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.”
Innovative trial design is key to improving research accessibility, according to Holmes and Snipes, specifically through the concept of optimized trials, defined as virtual clinical trials designed to create ideal conditions for both patients and sponsors.
In an optimized trial scenario, “Patients have simple, effective, and comfortable access to research as a care option, while sponsors can quickly and easily enroll and retain eligible, engaged patients,” the authors write. “This approach to trial design prioritizes patient experience and accessibility, which in turn can significantly increase access to research participation for traditionally underrepresented communities. By reimagining how clinical trials are conducted, optimized trials have the potential to break down many of the barriers that have historically limited minority participation in research.”
Noting that research diversity is not only a matter of fairness; it’s fundamental to producing robust, inclusive, and impactful treatments that benefit all people, the authors add, “Simply put, when clinical trials achieve greater diversity, they accelerate progress in medical research and treatment development. By breaking down barriers and creating more inclusive research environments, we can ensure that the benefits of scientific advancement are accessible to all communities.”
In addition to this and other timely columns on hot topics in the field, the August 2024 issue of Clinical Researcher will include peer-reviewed articles on traveling the clinical research associate career pathway, measuring the impacts of decentralized clinical trials on quality management, participant outcomes, and data management, and exploring the role of multi-omics in enhancing cancer clinical trials.
Edited by Gary Cramer
