Analysis of the discontinuation and nonpublication of neurooncological randomized clinical trials.

IF 3.7 Q1 CLINICAL NEUROLOGY Neuro-oncology advances Pub Date : 2024-08-01 eCollection Date: 2024-01-01 DOI:10.1093/noajnl/vdae136
Molly Butler, Mehul Mehra, Abdullah Chandasir, Lydia Kaoutzani, Fernando L Vale
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Abstract

Background: Premature discontinuation and nonpublication of clinical trials contribute to research waste and compromise our ability to improve patient outcomes. However, the extent to which these problems exist in neurooncological randomized clinical trials (RCTs) is not known. This study aimed to evaluate the prevalence of discontinuation and nonpublication of neurooncological RCTs, identify contributing factors, and assess trial characteristics associated with each.

Methods: We performed a retrospective, cross-sectional study of neurooncological RCTs registered in Clinicaltrials.gov before March 7, 2023. Data were collected from Clinicaltrials.gov and associated publications were located. We attempted to contact authors for all trials without associated publications or an identified reason for discontinuation.

Results: Of 139 included RCTs, 57 (41%) were discontinued. The most common reason for discontinuation identified was slow enrollment or accrual (23%), though 30 trials (53%) were discontinued for unknown reasons. Trials funded by sources other than industry or the National Institutes of Health were more likely to be discontinued (odds ratio 4.2, 95% confidence interval 1.3-13.8). In total, 67 of the 139 (48%) RCTs were unpublished, including 50 of the 57 (88%) discontinued studies and 17 of the 82 (21%) completed studies.

Conclusions: In our study, discontinuation of neurooncological clinical trials was common and often occurred for unknown reasons. Trials were also frequently unpublished, particularly those that were discontinued. Addressing these findings may provide an opportunity to reduce research waste and improve outcomes for patients with neurological cancers.

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神经肿瘤随机临床试验的终止和未公开分析。
背景:临床试验的过早终止和未公开造成了研究浪费,损害了我们改善患者预后的能力。然而,这些问题在神经肿瘤随机临床试验(RCT)中的存在程度尚不清楚。本研究旨在评估神经肿瘤学 RCT 中止和未公开的普遍程度,找出诱因并评估与之相关的试验特征:我们对2023年3月7日前在Clinicaltrials.gov上注册的神经肿瘤RCT进行了一项回顾性横断面研究。我们从 Clinicaltrials.gov 收集了数据,并找到了相关出版物。我们试图联系所有未发表相关出版物或未确定中止原因的试验的作者:在 139 项纳入的 RCT 中,有 57 项(41%)被终止。最常见的终止原因是入组或累积缓慢(23%),但也有 30 项试验(53%)因不明原因而终止。由工业界或美国国立卫生研究院以外的其他机构资助的试验更有可能被终止(几率比4.2,95%置信区间1.3-13.8)。在139项RCT中,共有67项(48%)未发表,包括57项中止研究中的50项(88%)和82项完成研究中的17项(21%):结论:在我们的研究中,神经肿瘤临床试验终止的情况很普遍,而且往往原因不明。我们的研究结果表明:在我们的研究中,中止神经肿瘤临床试验的情况非常普遍,而且往往原因不明。解决这些问题可以减少研究浪费,改善神经系统癌症患者的治疗效果。
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来源期刊
CiteScore
6.20
自引率
0.00%
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0
审稿时长
12 weeks
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