Advanced

Coronavirus Disease 2019 Related Clinical Studies : A Cross-Sectional Analysis

Ma, Lin Lu ; Yin, Xuan ; Li, Bing Hui ; Yang, Jia Yu ; Jin, Ying Hui ; Huang, Di ; Deng, Tong ; Wang, Yun Yun ; Ren, Xue Qun and Ji, Jianguang LU , et al. (2020) In Frontiers in Pharmacology 11.
Abstract

Objective: The quality and rationality of many recently registered clinical studies related to coronavirus disease 2019 (COVID-19) needs to be assessed. Hence, this study aims to evaluate the current status of COVID-19 related registered clinical trial. Methods: We did an electronic search of COVID-19 related clinical studies registered between December 1, 2019 and February 21, 2020 (updated to May 28, 2020) from the ClinicalTrials.gov, and collected registration information, study details, recruitment status, characteristics of the subjects, and relevant information about the trial implementation process. Results: A total of 1,706 studies were included 10.0% of which (n=171) were from France, 943 (55.3%) used an interventional design,... (More)

Objective: The quality and rationality of many recently registered clinical studies related to coronavirus disease 2019 (COVID-19) needs to be assessed. Hence, this study aims to evaluate the current status of COVID-19 related registered clinical trial. Methods: We did an electronic search of COVID-19 related clinical studies registered between December 1, 2019 and February 21, 2020 (updated to May 28, 2020) from the ClinicalTrials.gov, and collected registration information, study details, recruitment status, characteristics of the subjects, and relevant information about the trial implementation process. Results: A total of 1,706 studies were included 10.0% of which (n=171) were from France, 943 (55.3%) used an interventional design, and 600 (35.2%) used an observational design. Most of studies (73.6%) aimed to recruit fewer than 500 people. Interferon was the main prevention program, and antiviral drugs were the main treatment program. Hydroxychloroquine and chloroquine (230/943, 24.4%) were widely studied. Some registered clinical trials are incomplete in content, and 37.4% of the 1,706 studies may have had insufficient sample size. Conclusion: The quality of COVID-19 related studies needs to be improved by strengthening the registration process and improving the quality of clinical study protocols so that these clinical studies can provide high-quality clinical evidence related to COVID-19.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
clinical trial, ClinicalTrials.gov, coronavirus disease 2019, registration, SARS-CoV-2
in
Frontiers in Pharmacology
volume
11
article number
540187
publisher
Frontiers Media S. A.
external identifiers
  • pmid:32982751
  • scopus:85090950749
ISSN
1663-9812
DOI
10.3389/fphar.2020.540187
language
English
LU publication?
yes
id
956fb641-6cb3-4a22-9c82-6ef4a450054e
date added to LUP
2020-09-29 15:40:21
date last changed
2021-02-17 04:24:38
@article{956fb641-6cb3-4a22-9c82-6ef4a450054e,
  abstract     = {<p>Objective: The quality and rationality of many recently registered clinical studies related to coronavirus disease 2019 (COVID-19) needs to be assessed. Hence, this study aims to evaluate the current status of COVID-19 related registered clinical trial. Methods: We did an electronic search of COVID-19 related clinical studies registered between December 1, 2019 and February 21, 2020 (updated to May 28, 2020) from the ClinicalTrials.gov, and collected registration information, study details, recruitment status, characteristics of the subjects, and relevant information about the trial implementation process. Results: A total of 1,706 studies were included 10.0% of which (n=171) were from France, 943 (55.3%) used an interventional design, and 600 (35.2%) used an observational design. Most of studies (73.6%) aimed to recruit fewer than 500 people. Interferon was the main prevention program, and antiviral drugs were the main treatment program. Hydroxychloroquine and chloroquine (230/943, 24.4%) were widely studied. Some registered clinical trials are incomplete in content, and 37.4% of the 1,706 studies may have had insufficient sample size. Conclusion: The quality of COVID-19 related studies needs to be improved by strengthening the registration process and improving the quality of clinical study protocols so that these clinical studies can provide high-quality clinical evidence related to COVID-19.</p>},
  author       = {Ma, Lin Lu and Yin, Xuan and Li, Bing Hui and Yang, Jia Yu and Jin, Ying Hui and Huang, Di and Deng, Tong and Wang, Yun Yun and Ren, Xue Qun and Ji, Jianguang and Zeng, Xian Tao},
  issn         = {1663-9812},
  language     = {eng},
  publisher    = {Frontiers Media S. A.},
  series       = {Frontiers in Pharmacology},
  title        = {Coronavirus Disease 2019 Related Clinical Studies : A Cross-Sectional Analysis},
  url          = {http://dx.doi.org/10.3389/fphar.2020.540187},
  doi          = {10.3389/fphar.2020.540187},
  volume       = {11},
  year         = {2020},
}