• Mary A Foulkes.
• 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
• J Womens Health (Larchmt). 2011 Jun 1; 20 (6): 829-36.

ObjectiveThe 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.MethodsFor 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.ResultsPublications 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.ConclusionsEfforts 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.

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