Reporting and design of randomized controlled trials for COVID-19 : A systematic review
Copyright © 2020 Elsevier Inc. All rights reserved..
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.
DATA SYNTHESIS: 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:101 |
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| Enthalten in: |
Contemporary clinical trials - 101(2021) vom: 26. Feb., Seite 106239 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dillman, Alison [VerfasserIn] |
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| Links: |
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| Themen: |
Coronavirus |
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| Anmerkungen: |
Date Completed 22.03.2021 Date Revised 28.03.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cct.2020.106239 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM318455927 |
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| 520 | |a Copyright © 2020 Elsevier Inc. All rights reserved. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a DATA SOURCES: We conducted three searches to identify registered clinical trials, peer-reviewed publications, and pre-print publications | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a DATA SYNTHESIS: 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Systematic Review | |
| 650 | 4 | |a Coronavirus | |
| 650 | 4 | |a Novel coronavirus 2019 | |
| 650 | 4 | |a Randomized controlled trials | |
| 650 | 4 | |a Systematic literature review | |
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| 700 | 1 | |a Mills, Edward J |e verfasserin |4 aut | |
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