title: Need for gender-specific pre-analytical testing: the dark side of the moon in laboratory testing.
abstract: Many international organisations encourage studies in a sex-gender perspective. However, research with a gender perspective presents a high degree of complexity, and the inclusion of sex-gender variable in experiments presents many methodological questions, the majority of which are still neglected. Overcoming these issues is fundamental to avoid erroneous results. Here, pre-analytical aspects of the research, such as study design, choice of utilised specimens, sample collection and processing, animal models of diseases, and the observer's role, are discussed. Artefacts in this stage of research could affect the predictive value of all analyses. Furthermore, the standardisation of research subjects according to their lifestyles and, if female, to their life phase and menses or oestrous cycle, is urgent to harmonise research worldwide. A sex-gender-specific attention to pre-analytical aspects could produce a decrease in the time for translation from the bench to bedside. Furthermore, sex-gender-specific pre-clinical pharmacological testing will enable adequate assessment of pharmacokinetic and pharmacodynamic actions of drugs and will enable, where appropriate, an adequate gender-specific clinical development plan. Therefore, sex-gender-specific pre-clinical research will increase the gender equity of care and will produce more evidence-based medicine.
authors.affiliation: Department of Biomedical Sciences, University of Sassari, National Laboratory of Gender Medicine of the National Institute of Biostructures and Biosystems, Osilo, Sassari, Italy; Vicepresident of Basilicata Region. Electronic address: franconi@uniss.it.
authors.forename: Flavia
authors.initials: F
authors.lastname: Franconi
authors.affiliation: Cardiovascular and Cell Sciences Research Institute, St George's University of London, United Kingdom.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rosano
authors.affiliation: Department of Biomedical Sciences, University of Sassari, National Laboratory of Gender Medicine of the National Institute of Biostructures and Biosystems, Osilo, Sassari, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Campesi
mesh_terms: D000818:Animals; D035843:Biomedical Research; D019411:Clinical Laboratory Techniques; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008297:Male; D012107:Research Design; D012737:Sex Factors
keywords: Pre-analytical conditions; Research complexity; Sex–gender