The FDA Wants Improved Clinical Trial Diversity. Here's How Patient Engagement And Recruitment Services Can Help.

The FDA Omnibus Reform Act of 2022 (FDORA), enacted in December of the same year, encompasses a wide range of clinical research directives, covering decentralized trials, BIMO inspections, accelerated approvals, and more. However, its most significant change revolves around the FDA's mandate for diversity in clinical trials.

Under FDORA, the FDA has broadened its diversity scope beyond race and ethnicity to include factors such as sex, gender identity, age, socioeconomic status, disability, and others. It now requires diversity action plans for clinical trials, obligating sponsors to define diverse patient enrollment goals, justify these goals, and outline strategies for achieving them.

Navigating this heightened diversity focus alongside the existing challenges of clinical trial enrollment can seem daunting for sponsors. How can one effectively recruit patients from diverse demographics?