Sex as an important biological variable in biomedical research

Abstract

Experimental results obtained from research using only one sex are sometimes extrapolated to both sexes without thorough justification. However, this might cause enormous economic loss and unintended fatalities. Between years 1997 and 2000, the US Food and Drug Administration suspended ten prescription drugs producing severe adverse effects on the market. Eight of the ten drugs caused greater health risks in women. Serious male biases in basic, preclinical, and clinical research were the main reason for the problem. This mini-review will describe why and how funding organizations such as the European Commission, the Canadian Institutes of Health Research, and the US National Institutes of Health have tried to influence researchers to integrate sex/gender not only in clinical research, but also in basic and preclinical research. Editorial policies of prominent journals for sex-specific reporting will also be introduced, and some considerations in integrating sex as a biological variable will be pointed out. To produce precise and reproducible results applicable for both men and women, sex should be considered as an important biological variable from basic and preclinical research. [BMB Reports 2018; 51(4): 167-173].

Fig. 1

Schematic drawing shows male-biased preclinical and clinical research can leave detrimental side effects for women undetected till marketing.

Fig. 2

Number of published editorials regarding sex/gender. Editorials and comments mentioning ‘sex’ or ‘gender’ in title were searched in PubMed. Article numbers published during every five year are plotted except the last column which shows number of editorials published for two years, from 2016 to 2017.