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Review
. 2022 Jul;158(3):489-495.
doi: 10.1007/s11060-022-04039-y. Epub 2022 Jun 1.

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

Harshal A Shah  1 , Akash Mishra  2 , Michael J Gouzoulis  3 , Netanel Ben-Shalom  4 , Randy S D'Amico  4
Affiliations
Review

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

Harshal A Shah et al. J Neurooncol. 2022 Jul.

Abstract

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.

Keywords: Clinical trial termination; Clinical trials; Glioblastoma; Glioblastoma trials; Glioma.

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Conflict of interest statement

The authors have no relevant competing interests to disclose.

Figures

Fig. 1
Fig. 1
Forest plot demonstrating results of multinomial logistic regression for terminated GBM-related clinical trials. “Other” funding sources include academic institutions such as universities, hospitals, individuals, or community-based organizations. Reference values for primary intervention, phase, funding source, interventional model, and primary purpose were drug, phase I, industry, parallel assignment, and treatment, respectively. OR odds ratio, CI confidence interval, NIH National Institutes of Health, Ref reference
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