CTN Gender SIG

Chairs: Shelly Greenfield, MD and Aimee Campbell, PhD

Meetings: Monthly – 2nd Wednesday, 1:00-2:00 pm ET

The Clinical Trials Network (CTN) Gender Special Interest Group (GSIG) is a resource to provide consultation to members of the CTN regarding gender-related issues in the development, planning, execution, and analysis of current and new studies. Members of the GSIG help identify critical areas of investigation pertaining to substance use disorder (SUD) treatment for women (including adolescent girls and transgender women), and other gender diverse people (e.g., non-binary individuals) historically underrepresented in and excluded from research trials. The GSIG has developed concepts, conducted secondary data analyses, and critical reviews pertaining to sex and gender differences and gender-related issues in SUD treatment. In addition, the GSIG offers consultation to members of the CTN regarding incorporating gender-related issues in the design and analysis of new protocols. The goal is to provide advice and consultation during the development of a new protocol such that specific issues relating to recruitment, retention, assessment, treatment, and outcomes for women with substance use disorders could be incorporated into the design of any given study. In addition, the GSIG offers consultation regarding the development of a data analytic plan that would accommodate a specific sample of women and gender diverse participants, analyses of sex and gender differences, and/or analyses of differences among subgroups of women participants, including racial/ethnic, socioeconomic, and co-occurring mental health experiences. The GSIG also develops symposia and workshops for presentation at national conferences and often collaborates on papers that synthesize CTN trial data and reviews of the literature pertaining to sex and gender outcomes and differences.

Inclusion of women and other gender diverse people in the study sample, gender-sensitive assessments and questionnaires, as well as data analytic plans that incorporate analyses of gender differences are consistent with the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research updated August 1, 2000 (http://grans1.nih.gov/grants/funding/women min/guidelines update.htm). These NIH guidelines state that Principal Investigators “should assess the theoretical and/or scientific linkages between gender, race/ethnicity, and their topic of study.”  The guidelines further specify that there should be “allocation of study participants of both sexes/genders (males and females) and from different racial/ethnic groups to the intervention and control groups by an unbiased process, …unbiased evaluation of the outcomes(s) of study participants,” and “use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the gender and racial/ethnic groups.”

The GSIG provides informal discussion, consultation, and advice regarding any or all of the following:

  • Identifying critical “gaps” in our current knowledge base regarding substance use disorder treatment, early identification, and prevention for women.
  • Any pertinent results from the existing GSIG conducted literature review of predictors of outcome for women in substance use treatment or gender differences related to SUD and/or treatment.
  • Gender-specific issues regarding recruitment and retention of subjects.
  • Gender-specific and gender-sensitive assessment measures and/or questions to add to standard measures including the common assessment battery for women participants.
  • Gender-specific or gender-sensitive aspects of treatment programming and/or assessment of outcomes.
  • How intersecting marginalized identities (e.g., on the basis of racial, ethnic, and/or gender identity) impact substance use outcomes.
  • Methods of data analysis with respect to stratification on gender or analyses by gender.

Interested in joining this SIG?
Contact SIG Chairs Shelly Greenfield, MD or Aimee Campbell, PhD