opened three months ago and has already enrolled over 1,000 Illinois women who are willing to take part in Institutional Review Board-approved research conducted at Northwestern University. Registry participants will be matched to specific studies based on their self-reported health profiles. Woodruff says she hopes the registry “will help us identify priorities that will raise the health status of Illinois women, who now rank 33rd among the states.”

In addition to the registry, the Institute for Women’s Health Research is facilitating more women’s research by offering seed grants to young investigators and by developing an Animal Research Core that will encourage researchers to use female animal models in their studies.

“More physicians are beginning to recognize that sex and gender impact health, but they do not necessarily know the way it relates to age or genetics,” says Woodruff. “That level of sophistication doesn’t exist yet.” But “before we can get to personalized medicine, we need to understand basic sex differences.”

Woodruff predicts, “Ten years from now, the treatment of women and men will be different than it is today because of programs like the Institute for Women’s Health Research.”

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