Innovative design and modelling to improve sex and gender analysis in clinical trials

Abstract

Jane Hirst and colleagues argue that novel modelling approaches using routinely collected data can be only as representative and complete as the original data, and that bridging the sex and gender gap through contemporary, innovative clinical trial designs could be a crucial way forward Although women represent half of the world’s population, they comprise fewer than half of the participants in clinical trials. This has created gaps in knowledge about women’s health, as well as how sex and gender affect health outcomes for everyone.1 For this article, part of the BMJ Collection on Women’s Health Innovation (www.bmj.com/collections/womens-health-innovation), we use definitions of sex and gender as outlined by the MESSAGE project (box 1).2 Historically, self-reported gender has been missing from data collection, with sex captured in a binary manner.3 Ultimately, we view the solutions presented in this article as components of a broader toolkit necessary to begin to represent the complexity of sex and gender in data collection, analysis, and interpretation to influence clinical practice. However, we recognise that modifications or expansions of the toolkit may be needed to ensure adequate consideration of the broader sociocultural constructs relevant to gender, sex and gender interactions, and other intersectional factors. Box 1 ### Definitions of sex and gender2 The terms sex and gender are understood differently in different contexts, societies, groups, and languages. The use of these terms has changed over time and will continue to evolve.RETURN TO TEXT