Clinical research gender gap hurts women's health

Report calls for healthcare organizations to demand equality
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Clinical studies still overlook gender difference, which leaves women at a disadvantage and could endanger their health, according to a new report from the Mary Horrigan Connors Center for Women's Health & Gender Biology at Brigham and Women's Hospital in Boston. 

It's been more than 20 years since legislators mandated that clinical trials funded by the National Institutes of Health include women and minorities, but disease and drug studies often involve more men than women and don't break down the results by gender, according to the report. This information is crucial, especially when dealing with cardiovascular disease--the top cause of death among women in America--as well as depression, Alzheimer's disease and lung cancer, which all manifest in and affect women differently than men.

"Women are now routinely included in clinical trials, but we are far from achieving equity in biomedical research," report leader Paula Johnson, M.D., executive director of the Connors Center, told the Boston Globe.

For example, women's cardiovascular disease mortality rates decrease more slowly than men's, and the number of cardiovascular disease deaths for women with diabetes increased 23 percent. Yet only 35 percent of clinical trial cardiovascular research subjects are women, and only 31 percent of related studies report outcomes by sex, according to the report.

"If medical research is skewed to male physiology, women are at risk for incorrect diagnoses and inadequate treatment recommendations and missed opportunities for prevention," Jill Goldstein, Ph.D., director of research at the Connors Center, told the Boston Herald.

The report called for healthcare agencies and organizations to push for equality when it comes to gender research by:

  • Holding federal agencies accountable. Organizations should push the government to ensure clinical studies consider the subject's gender, equal participation between men and women and report sex stratified findings, according to the report. It also calls for the Food and Drug Administration to evaluate product safety data separately for men and women.

  • Promoting transparency regarding the absence of sex- and gender-based evidence in research by making researchers disclose the female subjects, including female animal subjects. The report also recommends an independent organization evaluate peer-reviewed scientific journals and rate the results on how often they present sex- and gender-based research.

  • Expanding sex-based research requirements. Researchers must start at the cellular and animal-research levels and include adequate female lab animal numbers, as well as human subjects, which medical and scientific journals should consider as criteria for publication. 

  • Adopting clinical care practices and training that include sex- and gender-based focus. Agencies and organizations must integrate sex and gender considerations into curriculum in medical schools and post-graduate education and training so the next generation of doctors will consider this in their research and practice, according to the report.

Such changes in research could cost more money, Johnson conceded, but she said the benefits to more research on female subjects can balance out those expenses.

"Can we afford not to do it? If we're not getting answers for women and for men, what are we losing in healthcare costs that we're spending today that could be saved in achieving wellness?" she said in a radio interview with WBUR, Boston's public radio station.

To learn more:
- check out the report
- here's the Herald article
- read the Globe article
- listen to Johnson's interview

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