Chapter 12 - Sex bias in surgical research

Abstract

Sex bias has been shown to exist in research despite the knowledge that men and women experience disease and respond to treatment differently. It is well established that sex bias in research is prevalent across medical specialties including surgery. Data extrapolation to both sexes despite inadequate female representation in studies ultimately leads to the development of drugs and devices that cause more adverse events in women compared with men. The historical reasons for sex bias in research are multifactorial and include traditional use of male-only subjects as well as misconceptions about the female estrous cycle and concerns of safety in childbearing-aged women. Sex bias still exists today in surgical research and has been demonstrated across multiple surgical specialties from the levels of basic and translational research to clinical research. There are now requirements for sex-inclusive research at the level of funding organizations such as the National Institutes of Health (NIH), as well as at the publication level with journals and editors. With these efforts to address sex bias in research and bridge the gap it has created, some progress has been made resulting in better female participation in clinical trials. But sex bias remains an issue especially at the preclinical level and in early phase clinical trials where there is still poor sex matching and sex-based reporting and analysis of data. Translation of research to improve the health of all people will remain limited until these sex-biased practices are abolished.