Study Design: 

Cross-sectional analysis of completed and terminated spine-related clinical trials in the ClinicalTrials.gov registry.

Objective: 

The aim was to quantify completed and terminated spine-related clinical trials, assess reasons for termination, and determine predictors of termination by comparing characteristics of completed and terminated trials.

Summary of Background Data: 

Clinical trials are key to the advancement of products and procedures related to the spine. Unfortunately, trials may be terminated before completion. ClinicalTrials.gov is a registry and results database maintained by the National Library of Medicine that catalogs trial characteristics and tracks overall recruitment status (eg, ongoing, completed, terminated) for each study as well as reasons for termination. Reasons for trial termination have not been specifically evaluated for spine-related clinical trials.

Methods: 

The ClinicalTrials.gov database was queried on July 20, 2021 for all completed and terminated interventional studies registered to date using all available spine-related search terms. Trial characteristics and reason for termination, were abstracted. Univariate and multivariate analyses were performed determine predictors of trial termination.

Results: 

A total of 969 clinical trials were identified and characterized (833 completed, 136 terminated). Insufficient rate of participant accrual was the most frequently reported reason for trial termination, accounting for 33.8% of terminated trials.

Multivariate analysis demonstrated increased odds of trial termination for industry-sponsorship [odds ratio (OR)=1.59] relative to sponsorship from local groups, device studies (OR=2.18) relative to investigations of drug or biological product(s), and phase II (OR=3.07) relative to phase III studies (P<0.05 for each).

Conclusions: 

Spine-related clinical trials were found to be terminated 14% of the time, with insufficient accrual being the most common reason for termination. With significant resources put into clinical studies and the need to advance scientific objectives, predictors, and reasons for trial termination should be considered and optimized to increase the completion rate of trials that are initiated.

中文翻译：

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脊柱相关临床试验的频率、特点及终止原因分析

学习规划： 

对 ClinicalTrials.gov 登记处已完成和终止的脊柱相关临床试验的横断面分析。

客观的： 

目的是量化已完成和终止的脊柱相关临床试验，评估终止原因，并通过比较已完成和终止试验的特征来确定终止的预测因素。

背景数据摘要： 

临床试验是脊柱相关产品和手术进步的关键。不幸的是，试验可能会在完成之前终止。ClinicalTrials.gov 是由国家医学图书馆维护的注册和结果数据库，对试验特征进行分类并跟踪每项研究的总体招募状态（例如，正在进行、已完成、终止）以及终止原因。尚未针对脊柱相关临床试验专门评估试验终止的原因。

方法： 

2021 年 7 月 20 日，使用所有可用的脊柱相关搜索词对 ClinicalTrials.gov 数据库进行了查询，了解迄今为止注册的所有已完成和终止的介入研究。试验特征和终止原因被抽象化。进行单变量和多变量分析以确定试验终止的预测因素。

结果： 

总共确定并描述了969 项临床试验（833 项已完成，136 项已终止）。受试者应计率不足是试验终止最常见的原因，占终止试验的 33.8%。

多变量分析表明，相对于当地团体的赞助、相对于药物或生物制品的调查和 II 期研究的器械研究 (OR=2.18)，行业赞助的试验终止几率增加 [优势比 (OR)=1.59] (OR=3.07) 相对于 III 期研究（每项P <0.05）。

结论： 

脊柱相关临床试验有 14% 被终止，其中最常见的终止原因是应计费用不足。随着临床研究投入大量资源以及推进科学目标的需要，应考虑和优化试验终止的预测因素和原因，以提高已启动试验的完成率。