Practical Strategies For Ensuring A Diverse Patient Population In Clinical Trials

The FDA's 2025 initiative to improve patient recruitment in clinical trials by mandating Diversity Action Plans (DAPs), aims to address how medications affect diverse populations by enhancing the participation of underrepresented communities. The FDA's guidance, expected by June 2025, will require companies to set and monitor enrollment goals based on ethnicity, race, sex, and age, employing strategies like community engagement and flexible study hours.

Recruitment challenges can be exacerbated by complex protocols and a shortage of experienced professionals post-COVID. Companies are leveraging grassroots outreach and technology, including AI, to identify participants. Regulatory changes will enforce diversity across all trials, prompting companies to prioritize inclusive strategies. Decentralized trials and strategic site selection are suggested to overcome participation barriers. The FDA's guidance is seen as a positive step, despite potentially slowing recruitment, encouraging the industry to rethink strategies to ensure equitable access to clinical trials and treatments for all individuals.