Analysis of registration data for clinical trials of pneumoconiosis
10.3760/cma.j.issn.1001-9391.2020.01.004
- VernacularTitle: 尘肺病临床试验的注册数据分析
- Author:
Hulei ZHAO
1
,
2
;
Yang XIE
3
;
Jiansheng LI
1
,
2
Author Information
1. Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
2. Henan University of Chinese Medicine, Zhengzhou 450046, China
3. The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China
- Publication Type:Case Reports
- Keywords:
Pneumoconiosis;
Clinical trial;
International clinical trials registry;
Research
- From:
Chinese Journal of Industrial Hygiene and Occupational Diseases
2020;38(1):20-23
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the registration characteristics and development trend of clinical trials of pneumoconiosis, analyze the clinical research characteristics and current situation of prevention and treatment pneumoconiosis.
Methods:In December 2018, the databases of primary registries certified by International Clinical Trials Registry Platform (ICTRP) , such as Chinese Clinical Trial Registry (ChiCTR) , Clinical Trials. gov, and Japan Primary Registries Network (JPRN) were retrieved. All clinical trials related to pneumoconiosis were included from the database establishment until December 1, 2018, and the characteristics of registered clinical trials were analyzed.
Results:A total of 23 clinical trials related to pneumoconiosis were inclued. The number of registrations in China and Brazil are 9 and 3 respectively, while the registration numbers of Clinical Trials. gov and ChiCTR are 10 and 5 respectively. Fourteen trials have been completed; five trials are ongoing, and four trials are unknown for the research progress. Ten trials were for silicosis patients. Eight trials with a sample size less than 50. Twelve trials were randomized controlled trials. Interventions of five clinical trial are pulmonary rehabilitation. There were six trials with a 12-month course of treatment.
Conclusion:At present, the number of registered studies in clinical trials of pneumoconiosis is relatively less; the proportion of published clinical research results is low, and some clinical research status is unknown. It should increase the publicity of the registration of clinical trials for pneumoconiosis, improve the awareness of registration and the intensity of research design to promote the development of high-quality clinical trials.
