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Shedding a light on sex disparity in clinical trials in CKD patients
Francesca Mallamaci1,2, Giovanni Tripepi2
1Nephrology, Dialysis, and Transplantation Unit, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" of Reggio Calabria, Italy.
Abstract:
Clinical studies do not include an adequate proportion of female participants, and research data on drug efficacy and safety are generally collected from studies including a majority of men and extrapolated to women. This article describes the imbalance of male and female distribution in clinical studies, including patients with chronic kidney disease. The lack of sex equity in clinical research is a real 'public health problem' because not reporting sex-specific results may result in the loss of information on how a drug works according to sex. Therefore, it is essential to plan more research in the field of sex disparities in clinical studies to identify why women are underrepresented and to promote initiatives to expand women's participation in clinical studies.
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