Sex and race/ethnicity reporting in clinical trials: a necessity, not an option.

Even though slightly over half of the population of the United States are women and over one third of the population are people of color, information about the health of women and people of color remains woefully inadequate. Nearly 20 years ago, the National Institutes of Health (NIH) created standards for the inclusion of women and minorities in clinical trials as well as mandated annual reporting of race, ethnicity, and sex in annual progress reports. With increased government support and growing awareness among healthcare professionals, some progress had been made in terms of enrolling greater numbers of woman and people of color in clinical trials and in trial publication reporting of sex and race=ethnicity-specific results. Nevertheless, women and people of color are still underrepresented in clinical trials, and only a minority of studies report results by sex, race= ethnicity, or both. In this issue of Journal of Women’s Health, Geller et al. provide an update of their previous study, assessing the rate of sex and race=ethnicity-specific result reporting in randomized controlled trials during 2004. Eighty-six federally funded studies published in nine selected journals during 2009 were assessed for inclusion of women and people of color as well as for analysis and reporting of sex and race=ethnicity-specific results. The median percent of women enrolled in non-sex-specific studies was 38%. Of the 52 studies that included more than one racial=ethnic group, white subjects comprised 10%–99% of the participants. Only 25% of the studies reported sex-specific results, and only 46% of the studies analyzed the results by racial or ethnic groups. These results are unchanged from results reported in the previous study by Geller et al. Despite the creation of guidelines for the enrollment of women and minorities in NIH-sponsored research and the stipulation that annual research progress reports include analysis of results by sex, race, and ethnicity, the study by Geller et al. demonstrates that women and people of color continue to be underrepresented in clinical trials and that sex and race=ethnicity-specific results are still infrequently reported. These disparities have caused a persistent knowledge gap about sex and race=ethnicity differences in a wide range of diseases, including cardiovascular disease, cancer, stroke, and chronic lower respiratory diseases, the four leading causes of death in the United States. This, in turn, limits our ability to establish appropriate guidelines for the prevention, diagnosis, and treatment of a multitude of diseases and obscures our understanding of differences in outcomes. Several study features limit the impact of the findings of Geller et al. Of significance, this study evaluated only a small minority of NIH-sponsored clinical trials that were published in selected journals. Is the onus for the lack of sex and race=ethnicity reporting on the researchers, the NIH, or the publishers of the prespecified journals? In addition, this report examined studies only in the areas of general internal medicine, oncology, cardiology, infectious disease, and obstetrics=gynecology. The inclusion of studies pertaining to other medical specialties or subspecialites may have altered the results. Interestingly, a recent study analyzing the enrollment of women and people of color in the National Institute of Neurological Disorders and Stroke (NINDS) found that the enrollment of women and African Americans in these studies has increased over time, whereas the enrollment of Hispanic Americans has decreased. Perhaps most importantly, this study focused primarily on federally funded studies, which represent a minority of clinical trials performed in the United States. Although the inclusion of women and minorities and appropriate sex and race=ethnicity-specific reporting is not mandated in nonfederally funded trials, the rationale for these mandates has been clearly stated and repeatedly emphasized to the point where lack of awareness cannot justify lack of voluntary adherence to these mandates in all clinical studies unless there is a compelling reason why this is not feasible. Women, men, and people of color must be entered into clinical trials and registries in sufficient numbers to adequately address sex and racial=ethnic differences. Stricter enforcement of existing federal guidelines is crucial but will not solve the problem. Researchers and private funding sources must establish and adhere to policies for inclusion and reporting that align with federal mandates. Mechanisms for increasing the recruitment of women and people of color in trials, including active targeting of these specific groups and elimination of barriers to participation that disproportionately affect women and people of color must be devised and implemented. The enactment and enforcement of publication policies requiring that sex and race=ethnicity-specific results be reported will likely increase the incidence of such result reporting. Several medical journals have recently enacted such policies, but the impact of these policies remains to be seen.