Background

Increasing neurological disease burden and advancing treatment options require clinical trials to expand the evidence base of clinical care. We aimed to characterize neurology clinical trials registered between October 2007 and April 2018 and identify features associated with early discontinuation and results reporting.

Methods

We compared 16,994 neurology (9.4%) and 163,714 non-neurology comparison trials registered to ClinicalTrials.gov. Trials therapeutic focus within neurology was assigned via combination programmatic and manual review. We performed descriptive analyses of trial characteristics, cox regression of early discontinuation, and multivariable logistic regression for results reporting within 3 years of completion.

Results

Most neurology trials were academic-funded (58.5%) followed by industry (31.9%) and US-government (9.6%). Neurology trials focused more on treatment than prevention compared to non-neurology studies. Of neurology trials, 11.3% discontinued early, and 32.2% of completed trials reported results by April 30, 2018. In multivariable analysis accounting for time-to-event, neurology trials were at lower risk of discontinuation than non-neurology trials (adjusted hazard 0.83, p < 0.0001). Both academic and government-funded trials had greater risk of discontinuation than industry (adjusted hazard 0.57 and 0.46, respectively). Among completed trials, government-funded studies (adjusted odds ratio 2.12, p < 0.0001) had highest odds of results reporting while academic trials reported less (adjusted odds ratio 0.51, p < 0.0001).

Conclusions

Funding source is associated with trial characteristics and outcomes in neurology. Improvements in trial completion and timely dissemination of results remain urgent goals for the field.

中文翻译：

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2007 年至 2018 年在 ClinicalTrials.gov 上的神经病学试验注册：特征、提前终止和结果报告的横断面分析

背景

增加神经系统疾病负担和推进治疗选择需要临床试验来扩大临床护理的证据基础。我们旨在表征 2007 年 10 月至 2018 年 4 月期间注册的神经病学临床试验，并确定与提前停药和结果报告相关的特征。

方法

我们比较了在 ClinicalTrials.gov 注册的 16,994 项神经病学 (9.4%) 和 163,714 项非神经病学比较试验。神经病学内的试验治疗重点通过程序化和人工审查相结合进行分配。我们对试验特征、早期停药的 cox 回归和完成后 3 年内结果报告的多变量逻辑回归进行了描述性分析。

结果

大多数神经病学试验由学术资助 (58.5%)，其次是工业 (31.9%) 和美国政府 (9.6%)。与非神经病学研究相比，神经病学试验更侧重于治疗而非预防。在神经病学试验中，11.3% 提前终止，32.2% 的已完成试验在 2018 年 4 月 30 日之前报告结果。在考虑到事件发生时间的多变量分析中，神经病学试验的终止风险低于非神经病学试验（调整风险0.83, p < 0.0001)。学术界和政府资助的试验都比工业界有更大的终止风险（调整后的风险分别为 0.57 和 0.46）。在已完成的试验中，政府资助的研究（调整后的优势比 2.12，p < 0.0001）报告结果的几率最高，而学术试验报告的结果较少（调整后的优势比 0.51，p < 0.0001）。

结论

资金来源与神经病学的试验特征和结果相关。改善试验完成和及时传播结果仍然是该领域的紧迫目标。