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.