The Impact Of FDORA On Clinical Trial Diversity

The FDA Omnibus Reform Act (FDORA), implemented over a year ago, has reshaped the clinical trial industry's focus on diversity, promoting a more inclusive approach beyond race and ethnicity to encompass gender identity, age, and socioeconomic status. This legislation requires diversity action plans in clinical trials, aligning with precision medicine and encouraging innovative strategies like decentralized clinical trials (DCTs) and diversity-based site selection. Despite these advancements, challenges such as health literacy, language barriers, and physical access to trials persist. Regulatory obstacles, including multistate licensure and DCT guidelines, further complicate efforts to enhance diversity. Addressing these issues may involve developing strategies to accommodate mobility challenges and ensuring trial materials are accessible in multiple languages. Sponsors are urged to design trials with a participant-centric approach, prioritize patient experience, and embrace innovative methods over traditional ones. Although artificial intelligence offers the potential for improving diverse enrollment, regulatory bodies, and sponsors are still adapting to its application. Take a deeper look into how FDORA is serving as a catalyst for change, promoting a more inclusive and equitable landscape in clinical research.