title: Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress?
abstract: BACKGROUND
  The National Institutes of Health (NIH) Revitalization Act of 1993 requires that NIH-funded clinical trials include women and minorities as participants; other federal agencies have adopted similar guidelines. The objective of this study is to determine the current level of compliance with these guidelines for the inclusion, analysis, and reporting of sex and race/ethnicity in federally funded randomized controlled trials (RCTs) and to compare the current level of compliance with that from 2004, which was reported previously.
  
  
  METHODS
  RCTs published in nine prominent medical journals in 2009 were identified by PubMed search. Studies where individuals were not the unit of analysis, those begun before 1994, and those not receiving federal funding were excluded. PubMed search located 512 published articles. After exclusion of ineligible articles, 86 (17%) remained for analysis.
  
  
  RESULTS
  Thirty studies were sex specific. The median enrollment of women in the 56 studies that included both men and women was 37%. Seventy-five percent of the studies did not report any outcomes by sex, including 9 studies reporting <20% women enrolled. Among all 86 studies, 21% did not report sample sizes by racial and ethnic groups, and 64% did not provide any analysis by racial or ethnic groups. Only 3 studies indicated that the generalizability of their results may be limited by lack of diversity among those studied. There were no statistically significant changes in inclusion or reporting of sex or race/ethnicity when compared with 2004.
  
  
  CONCLUSIONS
  Ensuring enhanced inclusion, analysis, and reporting of sex and race/ethnicity entails the efforts of NIH, journal editors, and the researchers themselves.
authors.affiliation: Center for Research on Women and Gender, University of Illinois at Chicago, College of Medicine, 820 S. Wood Street, Chicago, IL 60612, USA. sgeller@uic.edu
authors.forename: Stacie E
authors.initials: SE
authors.lastname: Geller
authors.forename: Abby
authors.initials: A
authors.lastname: Koch
authors.forename: Beth
authors.initials: B
authors.lastname: Pellettieri
authors.forename: Molly
authors.initials: M
authors.lastname: Carnes
mesh_terms: D005006:Ethnicity / Q000706:statistics & numerical data*; D019317:Evidence-Based Medicine / Q000592:standards / Q000706:statistics & numerical data*; D005260:Female; D019983:Guideline Adherence / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008913:Minority Groups / Q000706:statistics & numerical data*; D009316:National Institutes of Health (U.S.); D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012109:Research Support as Topic; D014481:United States; D016387:Women's Health