Bibliometric analysis of registration of thyroid-associated ophthalmopathy clinical trials based on ICTRP
10.3760/cma.j.cn115989-20240720-00200
- VernacularTitle:基于ICTRP平台的甲状腺相关眼病临床试验注册的计量学分析
- Author:
Shuyi LIU
1
;
Jiacheng YAN
1
;
Hang LI
1
;
Wei LU
1
Author Information
1. 大连医科大学附属第二医院眼科，大连 116000
- Publication Type:Journal Article
- Keywords:
Thyroid-associated ophthalmopathy;
Clinical trials;
Registration;
Monoclonal antibody drugs
- From:
Chinese Journal of Experimental Ophthalmology
2025;43(9):833-838
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the characteristics of thyroid-associated ophthalmopathy (TAO) clinical trials based on WHO International Clinical Trials Registry Platform (ICTRP).Methods:The WHO ICTRP database was searched from their inception to October 25, 2024.Data including the basic registration information, study type, study design, study stage, intervention measures and outcomes were extracted, and a descriptive analysis of the included trials was performed using bibliometric method.Results:A total of 288 trials were identified, the number of registrations for TAO interventional clinical trials was on the rise.Among them, 13 trials without key registration information, 93 without intervention, 2 with non-TAO subjects, 28 without control group, and 4 with duplicate study registration numbers or extension studies were excluded.Finally, 142 intervention trials were included in this study.The top three in registration numbers were China (44 trials), the United States (40 trials), and Europe (31 trials), and most of them were single-center studies (99 trials, accounting for 69.7%). For study design, 131 trials were randomized controlled trials, and 122 trials reported its masking method.Main stage of the trials was phase Ⅲ (31 trials, accounting for 21.8%). Drug treatments (121 trials, accounting for 85.2%) were the main intervention measures, and most of them were monoclonal antibody drugs (55 trials). Clinical activity score (81 trials) and exophthalmia (80 trials) were the commonly used outcome measures.Conclusions:The number of registrations for TAO interventional clinical trials is on the rise, with monoclonal antibody drugs as the main intervention measures.However, issues such as the limited registration number, uneven distribution of countries/regions, incomplete information, and low quality of study design remain to be addressed.Researchers should raise the awareness of registration and design of clinical trials, deepen international and interregional cooperation, improve the review and tracking mechanism of clinical trial registration platforms, and promote the high-quality development of TAO clinical trials.
