14 Aug Optimized Design Offers Fast Track to Inclusive Clinical Trials

By Faith Holmes, ACRP

Diversity in clinical research has become a hot topic in recent years, with heightened attention leading to dramatic changes in the regulatory framework, including U.S. legislation broadening the scope of diversity consideration in clinical trials. In an article for the forthcoming August issue of ACRP’s Clinical Researcher journal, Faith Holmes, MD, Chief Medical Officer, and Kristen Snipes, CCRA, Executive Director, Project Delivery, both with Elligo Health Research®, examine how, despite this increased awareness and regulatory push, many long-standing challenges persist. The same barriers that have historically hindered diverse participation in clinical research continue to pose significant obstacles, they write.

“These persistent barriers are reflected in clinical trial participation statistics,” the authors note. “Approximately 10.6% of participants are Black/African American compared to representing 12.6% of the U.S. adult population. Hispanic/Latino representation in clinical trials is approximately 11.6% compared to 16.7% of the population. Conversely, White participants are overrepresented, making up 77.9% of trials and 74.1% of the population. Although numerous factors contribute to these statistics, the most crucial one is arguably the ongoing lack of minority accessibility to research.” Read more…