Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Department of Endocrinology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Front Endocrinol (Lausanne). 2020 Nov 20;11:575799. doi: 10.3389/fendo.2020.575799. eCollection 2020.
A better understanding of the current characteristics of clinical trials on thyroid cancer (TC) is important to improve trial designs and identify neglected areas of research. However, there is a lack of a thorough understanding of the clinical studies on TC. Therefore, this study aimed to present a comprehensive overview of clinical trials on TC based on the ClinicalTrials.gov database and evaluate their publication status.
We searched for TC-related clinical studies registered in the ClinicalTrials.gov database before December 2018 by using the keyword "thyroid cancer" and assessed the characteristics of the included trials. We searched the publication status of primary completed studies in PubMed and Google Scholar.
A total of 450 studies were identified for analysis, including 333 (74.0%) interventional studies and 117 (26.0%) observational studies. Interventional studies about TC were commonly non-randomized (67.6%), single-arm (55.6%), single-center (76.3%), and early-phase (60.0%) trials. The major category for which studies were performed was for target drug-related therapy (53.6%). In addition, 57.0% of the primary completed interventional studies were published. The published studies were more commonly primary completed studies after 2010 and used randomization and were less commonly designed as single-arm studies and were conducted in the USA/Canada, compared to non-published studies ( < 0.05 for all). The median time from primary completion to publication was 46.5 months, and the time decreased to 36.5 months after 2010. Studies conducted in the USA/Canada [odds ratio (OR) = 9.43, = 0.020] and multi-center studies (OR = 6.55, = 0.021) significantly increased the potential of publication in high-impact journals.
High-quality, randomized phase 3 trials regarding TC are still insufficient. Therefore, more efforts are needed to improve the treatment of poor prognostic TC and timely publication.
更好地了解甲状腺癌 (TC) 临床试验的当前特征对于改进试验设计和确定研究的忽视领域很重要。然而,人们对 TC 的临床研究缺乏全面的了解。因此,本研究旨在根据 ClinicalTrials.gov 数据库介绍 TC 临床试验的综合概述,并评估其发表状况。
我们使用关键字“甲状腺癌”在 ClinicalTrials.gov 数据库中搜索了 2018 年 12 月前注册的 TC 相关临床研究,并评估了纳入研究的特征。我们在 PubMed 和 Google Scholar 中搜索了主要完成研究的发表状况。
共确定了 450 项研究进行分析,其中 333 项(74.0%)为干预性研究,117 项(26.0%)为观察性研究。TC 的干预性研究通常为非随机(67.6%)、单臂(55.6%)、单中心(76.3%)和早期阶段(60.0%)试验。进行研究的主要类别是针对靶药物相关治疗(53.6%)。此外,57.0%的主要完成干预性研究已发表。已发表的研究更常见于 2010 年后完成的主要研究,且使用了随机化,不太常见的是单臂研究,且更多地在美国/加拿大进行(所有 P<0.05)。从主要完成到发表的中位时间为 46.5 个月,2010 年后这一时间缩短至 36.5 个月。在美国/加拿大进行的研究[比值比(OR)=9.43,=0.020]和多中心研究(OR=6.55,=0.021)显著增加了在高影响力期刊上发表的可能性。
TC 的高质量、随机 3 期试验仍然不足。因此,需要做出更多努力来改善预后不良的 TC 的治疗效果并及时发表。