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

Clinical trial termination Clinical trials Glioblastoma Glioblastoma trials Glioma

Journal

Journal of neuro-oncology
ISSN: 1573-7373
Titre abrégé: J Neurooncol
Pays: United States
ID NLM: 8309335

Informations de publication

Date de publication:
Jul 2022
Historique:
received: 13 04 2022
accepted: 17 05 2022
pubmed: 2 6 2022
medline: 7 7 2022
entrez: 1 6 2022
Statut: ppublish

Résumé

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. 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. 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). 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.

Identifiants

pubmed: 35648307
doi: 10.1007/s11060-022-04039-y
pii: 10.1007/s11060-022-04039-y
pmc: PMC9158304
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

489-495

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

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Auteurs

Harshal A Shah (HA)

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, 500 Hofstra Blvd Hempstead, New York, NY, 11549, USA. hshah5@northwell.edu.

Akash Mishra (A)

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, 500 Hofstra Blvd Hempstead, New York, NY, 11549, USA.

Michael J Gouzoulis (MJ)

Yale University School of Medicine, New Haven, CT, USA.

Netanel Ben-Shalom (N)

Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra, New York, NY, USA.

Randy S D'Amico (RS)

Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra, New York, NY, USA.

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Classifications MeSH