Analyzing determinants of premature trial discontinuation in leukemia clinical trials Journal Article


Authors: Rotter, L. K.; Alhajahjeh, A.; Stempel, J. M.; Grimshaw, A. A.; Bewersdorf, J. P.; Blaha, O.; Kewan, T.; Podoltsev, N. A.; Shallis, R. M.; Mendez, L.; Stahl, M.; Zeidan, A. M.
Article Title: Analyzing determinants of premature trial discontinuation in leukemia clinical trials
Abstract: 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. © 2024 Informa UK Limited, trading as Taylor & Francis Group.
Keywords: controlled study; treatment outcome; leukemia; chronic myelomonocytic leukemia; major clinical study; comparative study; chronic myeloid leukemia; myelodysplastic syndrome; total quality management; prematurity; chronic lymphatic leukemia; clinical trials; quality improvement; blast cell crisis; early termination; acute myeloid leukemia; hematological malignancy; human; article; high income country
Journal Title: Leukemia and Lymphoma
Volume: 66
Issue: 2
ISSN: 1042-8194
Publisher: Taylor & Francis Group  
Date Published: 2025-01-01
Start Page: 289
End Page: 297
Language: English
DOI: 10.1080/10428194.2024.2416565
PUBMED: 39440622
PROVIDER: scopus
DOI/URL:
Notes: Source: Scopus
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