Analysis and consideration of registration information of global coronavirus disease 2019 clinical study
10.3969/j.issn.1674-8115.2020.06.002
- VernacularTitle: 全球新型冠状病毒肺炎临床研究注册信息的分析与思考
- Author:
Tian-Tian QU
1
Author Information
1. Hongqiao International Institute of Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine
- Publication Type:Journal Article
- Keywords:
Clinical study registration;
Registration characteristics;
SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2);
Study design
- From:
Journal of Shanghai Jiaotong University(Medical Science)
2020;40(6):707-712
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To analyze the registration characteristics of registered clinical research, and find the potential scientific and feasibility problems of clinical research on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), providing reference for the good management of follow-up research registration. Methods: The key words of coronavirus disease 2019 (COVID-19) were identified and retrieved from Chinese Clinical Trial Registry and ClinicalTrials website. The registration characteristics of ethical status, number of recruits, total time, number of groups, intervention, study endpoint type, withdrawal, randomized controlled trial (RCT), stage, registration type, provinces distribution and patients' condition were summarized. IBM SPSS 22.0 software was used to analyze the above characteristics. Results: A total of 400 registered clinical studies were collected. Among them, 59 studies were not ethically approved, 15 studies were withdrawn, and stages of 303 studies were unclear. The differences of the three registration characteristics on the two official websites were statistically significant (all P<0.05). Fourteen studies recruited more than 1 000 people, the total time of 189 studies exceeded 6 months, and the number of groups in 22 studies exceeded 4 groups. There was no significant difference in the three registration characteristics on the two official websites. Only 15 studies were industry-sponsored trial. Most registered clinical studies were distributed in Hubei Province. Conclusion: The awareness of Chinese investigator initiating trial registration has increased. However, by collating and analyzing the registration information, it is found that the study design is not rigorous, so it is necessary to strengthen the registration quality management and study design methodological demonstration.
