Guo Ruili, Yang Qingya, Zhou Xuan, Li Shining, Liu Yao
The First Affiliated Hospital of Ningbo University, Ningbo, China.
Front Med (Lausanne). 2024 Sep 16;11:1435762. doi: 10.3389/fmed.2024.1435762. eCollection 2024.
The aim of this report is to provide a comprehensive overview of clinical trials and protocols related to traumatic brain injury over the past two decades.
We collected information on clinical trials related to traumatic brain injury (TBI) from the ClinicalTrials.gov database, identified key categorical variables, and assessed their characteristics.
A total of 367 TBI-related trials were identified for analysis. All identified trials were interventional clinical trials. Most trials were small-scale, with 75.2% enrolling 1-100 participants, and only about 20% were funded by industry or the National Institutes of Health (NIH). In most trials, participants were gender-neutral (96.5%), and the primary age group was adults and older adults (56.9%). Of all identified TBI trials, 78.2% were randomized, and 69.4% were blinded. Additionally, the primary purpose of 297 trials (80.9%) was treatment, with drug therapy as the most common intervention. A total of 153 trials (41.7%) were completed; however, only 58 trials submitted results to the registry. Furthermore, 81 trials (22.1%) were discontinued early, primarily due to recruitment problems. Clinical trials started between 2004 and 2013 reported a higher proportion of results compared with those started between 2014 and 2023 (35.1% vs. 11.1%, < 0.001). In addition, between 2014 and 2023, there was an increase in trials for diagnostic purposes (2.4% vs. 6.5%, < 0.001).
Based on the data collected from the ClinicalTrials.gov, our study reveals that most clinical trials related to TBI focus on drug-related treatments, underreporting remains a significant concern, and greater emphasis should be placed on improving the publication and dissemination of clinical trial results.
本报告旨在全面概述过去二十年中与创伤性脑损伤相关的临床试验和方案。
我们从ClinicalTrials.gov数据库收集了与创伤性脑损伤（TBI）相关的临床试验信息，确定了关键分类变量，并评估了它们的特征。
共确定367项与TBI相关的试验进行分析。所有确定的试验均为干预性临床试验。大多数试验规模较小，75.2%的试验招募1至100名参与者，只有约20%由行业或美国国立卫生研究院（NIH）资助。在大多数试验中，参与者无性别差异（96.5%），主要年龄组为成年人及老年人（56.9%）。在所有确定的TBI试验中，78.2%为随机试验，69.4%为盲法试验。此外，297项试验（80.9%）的主要目的是治疗，药物治疗是最常见的干预措施。共有153项试验（41.7%）完成；然而，只有58项试验向登记处提交了结果。此外，81项试验（22.1%）提前终止，主要原因是招募问题。与2014年至2023年启动的试验相比，2004年至2013年启动的临床试验报告结果的比例更高（35.1%对11.1%，<0.001）。此外，2014年至2023年期间，诊断性试验有所增加（从2.4%增至6.5%，<0.001）。
基于从ClinicalTrials.gov收集的数据，我们的研究表明，大多数与TBI相关的临床试验侧重于药物相关治疗，报告不足仍然是一个重大问题，应更加重视改善临床试验结果的发表和传播。
