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Some research articles refer to this latter variable as sex, others refer to it as gender. As one of the first pieces of data reported, the importance of including sex appears undisputed. But what does the sex-gender category really entail, and how should it be reported? With emerging evidence that both sex and gender have an effect, for instance, on how an individual selects, responds to, metabolizes, and adheres to a particular drug regimen, 1 there is an ethical and scientific imperative to report to whom research results apply. This Viewpoint explains the contexts in which sex and gender are relevant and provides suggestions for improving reporting of this characteristic. Two common questions asked by clinical researchers are 1 Should the sex or gender of the study participants be reported?
According to the Institute of Medicine, every cell in our bodies has a sex , which means men and women are different at a cellular level. That also means that diseases, treatments, and chemicals might affect the sexes differently. For several reasons , female subjects have historically been excluded from toxicology or biomedical research, says Tamarra James-Todd, an epidemiologist at Harvard Medical School.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. The Find Studies section of this site describes the options for finding studies on ClinicalTrials. Conduct a search for studies using the form on the home page.