Accelerating start-up cycles in investigator-initiated multicenter clinical trials.

ABSTRACT:

Background

Operational roadblocks and organizational delays in multicenter clinical trials have been evident for decades, with the start-up cycle being especially notorious for setbacks. To address these challenges and improve multicenter clinical trial execution, we developed an accelerated start-up (ASU) management strategy - a structured site onboarding approach based on lean management principles.

Methods

Three elements were integrated into the strategy: a standardized workflow, a dedicated site navigator (SN), and an electronic tracking system. We examined the range, central tendencies, and distribution of site activation times among differing combinations of these three elements. To determine how these combinations affected individual start-up milestones, we fit mixed

SUBMITTER: Hillery S 

PROVIDER: S-EPMC12695510 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature