The Role of Diverse Populations in US Clinical Trials

Abstract

Effective clinical trials are meant to provide the safest and fastest way to find new treatments to improve health. The FDA affirms that because people may respond differently to treatments, it is imperative to test drugs and medical products in a variety of populations (https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials). Unfortunately, clinical trial enrollment in the US remains largely homogeneous, with the majority of participants being non-Hispanic white men. Despite efforts to increase diversity in recruitment for clinical trials, enrollment of racial/ethnic minorities in this nation has decreased over the past two decades.¹.