Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies
1
Laboratory of Sex-gender Medicine, National Institute of Biostructures and Biosystems, 07100 Sassari, Italy
2
Dipartimento di Scienze Biomediche, Università degli Studi di Sassari, 07100 Sassari, Italy
3
Value and Access Head, Novartis Italia, 21040 Origgio, Italy
4
Nouscom SRL, 00128 Roma, Italy
*
Author to whom correspondence should be addressed.
Cells 2019, 8(5), 476; https://doi.org/10.3390/cells8050476
Received: 6 March 2019
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Revised: 7 May 2019
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Accepted: 9 May 2019
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Published: 17 May 2019
(This article belongs to the Special Issue Sex Differences in Signaling Pathways)
There is a clear sex–gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex–gender into clinical trials.
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Keywords:
sex–gender; biomarkers; biorhythms; psycho-social and environmental factors; clinical trials
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
MDPI and ACS Style
Franconi, F.; Campesi, I.; Colombo, D.; Antonini, P. Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies. Cells 2019, 8, 476. https://doi.org/10.3390/cells8050476
AMA Style
Franconi F, Campesi I, Colombo D, Antonini P. Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies. Cells. 2019; 8(5):476. https://doi.org/10.3390/cells8050476
Chicago/Turabian StyleFranconi, Flavia, Ilaria Campesi, Delia Colombo, and Paola Antonini. 2019. "Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies" Cells 8, no. 5: 476. https://doi.org/10.3390/cells8050476
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