title: After inclusion, information and inference: reporting on clinical trials results after 15 years of monitoring inclusion of women.
abstract: OBJECTIVE
  The objectives of this report are to review the publications resulting from National Institutes of Health (NIH)-funded phase 3 trials monitored by NIH for inclusion and to address the quality of the research conducted and the validity of the sex/gender-specific or sex/gender difference analyses reported.
  
  
  METHODS
  For intervention trials enrolling both women and men, this review links reports to NIH of completed enrollment to publications of trial results. Each publication was then reviewed for a variety of reported characteristics based on established measures of quality, bearing on whether or not the research will permit valid analyses of sex/gender differences.
  
  
  RESULTS
  Publications from 268 trials reported an overall average enrollment of 37% (±6% standard deviation [SD]) women, at an increasing rate over the years 1995-2010. Only 28% of the publications either made some reference to sex/gender-specific results in the text or provided detailed results including sex/gender-specific estimates of effect or tests of interaction.
  
  
  CONCLUSIONS
  Efforts at including women in clinical research have increased the information captured relative to women's health. Sex/gender-specific information has been captured and should be available to other researchers for further analysis, including individual patient data meta-analyses. Improved reporting and disseminating sex/gender-specific results will allow sex/gender-specific inferences and healthcare decisions.
authors.affiliation: Departments of Epidemiology and Biostatistics and Health Policy, The George Washington University, Biostatistics Center, 6110 Executive Boulevard, Rockville, MD 20852-3943, USA. mfoulkes@bsc.gwu.edu
authors.forename: Mary A
authors.initials: MA
authors.lastname: Foulkes
mesh_terms: D015706:Bibliometrics; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D009316:National Institutes of Health (U.S.) / Q000331:legislation & jurisprudence; D035842:Research Subjects; D017678:Sex Distribution; D014481:United States; D016387:Women's Health