FDA takes steps towards diversity in clinical trials

By Dr Nicola Davies

Genetic differences among racial and ethnic populations can lead to differences in the safety and efficacy of drugs across these populations. The US Food and Drug Administration approves medical products based on evidence from clinical trials and so participants in clinical trials should adequately represent the population intended to use the product.

Given the increasing diversity of the US population, diverse trial participation has become even more critical.1 However, several challenges hinder adequate enrollment of underrepresented populations, including: mistrust in the clinical research sector due to historical abuse of racial and ethnic populations;  insufficient efforts by the clinical research system towards recruitment and retention; difficulty in transportation or participation due to family or caregiver responsibilities; lack of awareness regarding clinical trial participation; and, language and cultural barriers.1