Reports of pivotal oncology trials fail to differentiate sex and gender, according to research published in the Journal of the National Cancer Institute.
Researchers analyzed more than 100 studies that led to the approval of cancer drugs in the United States.
None of the study reports made a distinction between sex and gender. In fact, none reported any information on the gender of participants.
“Clinical trials that do not analyze and report data by sex and gender risk drawing incorrect conclusions,” the researchers wrote.
They explained that “sex” refers to biological attributes, while “gender” refers to the socially constructed roles and behaviors that influence self-identity and self-expression. The terms “male”, “female” and “intersex” describe a person’s sex. Terms such as “man/woman,” “non-binary,” and “gender queer” describe gender.
For this study, the researchers assessed whether proper sex and gender terminology were used in oncology trials leading to regulatory drug approvals between 2012 and 2019.
The analysis included 128 studies associated with 127 approvals. Of the 128 studies, 113 were randomized controlled trials. Twenty percent of the studies (n=26) were designed to evaluate sex-specific cancers, including prostate, breast, endometrial, ovarian, and cervical cancer.
The researchers found that none of the study reports described how sex and gender information was collected or assessed. Furthermore, none made any distinction between sex and gender terminology, and none included information on the gender of participants.
At least 1 inconsistency in the use of sex and gender terms was identified in 76% of trials (97/128). Eighty percent (82/102) of the studies conducted in non-sex-specific cancers had at least 1 inconsistency, as did 58% (15/26) of the sex-specific cancer trials.
Of the trials for non-sex-specific cancers, 89% presented disaggregated data by sex or gender. However, none of the trials presented disaggregated adverse events by sex or gender.
“More rigor in designing clinical trials to include sex- and gender-based analyses and more care in using sex and gender terms in the cancer literature is needed,” the researchers wrote.
They noted that gender and sex may be important in determining the safety of a cancer therapy. Therefore, precise use and reporting of sex and gender terminology is not just an issue of inclusivity, but of good science.
Hall M, Krishnanandan VA, Cheung MC et al. An evaluation of sex- and gender-based analyses in oncology clinical trials. J Natl Cancer Inst. Published online April 27, 2022. doi:10.1093/jnci/djac092