Abstract
Decentralized clinical trials incorporating telehealth visits, home visits by remote personnel, and local healthcare provider involvement can reduce participant burden without relocating all activities from traditional research sites, according to FDA September 2024 final guidance. Trial design must balance convenience against safety, measurement quality, and participant support. A hybrid model allows appropriate activities in different settings while maintaining oversight and data integrity. Design considerations include identifying which visits require site attendance, clarifying logistics and equipment needs, and testing instructions with intended users. Convenience involves more than travel reduction; it encompasses total burden including tasks transferred to home settings, such as device management, software use, and privacy requirements. Access depends on measurable factors including awareness, eligibility, enrollment patterns, and retention across populations. Operational processes must ensure measurement validity, identify data collection failures, and enable follow-up when issues occur. The substantive value of home-based trial elements emerges from participant feedback on which burdens decreased and which new ones appeared, indicating whether decentralized activities actually improved participation feasibility. Executive implication: decentralized trials require rigorous design around observed participant needs rather than assumed convenience, with dependable data collection pathways supporting the research relationship across multiple settings.
Read the complete research: When the Clinical Trial Comes Home.