Decentralized community-integrated research sites drive higher randomization rates: insights from a large-scale neurodegenerative disease trial

DCIR sites exhibited superior participant screening and randomization efficiency while maintaining discontinuation rates comparable to traditional site models. This success was driven by a combination of innovative operational strategies, including decentralized community-based outreach mechanisms that expanded population access to research by bringing trials directly to populations that previously lacked access to clinical research. At the same time, this approach helped reach underrepresented groups, thereby improving both geographic coverage and trial generalizability while enhancing overall trial performance. Additionally, other innovations like the deployment of centralized remote research coordinators also played a role by streamlining remotely-conducted tasks, allowing site staff, in all site models, to focus on participant care and engagement. These findings highlight the effectiveness of a flexible, multi-model site strategy in addressing recruitment and retention challenges in large-scale Phase 3 neurodegenerative disease trials and suggest that this approach may extend to other therapeutic areas facing similar challenges.