Reporting Sex, Gender, or Both in Clinical Research?
In this JAMA Viewpoint, Dr. Janine Clayton explains the differences between sex and gender and how clinical research needs to account for these variables since hormones, genes, and gender-related environmental exposures all affect human health. (November 2016)
Sex Differences in Animal Models: Focus on Addiction This review article, co-authored by National Institute on Alcohol Abuse and Alcoholism Director George Koob, discusses ways to think about and study sex differences in preclinical animal models. The review emphasizes not only significant differences in the phenotypes of females and males in the domain of addiction but also the limited data available regarding researchers' understanding of those differences. (April 2016)
Basic science: Bedrock of progress Dr. Clayton, along with Dr. Collins and other NIH senior leaders, co-authored a letter in Science confirming NIH's continued support of basic research. The letter explains that the pursuit of fundamental knowledge is essential for the achievement of medical advances and, in turn, a healthier future. (March 2016)
How to study the impact of sex and gender in medical research: a review of resources.
This paper aims to assist basic researchers, clinical investigators, as well as epidemiologists, population, and social scientists by providing an annotated bibliography of currently available resource tools on how to consider sex and gender as independent variables in research design and methodology. These resources will assist investigators applying for funding from the National Institutes of Health since all grant applicants will be required (as of January 25, 2016) to address the role of sex as a biological variable in vertebrate animal and human studies. (October 2015)
Why Science Needs Female Mice The New York Times Editorial Board discusses NIH's new policy requiring NIH-funded scientists to consider the biological variable sex in preclinical research studies. (July 2015)
The Upsetting Reason Why We Don't Know Nearly Enough About How Meds Affect Women Dr. Janine Clayton was included among other experts in this in-depth Refinery29 article looking at issues of inclusion in health research and the need to consider the biological variable sex from the very start: in preclinical research. "We want to be sure that considering sex as a biological variable is not an afterthought," she said. (July 2015)
Sex Differences And Pain (Subscription required) Over the past 15 years, neuroscientists have pieced together one particular biological circuit that they think is involved in some chronic pain conditions. But work on this mechanism left out some important subjects: females. In Chemical & Engineering News, Dr. Janine Clayton comments on this new study that highlights the risk of ignoring sex in biomedical research. "The study is another in a growing number of examples showing how sex influences biology from cells to selves," said Dr. Clayton. "Studies like this show that it's vital to study both sexes." (July 2015)
Focus on Sex The Scientist highlights new research findings and guidelines that brought increased attention to the biological differences between males and females in 2014. (December 2014)
Dr. Janine Clayton was interviewed for Discover magazine's Top 100 Stories of 2014. In Top-to-Bottom Sex Bias in Labs Skews Results , she comments on the blind spot that has resulted from studying only one sex, and the need to study both sexes to strengthen science. (December 2014)
On September 23, 2014, ORWH and the NIH Common Fund announced $10.1 million in supplemental funding to bolster the research of 82 grantees to explore the effects of sex in preclinical and clinical studies. (September 2014)
In this issue of AAOS Now, Dr. Joan McGowan, director of the Division of Musculoskeletal Diseases at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), explores the rationale behind the NIH changes to consider both sexes in preclinical research. Also included is her podcast interview about musculoskeletal sex differences. (September 2014)
In a Nature Comment "Policy: NIH to balance sex in cell and animal studies" published on May 14, 2014, Dr. Francis Collins and Dr. Janine Clayton outlined NIH steps to address sex differences in preclinical research. This news was covered widely in the media. (May 2014)
Female mice liberated for inclusion in neuroscience and biomedical research This meta-analysis of 293 articles on behavioral, morphological, physiological, and molecular traits demonstrates that variability is not significantly greater in females than males for a range of endpoints, and it shows that variability is substantially greater in males than females for many traits. (March 2014)