Advancing Clinical Research In 2025: Meeting FDA Standards In Decentralized Trials

In September 2024, the FDA released finalized guidance on decentralized clinical trials (DCTs), underscoring the importance of participant safety, data integrity, and patient-centric approaches. This guidance aligns with the mission of 20/20 Onsite, a leader in point-of-need vision services, and emphasizes innovative trial models that enhance accessibility and engagement. Key components of the guidance include the use of Mobile Research Units (MRUs), which facilitate local healthcare provider involvement and minimize participant burden through reduced travel and administrative demands.

The FDA also advocates for equitable trial access via digital health technologies and tailored solutions, such as Mobile Vision Clinics, to overcome geographic and technological barriers. Furthermore, the guidance highlights the critical need for comprehensive monitoring plans to ensure data accuracy and participant safety in decentralized settings. Overall, the FDA's guidance promotes participant-centric designs that are vital for the evolution of clinical research, positioning 20/20 Onsite as a pivotal partner in enhancing recruitment, retention, and diversity in clinical trials while aligning with regulatory expectations.