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

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.

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 models to compare percent achievement of predetermined milestone benchmarks and time to completion.

Thirteen consecutive trials (n = 308 site activations) employed three distinct combinations of the three ASU elements. Trials using all three elements (n = 6) had 160 total site activations in a median of 133 days. Three trials without the SN element had 52 total site activations in a median of 191 days. Four trials without the standardized workflow element had 96 total site activations in a median of 277 days. Significant differences between combinations included times to sIRB submission (p = 0.004), training/certificates completion (p = 0.03), and site activation (p = 0.003). Results suggest sites activated faster and achieved predetermined benchmarks for every milestone more often when three elements were employed.

This sample trial start-up data supports that sites can meet ambitious timelines, underscoring the strategy's potential to streamline workflows and improve site team performance.