The representation of females in clinical trials for substance use disorder conducted in the United States (2010–19)

Background Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. Methods A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literature search on sex and gender policies in scientific publishing. Results The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. Conclusions The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process. Show more

This paper reviews the literature examining characteristics associated with treatment outcome in women with substance use disorders. A search of the English language literature from 1975 to 2005 using Medline and PsycInfo databases found 280 relevant articles. Ninety percent of the studies investigating gender differences in substance abuse treatment outcomes were published since 1990, and of those, over 40% were published since the year 2000. Only 11.8% of these studies were randomized clinical trials. A convergence of evidence suggests that women with substance use disorders are less likely, over the lifetime, to enter treatment compared to their male counterparts. Once in treatment, however, gender is not a significant predictor of treatment retention, completion, or outcome. Gender-specific predictors of outcome do exist, however, and individual characteristics and treatment approaches can differentially affect outcomes by gender. While women-only treatment is not necessarily more effective than mixed-gender treatment, some greater effectiveness has been demonstrated by treatments that address problems more common to substance-abusing women or that are designed for specific subgroups of this population. There is a need to develop and test effective treatments for specific subgroups such as older women with substance use disorders, as well as those with co-occurring substance use and psychiatric disorders such as eating disorders. Future research on effectiveness and cost-effectiveness of gender-specific versus standard treatments, as well as identification of the characteristics of women and men who can benefit from mixed-gender versus single-gender treatments, would advance the field. Show more