THE IMPORTANCE OF RACIAL and ethnic minority participation in clinical research has been well established including, but not limited to, generalizability of research findings, equity in provision of health care, and accuracy of ethnicity-specific subgroup analyses. Despite a series of national-level initiatives in the past 2 decades from the National Institutes of Health, the Federal Drug Administration (FDA), and the Centers for Medicare and Medicaid Services, racial and ethnic minorities remain underrepresented in clinical research. Racial/ethnic minorities constitute more than 30% of the US population, but enrollment by race/ethnicity of National Cancer Institute publicly funded cancer clinical trials (phase I–III treatment studies, January 1, 2003, through June 30, 2005) revealed that they represented less than 18% of clinical trial participants.
