© CZARDASES/ISTOCKPHOTO.COMClinical trials were traditionally conducted using predominately white male subjects. However, the 1993 National Institutes of Health (NIH) Revitalization Act required that all NIH-funded research involving human subjects, including clinical trials, have as diverse a participant cohort as possible, unless there were strongly justifiable reasons to do otherwise (e.g., limiting the study of uterine cancer to female subjects). One of the most significant advantages to the inclusion of diversity in clinical studies is that it enables the early detection of differences in the safety and efficacy of interventions among heterogeneous patient subgroups.
Most clinical trials, as well as large observational studies, now perform an elaborate set of statistical adjustments to account for the impact of key cohort characteristics such as age, gender, and race/ethnicity on study outcomes. Despite these sophisticated analyses, it is still uncertain whether these characteristics can accurately predict treatment response in an individual patient. While age and gender are strongly associated with biological differences that may have a significant impact on disease susceptibility and treatment response—and are thus carefully controlled for, sometimes by excluding certain groups such as children and/or elderly from trials—the role of race/ethnicity is far less clear. Indeed, unlike the case with age or gender, race has no consensus criteria for definition.
The concept of race has been widely propagated since ...
