Enhancing representation of special populations: An approach to the inclusion of women veterans in VA clinical trials.

Abstract

The under-recruitment of historically marginalized populations into clinical trials thwarts equitable inclusion of individuals who could benefit from healthcare innovations and limits the generalizability of results. For decades, the Veterans Health Administration (VA) has conducted large clinical trials that impact clinical guidelines for veterans and civilians alike. Within the VA, women are a numeric minority, and recruitment of this population into trials is challenged by gender-specific care structures, distinct demographic characteristics, and mistreatment such as higher rates of military sexual trauma and harassment on VA grounds. We describe our approach to enhancing the inclusion of women veterans in clinical trials through the VA Women's Enhanced Recruitment Program (WERP) as developed for the VA Cooperative Studies Program. This information is relevant to clinical trial teams seeking to include women veterans in their trials. Our findings also have implications for other researchers seeking equitably increase participation of marginalized populations so that findings are generalizable to broader populations.