Sex as an important biological variable in biomedical research
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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.
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.
참고문헌 (35)
- "GAO-01-286R"[URL]
- Hughes RN, "Sex does matter: comments on the prevalence of male-only investigations of drug effects on rodent behaviour", Behav Pharmacol, 18, pp.583~589 (2007)[DOI]
- "Women's Health-FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing"[URL]
- Gochfeld M, "Sex Differences in Human and Animal Toxicology", Toxicol Pathol, 45, pp.172~189 (2017)[DOI]
- Institute of Medicine, "Exploring the Biological Contributions to Human Health: Does Sex Matter?" (2001)
- Regitz-Zagrosek V, "Sex and gender differences in pharmacology" (2012), Springer
- Yoon DY, "Sex bias exists in basic science and translational surgical research", Surgery, 156, pp.508~516 (2014)[DOI]
- Sechzer JA, "Sex and gender bias in animal research and in clinical studies of cancer, cardiovascular disease, and depression", Ann N Y Acad Sci, 736, pp.21~48 (1994)[DOI]
- Clayton JA, "Reporting Sex, Gender, or Both in Clinical Research?", JAMA, 316, pp.1863~1864 (2016)[DOI]
- Miller VM, "In pursuit of scientific excellence: sex matters", Am J Physiol Gastrointest Liver Physiol, 302, pp.G907~G908 (2012)[DOI]
- Beery AK, "Sex bias in neuroscience and biomedical research", Neurosci Biobehav Rev, 35, pp.565~572 (2011)[DOI]
- Zucker I, "Males still dominate animal studies", Nature, 465, pp.690~ (2010)[DOI]
- Kong BY, "Mind the Gap: Sex Bias in Basic Skin Research", J Invest Dermatol, 136, pp.12~14 (2016)[DOI]
- Zakiniaeiz Y, "Balance of the Sexes: Addressing Sex Differences in Preclinical Research", Yale J Biol Med, 89, pp.255~259 (2016)
- Klein SL, "Immune cells have sex and so should journal articles", Endocrinology, 153, pp.2544~2550 (2012)[DOI]
- Deasy BM, "A role for cell sex in stem cell-mediated skeletal muscle regeneration: female cells have higher muscle regeneration efficiency", J Cell Biol, 177, pp.73~86 (2007)[DOI]
- Penaloza C, "Sex of the cell dictates its response: differential gene expression and sensitivity to cell death inducing stress in male and female cells", FASEB J, 23, pp.1869~1879 (2009)[DOI]
- Taylor KE, "Reporting of sex as a variable in cardiovascular studies using cultured cells", Biol Sex Differ, 2, pp.11~ (2011)[DOI]
- Shah K, "Do you know the sex of your cells?", Am J Physiol Cell Physiol, 306, pp.3~18 (2014)[DOI]
- Park MN, "Insufficient sex description of cells supplied by commercial vendors", Am J Physiol Cell Physiol, 308, pp.578~580 (2015)[DOI]
- "AG Gender position paper 2018-2020"[URL]
- Duchesne A, "Funding agency mechanisms to increase sex and gender analysis", The Lancet, 389, pp.699~ (2017)
- Clayton JA, "Policy: NIH to balance sex in cell and animal studies", Nature, 509, pp.282~283 (2014)[DOI]
- Tannenbaum C, "Evaluating sex as a biological variable in preclinical research: the devil in the details", Biol Sex Differ, 7, pp.13~ (2016)[DOI]
- De Castro P, "Sex And Gender Equity in Research (SAGER): reporting guidelines as a framework of innovation for an equitable approach to gender medicine. Commentary", Ann Ist Super Sanita, 52, pp.154~157 (2016)
- Kilkenny C, "Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research", PLoS Biol, 8, pp.e1000412~ (2010)[DOI]
- Prager EM, "Addressing sex as a biological variable", J Neurosci Res, 95, pp.11~ (2017)[DOI]
- Fields RD, "NIH policy: mandate goes too far", Nature, 510, pp.340~ (2014)
- Sandberg K, "Sex and basic science. A Title IX position", Am J Physiol Regul Integr Comp Physiol, 307, pp.R361~R365 (2014)[DOI]
- McCullough LD, "NIH initiative to balance sex of animals in preclinical studies: generative questions to guide policy, implementation, and metrics", Biol Sex Differ, 5, pp.15~ (2014)[DOI]
- Sandberg K, "Recommendations concerning the new U.S. National Institutes of Health initiative to balance the sex of cells and animals in preclinical research", FASEB J, 29, pp.1646~1652 (2015)[DOI]
- Wald C, "Biomedical research. Of mice and women: the bias in animal models", Science, 327, pp.1571~1572 (2010)[DOI]
- Prendergast BJ, "Female mice liberated for inclusion in neuroscience and biomedical research", Neurosci Biobehav Rev, 40, pp.1~5 (2014)[DOI]
- Becker JB, "Strategies and methods for research on sex differences in brain and behavior", Endocrinology, 146, pp.1650~1673 (2005)[DOI]
- Khosla S, "Osteoporosis in men", Endocr Rev, 29, pp.441~464 (2008)[DOI]