Rates of Discontinuation and Nonpublication of Ischemic Stroke Trials Involving Intravenous Thrombolysis: A Cross-sectional Analysis
Maha AbuZarifa1, Asmaa Alnajjar2, Omar Abdelsalam3, Khaled M.H Mohamed4, Mohammed B AbuZarifa5
1Al-Quds University, Al-Azhar Branch, Gaza, Palestine, 2Faculty of Medicine Al-Azhar University, Gaza, Palestine, 3Faculty of Medicine, New Mansoura University, New Mansoura, Egypt, 4Visiting scholar, Pharmaceutical Sciences Department, College of Health and Human Sciences, North Dakota State University, Fargo, ND, USA, 5Faculty of Medicine, Ain Shams University, Cairo, Egypt
Objective:
To systematically investigate the rates of discontinuation and non-publication of interventional clinical trials related to IVT as a therapy for ischemic stroke.
Background:
Intravenous thrombolysis(IVT) is an effective therapy for ischemic stroke, with current guidelines establishing it as the cornerstone of acute ischemic stroke treatment. Interventional clinical trials play a critical role in informing clinical decision-making. However, discontinuation and non-publication of these trials undermine scientific progress and may bias the medical evidence base.
Design/Methods:
We systematically searched ClinicalTrials.gov for all registered studies involving ischemic stroke patients treated with IVT from inception to June 18, 2023. Publications were identified via NCT identifiers, ClinicalTrials.gov references, or manually. Multivariate logistic regression was performed to determine associations between trial characteristics and both completion status and publication status.
Results:
In the analysis of the 101 trials, we found 65(64.40%) trials were published and 36 (35.60%) were unpublished. Of 35 discontinued trials, 10 (28.57%) reached publication. In addition, of 66 completed trials, 54(81.82%) were published. A total of 550592 study participants were recruited in the 101 included trials. Of them, 52537 participants (9.54%) do not publish. The most commonly listed reason for discontinuation was operational challenges 7, (70.00%). The multivariate logistic regression showed that enrollment size is a significant predictor of trial discontinuation and publication.
Conclusions:
Improving the trial design, enrollment size, and reporting practices is essential to advance ischemic stroke trials involving intravenous thrombolysis research and ensure broader accessibility to clinical findings.
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