New Haven, Conn. — Women remain underserved by current health research practices, more than 20 years after a U.S. law called for their inclusion in clinical studies, according to a recently published paper by Women’s Health Research at Yale Director Carolyn M. Mazure.
“Although men and women differ in the prevalence, symptoms, and response to treatments for many health problems, we have a long way to go to fully include the influence of sex and gender on health in all biomedical research, from study designs and subject enrollment to analysis of results,” Mazure said.
In a paper for the online journal BioMed Central titled “Twenty Years and Still Counting: Including Women as Participants and Studying Sex and Gender in Biomedical Research,” Mazure chronicled the history of U.S. public policy toward the inclusion of women in health research, from the push to pass a law in 1993 finally requiring that women be included as participants in federally funded clinical studies to today’s incomplete progress.
Mazure describes in detail how despite continuous revisions of guidelines and recommendations, the U.S. Food and Drug Administration still does not require that new drug applications include women or that applicants analyze findings to consider sex or gender differences.
In addition, Mazure highlights how women remain underrepresented in clinical trials addressing cardiovascular disease and cancer, the first and second leading killers of both men and women in the United States. Even today, when women are included as subjects in clinical research, the effect of gender is not widely analyzed and reported. And most laboratory studies continue to use only male subjects.
“Everyone must take responsibility for ensuring these practices change, including members of the health care community, elected officials, and consumers,” Mazure said, offering detailed steps to improve policies and practices. “If we don’t demand that research and care account for the effects of sex and gender, we will all suffer from a lack of knowledge and potentially misguided medical decisions.”
The paper was co-written by Daniel Jones, former Press Officer and Science Writer for Women’s Health Research at Yale.
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