Clinical trials in COVID-19 management & prevention: A meta-epidemiological study examining methodological quality.
J Clin Epidemiol
; 139: 68-79, 2021 11.
Article
in English
| MEDLINE | ID: covidwho-1466592
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
ABSTRACT
OBJECTIVE:
To describe the characteristics of Covid-19 randomized clinical trials (RCTs) and examine the association between trial characteristics and the likelihood of finding a significant effect. STUDYDESIGN:
We conducted a systematic review to identify RCTs (up to October 21, 2020) evaluating drugs or blood products to treat or prevent Covid-19. We extracted trial characteristics (number of centers, funding sources, and sample size) and assessed risk of bias (RoB) using the Cochrane RoB 2.0 tool. We performed logistic regressions to evaluate the association between RoB due to randomization, single vs. multicentre, funding source, and sample size, and finding a statistically significant effect.RESULTS:
We included 91 RCTs (n = 46,802); 40 (44%) were single-center, 23 (25.3%) enrolled <50 patients, 28 (30.8%) received industry funding, and 75 (82.4%) had high or probably high RoB. Thirty-eight trials (41.8%) reported a statistically significant effect. RoB due to randomization and being a single-center trial were associated with increased odds of finding a statistically significant effect.CONCLUSIONS:
There is high variability in RoB among Covid-19 trials. Researchers, funders, and knowledge-users should be cognizant of the impact of RoB due to randomization and single-center trial status in designing, evaluating, and interpreting the results of RCTs. REGISTRATION CRD42020192095.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Research Design
/
Randomized Controlled Trials as Topic
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
/
Reviews
/
Systematic review/Meta Analysis
Limits:
Humans
Language:
English
Journal:
J Clin Epidemiol
Journal subject:
Epidemiology
Year:
2021
Document Type:
Article
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