Ensuring that the fruits of clinical trial research translate to equitable care

The persistence of health care disparities for disadvantaged populations in the United States is undisputed; elimination of these disparities is a high priority.¹ A landmark report from a Task Force of the Secretary of Health and Human Services documented higher mortality and burden of disease in minorities.² These data, as well as growing recognition of underrepresentation of women subjects in clinical research, prompted the NIH in 1986 to encourage the inclusion of women and minorities in clinical research. In 1993, the National Center for Minority Health and Health Disparities was established, recently redesignated as an Institute; Congress passed the NIH Revitalization Act, and the NIH subsequently implemented a revised policy that ensured inclusion of women and minorities in NIH-funded clinical research, specifying that their inclusion in phase III clinical trials be adequate in size to determine if gender or race/ethnicity subgroups had differential responses to the treatment being tested. NIH has since monitored these policies' effectiveness. In 2000, a new requirement for phase III clinical trials was the inclusion of a plan to conduct these subgroup or “valid” analyses by gender and by race/ethnicity, or a justification—exclusive of cost—as to why not, which must pass muster in peer review. Guidance for implementation of these requirements was formalized.³ Enrollment by gender and by race/ethnicity in National Institute of Neurological Disorders and …