Registration characteristics of global clinical trials of coronavirus disease 2019
10.3760/cma.j.cn311365-20210216-00055
- VernacularTitle:全球新型冠状病毒肺炎临床试验的注册特点
- Author:
Xifeng SHEN
1
;
Yuan YANG
;
Ran ZHANG
;
Huan YIN
;
Ling LI
;
Dongping GAO
Author Information
1. 中国医学科学院 北京协和医学院医学信息研究所 健康科技战略情报研究室 100020
- Keywords:
Coronavirus infections;
Clinical trial;
COVID-19;
Clinicial trials database
- From:
Chinese Journal of Infectious Diseases
2021;39(8):464-469
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To get comprehensive understanding of the registration characteristics of global clinical trials of coronavirus disease 2019(COVID-19) based on the ClinicalTrials. gov and the Chinese Clinical Trial Registry (ChiCTR).Methods:The clinical trials of COVID-19 in the ClinicalTrials.gov and ChiCTR were retrieved. The search start time was unlimited, with deadlines of 14 December, 2020 and 19 March, 2021, respectively. The registration numbers, registration submitted time, country/region distribution, recruitment status, study types, number of recruits, research phases, and other aspects were analyzed by using bibliometric methods.Results:As of March 19, 2021, there were 775 clinical trials in ChiCTR. As of December 14, 2020, there were 4 137 clinical trials in the ClinicalTrials.gov, and 3 157(76.31%) of the clinical trials recruited subjects who were aged≥18 years old. There were 2 347 intervention trials and 1 759 observational trials. The intervention measures mainly included drugs, biologics and medical devices. The numbers of recruits were 110(48, 308) cases for interventional studies, and 300(100, 1 000) cases for observational trials. The interventional research phases were mainly phaseⅡ (570 items) and phase Ⅲ (358 items). Totally, 50.33%(2 082/4 137) of the clinical trials were under recruitment, 13.10%(542/4 137) had been completed. Among the interventional studies, 729(31.06%) were multi-center studies, with the center numbers of 5(2, 15).Conclusions:At present, there are a large number of clinical trials with various intervention measures in the world. However, the number of recruits is unreasonable, and multi-center study with multi-agency cooperation is insufficient.
