Volume 179, 20 January 2015, Pages 514–535
Review
Need for gender-specific pre-analytical testing: The dark side of the moon in laboratory testing
Highlights
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- Numerous methodological problems appear considering the sex–gender in experiments.
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- We discuss pre-analytical aspects of research.
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- Gender-specific pre-clinical research will produce more evidence-based medicine.
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.
Keywords
- Sex–gender;
- Research complexity;
- Pre-analytical conditions
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