AUTHOR=Guo Ruili , Yang Qingya , Zhou Xuan , Li Shining , Liu Yao 

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

JOURNAL=Frontiers in Medicine

VOLUME=11

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1435762

DOI=10.3389/fmed.2024.1435762

ISSN=2296-858X

ABSTRACT=<sec id="sec1"><title>Objective</title><p>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.</p></sec><sec id="sec2"><title>Methods</title><p>We collected information on clinical trials related to traumatic brain injury (TBI) from the <ext-link xlink:href="https://ClinicalTrials.gov" ext-link-type="uri" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link> database, identified key categorical variables, and assessed their characteristics.</p></sec><sec id="sec3"><title>Results</title><p>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%, <italic>p</italic> &lt; 0.001). In addition, between 2014 and 2023, there was an increase in trials for diagnostic purposes (2.4% vs. 6.5%, <italic>p</italic> &lt; 0.001).</p></sec><sec id="sec4"><title>Conclusion</title><p>Based on the data collected from the <uri xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</uri>, 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.</p></sec>