Areas to Focus On
Given that sex bias in clinical trials still exists, Dr. Farzal said researchers need to ensure that they strive for equal representation of both sexes in all trials. “We also need to report the sex of the subjects in all studies and analyze data by sex so that any sex-based differences are evident,” she added.
Explore This IssueJune 2019
For basic science studies, Dr. Farzal recommends making sure that new treatments or tests are performed in both male and female animals or cells prior to going live in a human testing trial phase.
Additionally, otolaryngology journals need to follow other periodicals, such as the Journal of the American Medical Association network journals, in setting requirements for sex reporting and statistical analysis by sex, Dr. Farzal added.
In his work, Dr. Senior saw that the best rates of sex-based analysis were found in database studies. Randomized controlled trials (RCT), however, were found to perform sex-based analysis in only 40% of cases. “Given the fact that much of our evidence-based medicine dogma and treatment algorithms are derived from RCTs, this problem area seems particularly important to tackle,” he said. “Researchers need to take care to perform sex-based matching when appropriate and to perform sex-based analysis of their results.”
By making the otolaryngology research community aware of sex bias in clinical research, Dr. Senior hopes that researchers will address these issues. Furthermore, journal editors can help by mandating that only studies following current recommendations on reporting and data analysis by sex be published. Single-sex studies should provide a
rationale for exclusion.
Karen Appold is a freelance medical writer based in New Jersey.