It may be hard for some people to imagine, but up until very recently women were rarely included in clinical research trials. In 1985, the U.S. Public Health Task Force on Women's Health issued a report saying that the historical lack of focus on women's health issues deprived women of proper health care and health information. The following year, the National Institutes of Health (NIH) established a policy to include women in clinical research.

"Women in the United States were routinely prescribed drugs that had not been tested for safety or efficacy in women, and there was little understanding of the differences between men and women that might result in differences in safety or efficacy of any medical intervention," said Sherry A. Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research, an advocacy organization in Washington, D.C.

Despite the 1986 policy announcement by the NIH to include women in clinical research, little was done to enforce it. By and large, women continued to be excluded from medical research studies. Things didn't really begin to change until 1990, when the federal GAO (Government Accountability Office) issued a report evaluating and criticizing the implementation and effectiveness of the 1986 NIH policy.

"One of the first advocacy efforts of the Society for Women's Health Research led to the request by Congress for the GAO to conduct a study into NIH's policies and practices regarding the inclusion of women and minorities in clinical trials," Marts said.

After the GAO report was released, public attention to the issue of including women in medical research began to grow. The NIH reinforced its policy on the inclusion of women and created the Office of Research on Women's Health (ORWH) to organize women's health research activities in all of the NIH institutes and centers.

Today, the Office of Research on Women's Health serves as the center for women's health research at the NIH. ORWH leads NIH efforts in making sure the original policy for including women is followed. In addition, ORWH:

-- advises the NIH Director and staff on matters relating to research on women's health;

-- strengthens and enhances research related to diseases, disorders, and conditions that affect women;

-- ensures that research conducted and supported by NIH adequately addresses issues regarding women's health;

-- ensures that women are appropriately represented in biomedical and bio-behavioral research studies supported by NIH;

-- develops opportunities for and supports recruitment, retention, reentry, and advancement of women in biomedical careers; and

-- supports research on women's health issues. ORWH works in partnership with the NIH institutes and centers to ensure that women's health research is part of the scientific framework at NIH and throughout the scientific community.

"The work of ORWH has fostered important research on women's health and on sex differences in health at NIH and beyond," Marts said. "NIH-supported studies have expanded our knowledge about areas such as lung cancer, colon cancer, and cardiovascular diseas areas where scientists once thought women were not largely affected. We now know these are key areas of women's health and important sex differences impact prevention, diagnosis and treatment. Patients, both women and men, reap the rewards of this work as we learn more and develop better care that is responsive to the individual's unique characteristics."

Society for Women's Health Research (SWHR)
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Society for Women's Health Research