Reporting and design of randomized controlled trials for COVID-19: A systematic review.
Contemp Clin Trials
; 101: 106239, 2021 02.
Article
in English
| MEDLINE | ID: covidwho-956961
ABSTRACT
BACKGROUND:
The novel coronavirus 2019 (COVID-19) pandemic has mobilized global research at an unprecedented scale. While challenges associated with the COVID-19 trial landscape have been discussed previously, no comprehensive reviews have been conducted to assess the reporting, design, and data sharing practices of randomized controlled trials (RCTs).PURPOSE:
The purpose of this review was to gain insight into the current landscape of reporting, methodological design, and data sharing practices for COVID-19 RCTs. DATA SOURCES We conducted three searches to identify registered clinical trials, peer-reviewed publications, and pre-print publications. STUDY SELECTION After screening eight major trial registries and 7844 records, we identified 178 registered trials and 38 publications describing 35 trials, including 25 peer-reviewed publications and 13 pre-prints. DATA EXTRACTION Trial ID, registry, location, population, intervention, control, study design, recruitment target, actual recruitment, outcomes, data sharing statement, and time of data sharing were extracted. DATASYNTHESIS:
Of 178 registered trials, 112 (62.92%) were in hospital settings, median planned recruitment was 100 participants (IQR 60, 168), and the majority (n = 166, 93.26%) did not report results in their respective registries. Of 35 published trials, 31 (88.57%) were in hospital settings, median actual recruitment was 86 participants (IQR 55.5, 218), 10 (28.57%) did not reach recruitment targets, and 27 trials (77.14%) reported plans to share data.CONCLUSIONS:
The findings of our study highlight limitations in the design and reporting practices of COVID-19 RCTs and provide guidance towards more efficient reporting of trial results, greater diversity in patient settings, and more robust data sharing.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Randomized Controlled Trials as Topic
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Qualitative research
/
Randomized controlled trials
/
Reviews
/
Systematic review/Meta Analysis
Limits:
Humans
Language:
English
Journal:
Contemp Clin Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2021
Document Type:
Article
Affiliation country:
J.cct.2020.106239
Similar
MEDLINE
...
LILACS
LIS