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Analysis of factors leading to early termination in glioblastoma-related clinical trials

PURPOSE: Terminated clinical trials are an inefficient use of financial, patient, and administrative resources. We reviewed ClinicalTrials.gov for completed and terminated clinical trials for glioblastoma multiforme (GBM) and compared reported characteristics of completed and terminated trials to id...

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Autores principales: Shah, Harshal A., Mishra, Akash, Gouzoulis, Michael J., Ben-Shalom, Netanel, D’Amico, Randy S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9158304/
https://www.ncbi.nlm.nih.gov/pubmed/35648307
http://dx.doi.org/10.1007/s11060-022-04039-y
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author Shah, Harshal A.
Mishra, Akash
Gouzoulis, Michael J.
Ben-Shalom, Netanel
D’Amico, Randy S.
author_facet Shah, Harshal A.
Mishra, Akash
Gouzoulis, Michael J.
Ben-Shalom, Netanel
D’Amico, Randy S.
author_sort Shah, Harshal A.
collection PubMed
description PURPOSE: Terminated clinical trials are an inefficient use of financial, patient, and administrative resources. We reviewed ClinicalTrials.gov for completed and terminated clinical trials for glioblastoma multiforme (GBM) and compared reported characteristics of completed and terminated trials to identify factors associated with early trial termination. METHODS: ClinicalTrials.gov was queried to identify all completed and terminated GBM-related clinical trials. Trial characteristics were examined and the reason for trial termination was determined. Univariate analysis by Pearson’s chi-square and a multivariate logistic regression were performed to identify independent predictors of early trial termination. RESULTS: We identified 886 completed and terminated GBM-related trials between 2003 and 2020. Of these, 175 (19.8%) were terminated prior to completion. The most common reason for termination was participant accrual difficulties, accounting for 63 (36.0%) terminated trials. Trial termination was associated with trials that reported a primary purpose of diagnosis relative to treatment (OR = 2.952, p = 0.001). CONCLUSION: Early termination of clinical trials investigating interventions for the treatment of GBM is associated with diagnostic trials relative to therapeutic trials. Patient accrual difficulties are the most commonly identified reason for early trial termination. Predictors of trial termination should be considered when designing GBM-related clinical trials to minimize the odds of early trial termination.
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spelling pubmed-91583042022-06-02 Analysis of factors leading to early termination in glioblastoma-related clinical trials Shah, Harshal A. Mishra, Akash Gouzoulis, Michael J. Ben-Shalom, Netanel D’Amico, Randy S. J Neurooncol Review PURPOSE: Terminated clinical trials are an inefficient use of financial, patient, and administrative resources. We reviewed ClinicalTrials.gov for completed and terminated clinical trials for glioblastoma multiforme (GBM) and compared reported characteristics of completed and terminated trials to identify factors associated with early trial termination. METHODS: ClinicalTrials.gov was queried to identify all completed and terminated GBM-related clinical trials. Trial characteristics were examined and the reason for trial termination was determined. Univariate analysis by Pearson’s chi-square and a multivariate logistic regression were performed to identify independent predictors of early trial termination. RESULTS: We identified 886 completed and terminated GBM-related trials between 2003 and 2020. Of these, 175 (19.8%) were terminated prior to completion. The most common reason for termination was participant accrual difficulties, accounting for 63 (36.0%) terminated trials. Trial termination was associated with trials that reported a primary purpose of diagnosis relative to treatment (OR = 2.952, p = 0.001). CONCLUSION: Early termination of clinical trials investigating interventions for the treatment of GBM is associated with diagnostic trials relative to therapeutic trials. Patient accrual difficulties are the most commonly identified reason for early trial termination. Predictors of trial termination should be considered when designing GBM-related clinical trials to minimize the odds of early trial termination. Springer US 2022-06-01 2022 /pmc/articles/PMC9158304/ /pubmed/35648307 http://dx.doi.org/10.1007/s11060-022-04039-y Text en © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Review
Shah, Harshal A.
Mishra, Akash
Gouzoulis, Michael J.
Ben-Shalom, Netanel
D’Amico, Randy S.
Analysis of factors leading to early termination in glioblastoma-related clinical trials
title Analysis of factors leading to early termination in glioblastoma-related clinical trials
title_full Analysis of factors leading to early termination in glioblastoma-related clinical trials
title_fullStr Analysis of factors leading to early termination in glioblastoma-related clinical trials
title_full_unstemmed Analysis of factors leading to early termination in glioblastoma-related clinical trials
title_short Analysis of factors leading to early termination in glioblastoma-related clinical trials
title_sort analysis of factors leading to early termination in glioblastoma-related clinical trials
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9158304/
https://www.ncbi.nlm.nih.gov/pubmed/35648307
http://dx.doi.org/10.1007/s11060-022-04039-y
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