Leukemia & lymphoma · 2024
Analyzing determinants of premature trial discontinuation in leukemia clinical trials.
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Rotter Lara K, Alhajahjeh Abdulrahman, Stempel Jessica M, Grimshaw Alyssa A, Bewersdorf Jan Philipp, Blaha Ondrej, Kewan Tariq, Podoltsev Nikolai A, Shallis Rory M, Mendez Lourdes, Stahl Maximilian, Zeidan Amer M
Аннотация
Clinical trials are crucial for improving patient outcomes. Although a significant number of trials are discontinued prematurely, our understanding of factors influencing early termination is limited. We conducted a comprehensive search of ClinicalTrials.gov to identify leukemia trials from 2000 to 2020, followed by data abstraction performed by two independent reviewers. Among 3522 leukemia clinical trials identified, 28.4% were terminated prematurely. Slow accrual was the leading cause of termination 38.2%. The termination rate increased significantly from 17.0% between 2000 and 2005 to 30.9% between 2010 and 2015 (p < .001). Large trials had a lower termination rate than small trials (p < .001). Academic-sponsored trials had the highest termination rates compared to other sponsors' trials (p < .001). Early-phase trials showed higher termination rates compared to late-phase (p < .001). Other significant factors included a sequential assignment, single-center, and non-randomized trials (p < .001). Much of leukemia trials are terminated prematurely, with slow accrual being the most common reason for early termination.