Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study

Yuting Duan, Jingyuan Luo, Lingyun Zhao, Xuan Zhang, Jiangxia Miao, David Moher*, Zhaoxiang Bian*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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. 

Original languageEnglish
Article number103962
JournalEBioMedicine
Volume78
DOIs
Publication statusPublished - Apr 2022

Scopus Subject Areas

  • Biochemistry, Genetics and Molecular Biology(all)

User-Defined Keywords

  • COVID-19
  • Data sharing
  • Randomized controlled trials
  • Reporting
  • Vaccine

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