We've come a long way, maybe: Recruitment of women and analysis of resultsby sex in clinical research

During the last decade, North American policymakers have started to demand more representative research populations. Several papers have suggested tha t there has been improvement, over the last decade, in the number of studie s that include women as subjects, yet these same papers have expressed conc ern that many investigators omit analysis of data by sex from their researc h reports. Our study examined all clinical research ethics applications fro m July 1, 1995, to June 30, 2000, at a tertiary care Canadian university te aching hospital to determine whether the investigator planned to recruit bo th men and women and whether he or she intended to perform analysis of data by sex. For research studying nonsex-specific conditions, 97.6% of researc hers intended to recruit both men and women, yet only 20.2% planned to perf orm analysis of data by sex. This proportion decreased from 29.9% in 1995-1 996 to 16.9% in 1999-2000. Seventy-seven percent of the applications submit ted were for studies involving drugs, and only 17% of these nonsex-specific studies planned an analysis of data by sex. The results of this study indi cate that although researchers in Canada are aware of the importance of pla nning to recruit women into clinical trials, more needs to be done to ensur e that they plan and perform analyses of data by sex.