Over the past two decades, there have been significant efforts to improve the participation of women in clinical trial research. However, a new report shows that even while women may be represented in clinical trials, the data obtained from both male and female study participants are rarely analyzed by sex [1].

The study conducted in collaboration by the University of Illinois at Chicago Center for Research on Women and Gender and the University of Wisconsin-Madison Center for Women's Health Research, reviewed the results of 107 NIH-funded, randomized controlled trials published in 2015 which included both male and female participants. They found that 72% of clinical trials failed to analyze their data by sex, report any sex-specific outcomes of their work, nor provide an explanation as to why sex was excluded in their analyses. In addition, this represents an increase in the lack of sex-specific reporting from 67% in 2004 and 64% in 2009.

Failing to analyze clinical research data by sex has significant implications for both men and women. When clinical research data is analyzed by sex, it can identify key differences which impact health and disease, giving us the ability to design and develop individualized therapies or treatments. To encourage sex-based analyses, the study authors recommend that researchers have open discussions regarding the influences of sex and gender, call upon journals to improve publishing guidelines for sex-specific reporting, and a revision of NIH-grant scoring policies based on study design and analyses.

To learn more about sex-inclusive research visit sexinclusion.northwestern.edu or consider registering for the 2nd Annual Symposium on Sex Inclusion in Biomedical Research!

1. Gellar et al. Acad Med. 2017 Oct 19. doi: 10.1097/ACM.0000000000002027. [Epub ahead of print].


Antibiotic trial data analyzed by sex

This issue is so important, even in simple infections! In a pivotal trial conducted almost 20 years ago, ~4% of patients presented with rash. This number is consistent with other antibiotics, and the clinical team discounted its importance. However, when the FDA asked for more specific data, it was found that ~40% of women under 40 experienced this rash. Not surprisingly, the product labeling was drastically effected. It seems that sex-specific analyses are only conducted for trials that are specific to women (e.g., endometriosis, UF, menopause). The example above indicates that this is simply not true.