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SYSTEMATIC REVIEW article

Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1435762
This article is part of the Research Topic The Integrity of Randomized Clinical Trials View all 3 articles

Characteristic of clinical trials related to traumatic brain injury registered on ClinicalTrials.gov over the past two decades(2004-2023)

Provisionally accepted
Ruili Guo Ruili Guo *Qingya Yang Qingya Yang Xuan Zhou Xuan Zhou Shining Li Shining Li Yao Liu Yao Liu
  • Ningbo First Hospital, Ningbo, Zhejiang Province, China

The final, formatted version of the article will be published soon.

    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%, P<0.001). In addition, between 2014 and 2023, there was an increase in trials for diagnostic purposes (2.4% vs. 6.5%, P<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.

    Keywords: Traumatic Brain Injury, Clinical Trial, Clinicaltrials.gov, Study Design, Early discontinuation, therapy category

    Received: 22 May 2024; Accepted: 03 Sep 2024.

    Copyright: © 2024 Guo, Yang, Zhou, Li and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Ruili Guo, Ningbo First Hospital, Ningbo, 315016, Zhejiang Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.