Supporting Seamless Execution Across Early Phase Alzheimer's Trials
This case study examines the operational challenges of managing multi-site early-phase Alzheimer's clinical trials during the COVID-19 pandemic. It highlights how streamlined oversight and improved communication helped the program meet its timeline and budget goals.
Why it matters
Effective clinical trial management is critical for accelerating the delivery of life-saving treatments to patients with neurodegenerative diseases.
Advancing a novel Alzheimer's treatment through three consecutive early-phase studies across 18 sites is a complex undertaking under any circumstances. During the COVID-19 pandemic, the program faced compounding obstacles, including participant hesitancy to enroll, inefficiencies introduced by intermediary consultant layers, high turnover among vendor support staff, and compressed timelines for single- and multiple-ascending-dose studies.
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