TY - JOUR
T1 - Reporting and data sharing level for COVID-19 vaccine trials
T2 - A cross-sectional study
AU - Duan, Yuting
AU - Luo, Jingyuan
AU - Zhao, Lingyun
AU - Zhang, Xuan
AU - Miao, Jiangxia
AU - Moher, David
AU - Bian, Zhaoxiang
N1 - Funding Information:
This work was supported by the National Key R&D Program of China (2019YFC1710400; 2019YFC1710403). None of the sponsors had a role in any aspect of this study, including design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, approval of the manuscript, or decision to publish.
We thank the funding support from the National Key R&D Program of China (2019YFC1710400; 2019YFC1710403). We also thank Dr. Martha Dahlen for her critical English editing of the manuscript.
Publisher Copyright:
© 2022 The Authors. Published by Elsevier B.V.
PY - 2022/4
Y1 - 2022/4
N2 - Background: The results and data availability of vaccine trials directly affect the decisions of healthcare providers, the public, and policymakers as to whether the vaccine should be applied. However, the reporting and data sharing level of COVID-19 vaccine studies are not clear. Methods: A cross-sectional study was conducted. A systematic search up to 9 May 2021 in 12 databases and an updated search to 6 July 2021 were conducted in the Cochrane Living Systematic Review and Network Meta-Analysis database to identify COVID-19 vaccine trials. The basic characteristics of included trials were summarized. The reporting level was assessed according to the CONSORT checklist. The data sharing level was assessed by open science practices. Types of incomplete reporting including protocol deviation, lack of primary outcomes clarity, and the omission of harms were analyzed. Findings: Finally, thirty-six COVID-19 vaccine articles reporting on 40 randomized controlled trials were included in this analysis. Based on the CONSORT checklist, the mean reporting score was 29.7 [95% confidence interval 28.7, 30.7]. Thirty-one articles (31/36, 86.1%) had data sharing statements, twenty-five articles (25/36, 69.4%) provided access to the source data. Twenty-seven articles (27/36, 75.0%) had protocol deviation, lack of primary outcomes clarity, or the omission of harms. Interpretation: The reporting and data sharing level of COVID-19 vaccine trials were not optimal. We hope that the reporting and data sharing of future trials will be improved. We recommend establishing a comprehensive, accurate data sharing system for future vaccine trials.
AB - Background: The results and data availability of vaccine trials directly affect the decisions of healthcare providers, the public, and policymakers as to whether the vaccine should be applied. However, the reporting and data sharing level of COVID-19 vaccine studies are not clear. Methods: A cross-sectional study was conducted. A systematic search up to 9 May 2021 in 12 databases and an updated search to 6 July 2021 were conducted in the Cochrane Living Systematic Review and Network Meta-Analysis database to identify COVID-19 vaccine trials. The basic characteristics of included trials were summarized. The reporting level was assessed according to the CONSORT checklist. The data sharing level was assessed by open science practices. Types of incomplete reporting including protocol deviation, lack of primary outcomes clarity, and the omission of harms were analyzed. Findings: Finally, thirty-six COVID-19 vaccine articles reporting on 40 randomized controlled trials were included in this analysis. Based on the CONSORT checklist, the mean reporting score was 29.7 [95% confidence interval 28.7, 30.7]. Thirty-one articles (31/36, 86.1%) had data sharing statements, twenty-five articles (25/36, 69.4%) provided access to the source data. Twenty-seven articles (27/36, 75.0%) had protocol deviation, lack of primary outcomes clarity, or the omission of harms. Interpretation: The reporting and data sharing level of COVID-19 vaccine trials were not optimal. We hope that the reporting and data sharing of future trials will be improved. We recommend establishing a comprehensive, accurate data sharing system for future vaccine trials.
KW - COVID-19
KW - Data sharing
KW - Randomized controlled trials
KW - Reporting
KW - Vaccine
UR - http://www.scopus.com/inward/record.url?scp=85126959213&partnerID=8YFLogxK
U2 - 10.1016/j.ebiom.2022.103962
DO - 10.1016/j.ebiom.2022.103962
M3 - Journal article
C2 - 35339894
AN - SCOPUS:85126959213
SN - 2352-3964
VL - 78
JO - EBioMedicine
JF - EBioMedicine
M1 - 103962
ER -
