Analyzing determinants of premature trial discontinuation in leukemia clinical trials
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 (<i>p</i> < .001). Large trials had a lower termination rate than small trials (<i>p</i> < .001). Academic-sponsored trials had the highest termination rates compared to other sponsors' trials (<i>p</i> < .001). Early-phase trials showed higher termination rates compared to late-phase (<i>p</i> < .001). Other significant factors included a sequential assignment, single-center, and non-randomized trials (<i>p</i> < .001). Much of leukemia trials are terminated prematurely, with slow accrual being the most common reason for early termination.
Authors
- Alyssa Grimshaw (ORCID: https://orcid.org/0000-0003-3985-0056)
- Maximilian Stahl (ORCID: https://orcid.org/0000-0002-1299-5901)
- Nikolai Alexandrovich Podoltsev (ORCID: https://orcid.org/0000-0002-3657-778X)
- Tariq Zuheir Kewan (ORCID: https://orcid.org/0000-0003-4651-5125)
- Jessica M. Stempel (ORCID: https://orcid.org/0000-0001-9162-0579)
- Ondřej Bláha (ORCID: https://orcid.org/0000-0003-3665-3276)
- Abdulrahman Alhajahjeh (ORCID: https://orcid.org/0000-0001-5264-8990)
- Amer Methqal Zeidan (ORCID: https://orcid.org/0000-0001-7017-8160)
- Lourdes Mendez (ORCID: https://orcid.org/0000-0002-5922-2877)
- Jan Philipp Bewersdorf (ORCID: https://orcid.org/0000-0003-3352-0902)
- Rory Michael Shallis (ORCID: https://orcid.org/0000-0002-8542-2944)
- Lara K. Rotter (ORCID: https://orcid.org/0009-0009-0886-9919)
Institutions
- University of Jordan (JO)
- Yale New Haven Hospital (US)
- Memorial Sloan Kettering Cancer Center (US)
- Harvard University (US)
- King Hussein Cancer Center (JO)
- Yale Cancer Center (US)
- Yale University (US)
- Dana-Farber Cancer Institute (US)
Publication Details
- Journal
- Leukemia & lymphoma/Leukemia and lymphoma
- Published
- 2024-10-23
- DOI
- https://doi.org/10.1080/10428194.2024.2416565
- Citations
- 3
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 2.13